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503-524-0111 operations@cv-mask.com

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ALL PRODUCTS

 * All Products
 * Masks
 * Eye/Facial Protection
 * Hand Sanitizer
 * Gloves
 * Protective Wear

DISPOSABLE CIVILIAN MASKS FDA/CE 8 CENTS EACH

A civilian mask is a loose-fitting, disposable device that looks like a medical
mask and creates a physical barrier between the mouth and nose of the wearer and
potential contaminants in the immediate

Select Options

DISPOSABLE SURGICAL MASKS LEVEL 2 FDA/CE 15 CENTS EACH

The most recommended option for daily protective wear by caregivers. An extra
level of protection for public use.

Select Options

DISPOSABLE STERILIZED SURGICAL MASKS LEVEL 3 MADE IN USA - 25 CENTS EACH

Level 3 sterilized individually packed disposable surgical mask with FFP3 >99%
filtration

Select Options

KN95 GB2626-2006 MASK 50 CENTS EACH

An alternative option for daily protective wear by caregivers. An extra level up
from disposable medical masks.

Select Options

KN95 RESPIRATOR VALVE 25 CENTS EACH

An alternative option for daily protective wear by categories. An extra level up
from disposable medical class.

Select Options

KN95 NANO FIBER MASK 75 CENTS EACH

The best alternative for daily protective wear by the general public because it
is washable with a high filtration capacity.

Select Options

CE/FDA N95 MASK

An alternative option for daily protective wear by caregivers. An extra level up
from KN95 for public use.

Select Options

NIOSH N95 MASK $1.75 EACH

The gold standard for daily protective wear by caregivers. An extra level up
from N95 for public use.

Select Options

PP ISOLATION GOWN - 35-40 GSM $2 EACH

Safe and reliable full body protection for caregivers - S, M, L, XL Available.

Sizes run large up to next size.



Select Options

SMS MEDICAL GOWN 40 GSM $2.50 EACH

Safe and reliable full body protection for caregivers - S, M, L, XL Available.

Select Options

PROTECTIVE SUIT WITH HOOD SMS/PP 60 GSM $8 EACH

Safe and reliable body protection for civilian and medical caregivers - L, XL,
2X available.

Select Options

DISPOSABLE SHOE COVERS 20 CENTS EACH

Disposable shoe covers - waterproof, dustproof, durable with extra strength
elastic for easy on/easy off.

Select Options

PROTECTIVE FACE SHIELD 50 CENTS EACH

Top-of-the-line EN RoHS certified facial safety protection shield suitable for
caregivers and the general public.

Select Options

FDA MEDICAL NON-FOG GOGGLES $1.50 EACH

Top-of-the-line ANSI Z87-12 Non-fog eye protection safety wear suitable for
caregivers and the general public.

Select Options

DISPOSABLE VINYL GLOVES $50 CASE

Safe and reliable protection from personal hand contacts in the public
marketplace. Only Small Available.

Select Options

DISPOSABLE VINYL GLOVES $80 CASE

Safe and reliable protection from personal hand contacts in the public
marketplace. M, L, XL Available.

Select Options

DISPOSABLE SYNMAX EXAM GLOVES FDA 510K $130 CASE

Safe and reliable protection from hand contacts in health care situations. M and
L now available.

Select Options

DISPOSABLE NITRILE GLOVES FDA 510K $170 CASE

test Safe and reliable protection from personal hand contacts in the public
marketplace. S, M, L, XL available.

Select Options

HAND SANITIZER - 2 OZ. COMPACT 20 CENTS EACH

FDA Registered, Audited & Tested – GMCP Certified – INTERTEK Certified – BSCI &
C-TPAT Audited – SGS Audited.

Select Options

HAND SANITIZER - 3.3 OZ. TRAVEL 33 CENTS EACH

FDA Registered, Audited & Tested – GMCP Certified – INTERTEK Certified – BSCI &
C-TPAT Audited – SGS Audited.

Select Options

HAND SANITIZER - 8 OZ. TABLE PUMP 80 CENTS EACH

FDA Registered, Audited & Tested – GMCP Certified – INTERTEK Certified – BSCI &
C-TPAT Audited – SGS Audited.

Select Options

HAND SANITIZER - 16.9 OZ. TABLE PUMP $1.60 EACH

FDA Registered, Audited & Tested – GMCP Certified – INTERTEK Certified – BSCI &
C-TPAT Audited – SGS Audited.

Select Options

HAND SANITIZER - 1 L PUMP $3.39 EACH

FDA Registered, Audited & Tested – GMCP Certified – INTERTEK Certified – BSCI &
C-TPAT Audited – SGS Audited.

Select Options

HAND SANITIZER - 2 LITER PUMP $6.78 EACH

FDA Registered, Audited & Tested – GMCP Certified – INTERTEK Certified – BSCI &
C-TPAT Audited – SGS Audited.

Select Options

HAND SANITIZER - 4 LITER PUMP $13.56 EACH

FDA Registered, Audited & Tested – GMCP Certified – INTERTEK Certified – BSCI &
C-TPAT Audited – SGS Audited.

Select Options

HAND SANITIZER - 5.2 GALLONS BULK PAIL $50

FDA Registered, Audited & Tested – GMCP Certified – INTERTEK Certified – BSCI &
C-TPAT Audited – SGS Audited.

Select Options

DISPOSABLE CIVILIAN MASKS FDA/CE 8 CENTS EACH

A civilian mask is a loose-fitting, disposable device that looks like a medical
mask and creates a physical barrier between the mouth and nose of the wearer and
potential contaminants in the immediate

Select Options

DISPOSABLE SURGICAL MASKS LEVEL 2 FDA/CE 15 CENTS EACH

The most recommended option for daily protective wear by caregivers. An extra
level of protection for public use.

Select Options

KN95 GB2626-2006 MASK 50 CENTS EACH

An alternative option for daily protective wear by caregivers. An extra level up
from disposable medical masks.

Select Options

KN95 RESPIRATOR VALVE 25 CENTS EACH

An alternative option for daily protective wear by categories. An extra level up
from disposable medical class.

Select Options

KN95 NANO FIBER MASK 75 CENTS EACH

The best alternative for daily protective wear by the general public because it
is washable with a high filtration capacity.

Select Options

CE/FDA N95 MASK

An alternative option for daily protective wear by caregivers. An extra level up
from KN95 for public use.

Select Options

NIOSH N95 MASK $1.75 EACH

The gold standard for daily protective wear by caregivers. An extra level up
from N95 for public use.

Select Options

PROTECTIVE FACE SHIELD 50 CENTS EACH

Top-of-the-line EN RoHS certified facial safety protection shield suitable for
caregivers and the general public.

Select Options

FDA MEDICAL NON-FOG GOGGLES $1.50 EACH

Top-of-the-line ANSI Z87-12 Non-fog eye protection safety wear suitable for
caregivers and the general public.

Select Options

HAND SANITIZER - 2 OZ. COMPACT 20 CENTS EACH

FDA Registered, Audited & Tested – GMCP Certified – INTERTEK Certified – BSCI &
C-TPAT Audited – SGS Audited.

Select Options

HAND SANITIZER - 3.3 OZ. TRAVEL 33 CENTS EACH

FDA Registered, Audited & Tested – GMCP Certified – INTERTEK Certified – BSCI &
C-TPAT Audited – SGS Audited.

Select Options

HAND SANITIZER - 8 OZ. TABLE PUMP 80 CENTS EACH

FDA Registered, Audited & Tested – GMCP Certified – INTERTEK Certified – BSCI &
C-TPAT Audited – SGS Audited.

Select Options

HAND SANITIZER - 16.9 OZ. TABLE PUMP $1.60 EACH

FDA Registered, Audited & Tested – GMCP Certified – INTERTEK Certified – BSCI &
C-TPAT Audited – SGS Audited.

Select Options

HAND SANITIZER - 1 L PUMP $3.39 EACH

FDA Registered, Audited & Tested – GMCP Certified – INTERTEK Certified – BSCI &
C-TPAT Audited – SGS Audited.

Select Options

HAND SANITIZER - 2 LITER PUMP $6.78 EACH

FDA Registered, Audited & Tested – GMCP Certified – INTERTEK Certified – BSCI &
C-TPAT Audited – SGS Audited.

Select Options

HAND SANITIZER - 4 LITER PUMP $13.56 EACH

FDA Registered, Audited & Tested – GMCP Certified – INTERTEK Certified – BSCI &
C-TPAT Audited – SGS Audited.

Select Options

HAND SANITIZER - 5.2 GALLONS BULK PAIL $50

FDA Registered, Audited & Tested – GMCP Certified – INTERTEK Certified – BSCI &
C-TPAT Audited – SGS Audited.

Select Options

DISPOSABLE VINYL GLOVES $50 CASE

Safe and reliable protection from personal hand contacts in the public
marketplace. Only Small Available.

Select Options

DISPOSABLE VINYL GLOVES $80 CASE

Safe and reliable protection from personal hand contacts in the public
marketplace. M, L, XL Available.

Select Options

DISPOSABLE SYNMAX EXAM GLOVES FDA 510K $130 CASE

Safe and reliable protection from hand contacts in health care situations. M and
L now available.

Select Options

DISPOSABLE NITRILE GLOVES FDA 510K $170 CASE

test Safe and reliable protection from personal hand contacts in the public
marketplace. S, M, L, XL available.

Select Options

PP ISOLATION GOWN - 35-40 GSM $2 EACH

Safe and reliable full body protection for caregivers - S, M, L, XL Available.

Sizes run large up to next size.



Select Options

SMS MEDICAL GOWN 40 GSM $2.50 EACH

Safe and reliable full body protection for caregivers - S, M, L, XL Available.

Select Options

PROTECTIVE SUIT WITH HOOD SMS/PP 60 GSM $8 EACH

Safe and reliable body protection for civilian and medical caregivers - L, XL,
2X available.

Select Options

DISPOSABLE SHOE COVERS 20 CENTS EACH

Disposable shoe covers - waterproof, dustproof, durable with extra strength
elastic for easy on/easy off.

Select Options


CDC continues to study the spread and effects of the novel coronavirus across
the United States.  We now know from recent studies that a significant portion
of individuals with coronavirus lack symptoms (“asymptomatic”) and that even
those who eventually develop symptoms (“pre-symptomatic”) can transmit the virus
to others before showing symptoms.  This means that the virus can spread between
people interacting in close proximity—for example, speaking, coughing, or
sneezing—even if those people are not exhibiting symptoms.  In light of this new
evidence, CDC recommends wearing cloth face coverings in public settings where
other social distancing measures are difficult to maintain (e.g., grocery stores
and pharmacies) especially in areas of significant community-based transmission.

The level of protection you require is based on personal preference. For our
products the levels of protective starts at least to most protection:

You see many people wearing washable cotton masks.  These are not certified to
offer protection against air-borne pathogens.  However, they offer protection
better than nothing.  We recommend using certified protective masks that offer a
certifiable level of protection.  Our masks offer protection from ≥60-≥99%

 1. Disposable civilian masks – ≥60%
 2. Disposable medical/surgical masks – ≥80%
 3. KN95 – ≥94%
 4. N95 – ≥95%
 5. N95 NIOSH – ≥95%
 6. Nanofiber – ≥95-99.9%

Face Mask Levels

Respiratory protection in the form of disposable dust masks come in three
respirator ratings: FFP1, FFP2, and FFP3 – FFP stands for “Filtering Face Piece”
and the number denotes the level of protection.

Our inventory of products are rated on the American Society for Testing and
Materials (ASTM). The three levels consist of:

ASTM Level 1 – Low fluid resistance – FFP 1: disposable civilian masks – 3-ply
ASTM Level 2 – Moderate fluid resistance – FFP 2: disposable medical/surgical –
3-ply; KN95 and N95 masks – 4 or 5-ply
ASTM Level 3 – High fluid resistance – FFP3 N99 and FFPN100 masks – 5-ply

Level 1 masks (ASTM low barrier) are designed for procedures with low amounts of
blood, fluid, spray and/or aerosol exposure. Common clinical examples include
patient exams, operatory cleaning, impressions, lab trimming and orthodontic
work.  Level 1 masks are fiberglass/latex free and made with a form-fitting
pliable nose and chin band.

Level 2 masks (ASTM moderate barrier) are ideal for procedures where moderate to
light amounts of fluid, spray and/or aerosols are produced.  Level 2 masks are
suitable for restoratives, prophylaxis, sealants, limited oral surgery and
endodontic work.

Level 3 masks (ASTM high barrier) are designed for procedures with moderate to
heavy amounts of blood, fluid, spray and/or aerosol exposure. High barrier
protection is needed for procedures such as implant placement, crown
preparation, and periodontal or complex oral surgery.  Protecting against high
bacterial infiltration, Level 3 masks feature a 5-ply design with a fluid
resistant outer layer. 

At this point in the coronavirus pandemic, it’s clear that infected people can
spread the virus before they start to show any symptoms.

Because of this, the Centers for Disease Control and Prevention and an
increasing number of state health departments have recommended that most people
wear face coverings or nonmedical masks while out in public. (Certain groups,
such as children under age 2, are excluded from the advice.) 

N95 respirators and surgical masks (face masks) are examples of personal
protective equipment that are used to protect the wearer from airborne particles
and from liquid contaminating the face. Centers for Disease Control and
Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH)
and Occupational Safety and Health Administration (OSHA) also regulate N95
respirators.

It is important to recognize that the optimal way to prevent airborne
transmission is to use a combination of interventions from across the hierarchy
of controls, not just PPE alone.

Medical masks and other face coverings protect other people from the person
wearing the mask. N95 protects the person wearing the mask from other people.

Both N95s and surgical masks are made from melt-blown fabric, which is difficult
and expensive to make.

The material is a fine mesh of synthetic polymer fibers so thin that the wearer
can block infectious particles and breathe simultaneously.

It’s made from a machine that melts down plastic material and blows it out into
fabric sheets using hot air.  The resulting material is called melt-blown
fabric.

A mask is effective only if worn properly, fitting snugly from the top of the
nose to below the chin with no gaps. Masks should be worn the entire time you
are outside, and should not be moved up and down. While no mask is 100 percent
effective, it can help keep both you and others safe when combined with social
distancing and regular hand washing.

Many disposable respirators have anti-microbial surfaces, but over the years
that they could start to be considered home to germs. It is recommended to
change them out after 8-10 hours even if they’re not cluttered.

N95 MASKS

An N95 respirator is a respiratory protective device designed to achieve a very
close facial fit and very efficient filtration of airborne particles.

N95 respirators are approved by NIOSH as to their respiratory protection
efficiency and resistance and other NIOSH requirements. They are also separately
cleared by FDA as medical devices. … Surgical N95 respirators and N95 industrial
respirators share the same NIOSH requirements.  The masks at cv-mask.com are
industrial type.

The ‘N95’ designation means that when subjected to careful testing, the
respirator blocks at least 95 percent of very small (0.3 micron) test particles.
If properly fitted, the filtration capabilities of N95 respirators exceed those
of face masks. However, even a properly fitted N95 respirator does not
completely eliminate the risk of illness or death.

An N95 respirator is a respiratory protective face mask, designed to help reduce
the user’s exposure to airborne particles including very small particles (0.3
microns) and large droplets. N95 respirator face mask literally has a filtration
efficiency of at least 95% against non-oily particles.

The N95 is the most recognizable and effective mask. Its name means it can block
at least 95 percent of tiny particles — 0.3 microns — that are the hardest to
capture. An average human hair is about 70 to 100 microns wide.

These masks, which are designed for single use, are made with polyester and
other synthetic fibers, including layers of tangled fibers that act as a filter
to make it harder for particles to pass through.

N95 respirators are designed to provide a better seal around the face and built
especially to filter smaller particles—the 95 in the name comes from how, in
testing, the respirator blocks 95% of 0.3 micron-sized test particles.
Neither masks nor respirators are intended to be used more than once.

Make sure there are no gaps between the edge of the mask and your skin. This one
includes a nose piece that is molded to your face. Many health care and other
workers do annual fit tests that check for air leakage and ensure that masks are
sized and fit properly. (If you have facial hair, you won’t get a proper fit.
They don’t fit well on children, either.)

One important addition to your respiratory protection plan should
be reuse of N95 respirators during a shortage. The OSHA directive indicates that
a respirator can be reused as long as it “maintains its structural and
functional integrity and the filter material is not physically damaged or
soiled.”

To clean and disinfect appropriate masks, gently wash the mask in warm soapy
water, using dishwashing liquid. Rinse in clean water and plunge the
entire mask body into a disinfection solution of 1/4 cup of non-scented liquid
chlorine bleach per gallon of water.

Masks must be changed when they become wet with saliva or other bodily fluids,
as they lose their protective properties. Medical masks are not tested against
specific microorganisms and do not prevent specific diseases.
Never reuse, wash or disinfect surgical masks. Never share surgical masks with
others.

KN95 masks

The KN95 mask is designed to filter out at least 95% of particles that are 0.3
microns or larger in size – the same measure used for the scarce N95 mask.  Like
the N95, it fits closely around the nose and mouth, creating a seal that
decreases the risk of infection.  And the Center for Disease Control has said
it’s as effective as N95, which is certified under US testing standards.  But
this second type of mask, called the KN95, complies with slightly different
norms and is made in factories that have not been certified by the U.S.
government.

According to 3M, the world’s largest mask manufacturer, the KN95 is “equivalent”
and “can be expected to function very similar” to the N95 mask.  That opinion
was echoed on February 29 by the CDC, which said the KN95 is one of the seven
foreign-certified respirators “expected to provide protection to workers”…

The two rubber bands on an N95 mask go around the back of your head. On a KN95,
the rubber bands go around your ears.

Features of KN95: 100% brand new and high quality

* KN95 level protection, filtering efficiency up to 95%, PM 2.5 pollution ash.
* The production of our masks strictly follows GB2626-2006 (China’s KN95
standard). The technical requirements and test methods of GB2626-2006 (China’s
KN95 standard) are basically consistent with 42 CFR 84 (US standard) for NIOSH
N95..
* Activated carbon layer inside can effectively absorb organic smell and odor.
* High-quality elastic ear-loop with no pressures on the ears, makes it
comfortable to wear for a long time.
* Close fit to prevent polluted air from entering.
* Nose sponge cushion, soft and flexible nose cushion makes mask wearer feel
more comfort.
* Adjustable soft nose clip, fit the bridge of the nose, prevents fogging of
glasses block the haze from entering.
* Wide applications: can be used for electronic manufacturing, dust-free
workshops, catering services, food processing, schools, motorcycles, beauty,
environmental cleaning, public occasions and many other uses. All the filter
efficiency indicators are above 95%.

Disposable Civilian and Medical Masks

Civilian and Medical masks come in a few varieties and are less effective than
N95s: Some filter as much as 60 to 80 percent of small particles under lab
conditions. When worn properly, they can help prevent the spread of the
coronavirus by catching droplets when you cough or sneeze.

Civilian and Medical masks are often made out of layers of breathable,
paper-like synthetic fabric that is cut into a rectangular shape and has pleats
to help it expand and fit more snugly around your face. They are disposable and
designed to be used just once.

While they can protect you from large droplets and splatter, their looser fit is
partly what makes them less effective than N95s.

It has the blue color on the outside because it is waterproof and then you have
white on the inside because it is absorbent. So, if one coughs, it absorbs it.

Medical masks are made to be fluid resistant, with the waterproof layer on the
outside to “minimize the amount of fluid that could transfer from the outer
layers through to the inner layers as the result of a splash or spray,” in
accordance with the American Society of Testing and Materials standards.

The filtration efficiency and protective ability of a civilian/medical face mask
is compromised when the mask becomes wet, torn or dislodged.

Nano-fiber Masks

Respirators with a nanofiber filter are optimal for daily use against smog,
bacteria and other airborne viruses.  Masks made of nanosized fibers have up to
a 99.9% efficiency in stopping viruses and are very comfortable to wear.  The
wearer can breathe as comfortably as wearing a conventional face mask, making it
superb for any outdoor occasions..  The face masks are made up a thin non-woven
fabric with a very low weight nanofiber coating that is ideal with its flexible
structure that easily passes moisture.  This process allows the masks to be
washed regularly, and after 20 washings will still be able to filter about 94%
of contaminants and retain its shape.

Nano-fiber filters are generally used in air filtration systems and are made
through an electro-spinning process that creates an extremely thin, fibrous
material, which is then inlaid in a filter. These nanofiber webs are so taut—and
have such microscopic holes in them—that larger pieces of dust and contaminants
aren’t able to penetrate them. 

Additionally, it maintains its ability to filter out contaminants – like viruses
– even after being washed. This means you will be able to thoroughly wash these
masks before reusing them, a big improvement on having to repeatedly reuse and
cleanse single-use masks. (Though these masks are more sustainable over time
than the N95, they filter out roughly 4% fewer particles than standard masks do,
which is still enough to filter out the virus pathogens.)

Even after undergoing 20 rounds of washing, the nanofiber design is able to
successfully filter 94% of contaminants (namely bacteria with ethanol) and
retained its original shape. 


FAQ'S

WHAT ARE THE DIFFERENCES BETWEEN NANO FIBER AND MELT-BLOWN MASKS?

 

CLASSIFICATION MELT-BLOWN MASK NANOFIBER MASK Characteristics Initial filtration
efficiency sharply decreases as electrostatic force discharge with usage The
greater surface area of nanofibers increases the mechanical filtration
efficiency, able to maintain high efficiency for over 20 washings.

 

WHAT ARE THE DIFFERENCES BETWEEN MEDICAL, N95, KN95?

The FDA regulates medical masks and N95 respirators differently based on their
intended use.

A medical mask is a loose-fitting, disposable device that creates a physical
barrier between the mouth and nose of the wearer and potential contaminants in
the immediate environment. These are often referred to as face masks, although
not all face masks are regulated as medical masks. Note that the edges of the
mask are not designed to form a seal around the nose and mouth.

An N95 respirator is a respiratory protective device designed to achieve a very
close facial fit and very efficient filtration of airborne particles. Note that
the edges of the respirator are designed to form a seal around the nose and
mouth. Surgical N95 Respirators are commonly used in healthcare settings and are
a subset of N95 Filtering Face-piece Respirators (FFRs), often referred to as
N95s.

People with chronic respiratory, cardiac, or other medical conditions that make
breathing difficult should check with their health care provider before using an
N95 respirator because the N95 respirator can make it more difficult for the
wearer to breathe. Some models have exhalation valves that can make breathing
out easier and help reduce heat build-up. Note that N95 respirators with
exhalation valves should not be used when sterile conditions are needed.

All FDA-cleared N95 respirators are labeled as “single-use,” disposable devices.
If your respirator is damaged or soiled, or if breathing becomes difficult, you
should remove the respirator, discard it properly, and replace it with a new
one. To safely discard your N95 respirator, place it in a plastic bag and put it
in the trash. Wash your hands after handling the used respirator.  Due to
shortages, follow the cleaning and disinfecting instructions for KN95, N95 and
NIOSH N95 masks.  Disposable civilian and medical masks are not recommended for
cleaning due to degradation of material make-up of these masks.

N95 respirators are not designed for children or people with facial hair.
Because a proper fit cannot be achieved on children and people with facial hair,
the N95 respirator may not provide full protection.  In this case, using a
disposable or medical mask is recommended.

Most N95 respirators are manufactured for use in construction and other
industrial-type jobs that expose workers to dust and small particles. They are
regulated by the National Personal Protective Technology Laboratory (NPPTL) in
the National Institute for Occupational Safety and Health (NIOSH), which is part
of the Centers for Disease Control and Prevention (CDC)

However, some N95 respirators are intended for use in a health care setting.
Specifically, single-use, disposable respiratory protective devices used and
worn by health care personnel during procedures to protect both the patient and
health care personnel from the transfer of microorganisms, body fluids, and
particulate material. These surgical N95 respirators are class II devices
regulated by the FDA, under 21 CFR 878.4040, and CDC NIOSH under 42 CFR Part 84.

The similarities among medical masks and N95s are:

 * They are tested for fluid resistance, filtration efficiency (particulate
   filtration efficiency and bacterial filtration efficiency), flammability and
   biocompatibility.
 * They should not be shared or reused.

WHEN YOU SEARCH FOR THE N95 RESPIRATORS, THERE ARE MANY RESPIRATORS SUCH AS
KN95, FFP2 THAT APPEARED IN THE SAME BREATH. WHAT’S DIFFERENT BETWEEN THESE
RESPIRATORS OF DIFFERENT LETTERS?

Actually, both the N95, KN95, FFP2 respirators have almost the same filtration
efficiency, it means that KN95, FFP2 are as effective as the N95 respirator
mask. The main difference between these respirators is that they are tested by
different nations.

The N95 mask has a full name of NIOSH-certified N95 respirator, which means
these respirators are tested of 95% filtration and certified by the U.S.
National Institute of Occupational Safety and Health (NIOSH). The KN95
respirator is a particulate-filtering mask tested using the China criteria. The
FFP2 is a filtering face-piece score of 94% filter capacity approved by Europe..

To simply put, we could put these respirators into an equation as below:

N100 (99.97%) = FFP3 (99.95%) > N95 (95%) = KN95 (95%) = FFP2 (94%).

Of all the body parts that PPE protects, the face and eyes are among the most
vulnerable.  Many safety incidents involve a workers’ face or eyes getting
struck by an object, injured by flying particles, burned by acids or chemicals,
or exposed to light radiation.  In many of these cases, a worker suffers
permanent damage to their vision or even goes blind.

Workers and their employers frequently underestimate the risk of eye and face
injuries.  Employees may neglect to wear eye and face protection or remove their
PPE before it is safe to do so.  Common complaints are that the PPE doesn’t fit
comfortably, is too hot, or makes the wearer look unattractive.  For goggles and
safety glasses in particular, a major problem is the equipment fogging up,
causing the wearer to periodically remove it and clean off moisture.
 CV-MASK.COM sell only non-fog goggles.

PROTECTIVE FACE SHIELD

A face shield is classified as personal protective equipment (PPE) that provides
barrier protection to the facial area and related mucous membranes (eyes, nose,
lips).

A face shield is a device used to protect wearer’s entire face (or part of it)
from hazards such as flying objects and road debris, chemical splashes (in
industry), or potentially infectious materials (in medical and laboratory
environments).

Purpose. Eye and face protection shall be required where there is a reasonable
probability that injury could be prevented by such protection. PPE shall be
selected in accordance with IOSH 1910.133, Eye and Face Protection.

PROTECTIVE FACE SHIELD ATTRIBUTES:

The rigid frame is padded and holds it shape, providing a comfortable design
that allows the user to wear for many hours.
Foam insert prevent particles from entering from above and increases rigidity.
Glass, masks, and most goggles fit comfortable underneath the shield which is
held almost 2” away from the face.
The shield is made from a flexible transparent plastic that is easy to clean.
Our face shield is incredibly lightweight at just 2.4 ozs.

NON-FOG EYE GOGGLES

There’s a long-standing myth that wearing safety glasses can harm your vision.
Workers are worried if it’s healthy for their eyes to be looking through a
“plastic” (aka polycarbonate) lens all day while on the job. … The short answer
is no – wearing safety eyewear cannot damage your vision.

Safety goggles are important for a number of reasons. To begin with, they allow
the wearer to handle potentially harmful chemicals without fear of damaging
their eyes. This can also be true to biological matter. … Safety goggles can
also help to protect an individual from harm to the eye from physical trauma.

NON-FOG GOGGLES ATTRIBUTES:

Most impact-resistant of all lens materials.

It can be coated for scratch resistance.
Does not fog
Has built-in UV radiation absorption properties.
Eye protection is protective gear for the eyes, and sometimes face, designed to
reduce the risk of injury. Examples of risks requiring eye protection can
include: impact from particles or debris, light or radiation, wind blast, heat,
sea spray or impact from some type of ball or puck used in sports.

The most popular lens material for safety eyewear is polycarbonate. This
material has less than half the weight of glass making the eyewear more
comfortable to wear. Polycarbonate lenses are also more impact-resistant than
glass lenses and do not shatter.


FAQ'S

ARE THERE ANY STUDIES ON USING PROTECTIVE FACE SHIELDS AND GOGGLES?

Journal of Occupational and Environmental Hygiene

Taylor & Francis

J Occup Environ Hyg. 2016; 13(4): 235–242.

Published online 2016 Feb 22. doi: 10.1080/15459624.2015.1095302

PMCID: PMC5015006

NIHMSID: NIHMS814057

PMID: 26558413

Face shields for infection control: A review

Raymond J. Roberge

 

Face shields are personal protective equipment devices that are used by many
workers (e.g., medical, dental, veterinary) for protection of the facial area
and associated mucous membranes (eyes, nose, mouth) from splashes, sprays, and
spatter of body fluids. Face shields are generally not used alone, but in
conjunction with other protective equipment and are therefore classified as
adjunctive personal protective equipment. Although there are millions of
potential users of face shields, guidelines for their use vary between
governmental agencies and professional societies and little research is
available regarding their efficacy.

Healthcare workers’ faces have been reported to be the body part most commonly
contaminated by splashes, sprays and spatter of body fluids.[1] A face shield is
classified as personal protective equipment (PPE) that provides barrier
protection to the facial area and related mucous membranes (eyes, nose, lips). A
face shield offers a number of potential advantages, as well as some
disadvantages, compared with other forms of face/eye protection used in
healthcare and related fields

The introduction of the Occupational Safety and Health Administration’s (OSHA)
Bloodborne Pathogens Standard 1910.1–030,[7] as well as recent outbreaks of
serious airborne infectious diseases (e.g., Severe Acute Respiratory Syndrome
[SARS], Avian Influenza, etc.) and severe infectious agents associated with the
potential for body fluid exposures (e.g., Ebola virus), have resulted in
increased attention to face/eye protection.

Advantages · -more comfortable



· -protect a larger portion of the face

· -less retained dermal facial heat

· -less fogging than goggles

· -less claustrophobic

· -no impact on breathing resistance

· -no fit testing required

· -can be disinfected easily

· -wearers do not need to be clean shaven

· -easy to don and doff

· -relatively inexpensive

· -no impact on vocalization

· -can be worn concurrent to other face/eye PPE

· -do not impede facial nonverbal communication

· -reduced patient anxiety

· -protects against self-inoculation over a wider facial area

· -may extend the useful life of a protective facemask when used concurrently

Disadvantages



· -glare

· -fogging

· -optically imperfect

· -some models may not fit properly over some respirators (e.g., duckbill
filtering facepiece respirators)

· -bulkier than goggles and safety glasses

· -peripheral fit poorer than protective facemasks

 

Disposable one-piece face/neck length face shield visor assembly with foam
forehead cushion and elastic strap.

Face shields provide a barrier to acutely-expelled aerosols of body fluids and
are commonly used as an alternative to goggles as they confer protection to a
larger area of the face.[12] However, as highlighted in a recent Institute of
Medicine report,[15] little is known about the effectiveness of face shields in
preventing the transmission of viral respiratory diseases. Utilizing a cough
aerosol simulator loaded with influenza virus (aerosol volume mean diameter of
8.5 µm) and a breathing simulator, Lindsley et al.[16] reported 96% and 92%
reductions in the risk of inhalational exposure immediately after a cough for a
face shield at distances of 18 in (46 cm) and 72 in (183 cm), respectively.
Decreasing the aerosol size to 3.4 µm resulted in the face shield blocking 68%
of the inhalational exposure at 18 in (46 cm) immediately after the cough and
23% over 1–30 min post-cough (during which time the larger aerosol particles had
settled out and droplet nuclei had formed and remained airborne so that flow
occurred more easily around the edges of the face shield).[16] Shoham et al.[17]

They found that a face shield with head/neck length, three separate contact
points at the forehead, and side curve reaching to the point of the ear
(Bettershield™, Southmedic, Barrie, Ontario, CA), or the combination of this
face shield and an N95 filtering facepiece respirator (N95 FFR), protected the
eyes, nares and mouth from contamination.

There is great variance in official (governmental) and professional society
(medical, dental, etc.) guidelines for the appropriate use of face shields in
the context of protection from biological hazards. Healthcare Infection Control
Practices Advisory Committee/CDC Standard Precautions guidelines for prevention
of transmission of infectious agents in healthcare venues includes the use of
face shields (with a medical/surgical face mask) when sprays, splashes, or
splatter are anticipated.[30] The World Health Organization’s health care
facility recommendations for standard precautions include a face shield as an
alternative to the use of a medical/surgical or procedural mask with eye
protection (eye visor or goggles).[31] Similarly, the Ohio State Dental Board
guidelines for infection control states that dental healthcare workers need not
wear medical/surgical masks when wearing an appropriate face shield that
provides protection at both the top and the sides.32] The Organization for
Safety, Asepsis, and Protection, an advocacy group for dental practitioners,
advises that use of a face shield alone for protection from contamination by
body fluids is likely insufficient, and it is prudent to assume that in those
situations where a face shield is used to protect against splash or splatter, a
medical/surgical mask would also be indicated.

The use of a minimum of an N95 FFR, concurrent with a face shield, has been
advocated for protection from serious airborne respiratory infectious diseases
(e.g., novel influenza A viruses, SARS) and during procedures on infected
persons that result in aerosolization of body fluids (airway suctioning,
intubation, etc.).

Face shields are meant to be used as barrier protection for the facial area and
associated mucous membranes from airborne body fluids (blood, saliva, bronchial
secretions, vomit, urine, etc.) expelled as a result of various physiological
processes (vomiting, coughing, sneezing, etc.) and medical, dental, and
veterinary procedures (suctioning the airway, placing nasogastric tubes,
obstetrical procedures, surgery, dental procedures, etc.).

Appropriately fitted, indirectly vented goggles offer the most reliable
practical eye protection from splashes, but face shields are considered an
alternative to goggles for prevention of eye contamination with infectious
agents.

Use of a face shield alone for eye, face, and mucous membrane protection from
contamination by body fluids is likely insufficient and it has been recommended
that in those situations where a face shield is used to protect against splash
or splatter, a medical/surgical mask would also be indicated.

WHAT IS THE BEST WAY TO CLEAN PROTECTIVE FACE SHIELDS AND GOGGLES?

 1. While wearing gloves, carefully wipe the inside, followed by the outside of
    the face shield or goggles using a clean cloth saturated with neutral
    detergent solution or cleaner wipe.
 2. Carefully wipe the outside of the face shield or goggles using a wipe or
    clean cloth saturated with EPA-registered hospital disinfectant solution.
 3. Wipe the outside of face shield or goggles with clean water or alcohol to
    remove residue.
 4. Fully dry (air dry or use clean absorbent towels).
 5. Remove gloves and perform hand hygiene.

WHAT ADVANTAGE DOES WEARING A PROTECTIVE FACE SHIELD OFFER?

A face shield can provide additional protection to other facial areas that
safety glasses or goggles cannot. Face shields are considered to be a secondary
protector and must always be worn over protective safety glasses or goggles. To
provide better face and eye protection from splashes and sprays, a face shield
should have crown and chin protection and wrap around the face to the point of
the ear, which reduces the likelihood that a splash could go around the edge of
the shield and reach the eyes. Disposable face shields for medical personnel
made of light weight films that are attached to a surgical mask or fit loosely
around the face should not be relied upon as optimal protection. Cartridge
respirators not only have the ability to filter the air before you breathe, but
can also be used as eye protection. They will protect the eyes and all parts of
the face.

WHAT ARE FACE SHIELDS MADE OF?

The face shields are made from a clear flexible acetate or polypropylene (PP)
material at 5 to 10 mils thick.

CAN I WEAR MY GLASSES WITH EYE GOGGLES?

CV-MASK.COM’s non-fog eye goggles fit adequately over prescription glasses with
minimal gaps. However, to be efficacious, goggles must fit snugly, particularly
from the corners of the eye across the brow. While highly effective as eye
protection, goggles do not provide splash or spray protection to other parts of
the face.

WHAT DO EYE GOGGLES PROTECT FROM?

Protective goggles form a protective seal around both eyes where the material is
tight or flush to the face. Appropriately fitted, indirectly-vented goggles*
with a manufacturer’s anti-fog coating provide the most reliable practical eye
protection from splashes, sprays, and respiratory droplets. Newer styles of
goggles may provide better indirect airflow properties to reduce fogging, as
well as better peripheral vision and more size options for fitting goggles to
different workers.

WHICH EYE OR FACE PROTECTION IS BEST TO USE?

Think Safety Glasses AND Face Shield

However, you should always wear safety glasses under your face shield because
the bottom and sides of face shields typically have gaps. Liquid or debris
passing through these gaps can contact your eyes, potentially causing an injury.

All protectors must:

 * Provide adequate protection against the particular hazards for which they are
   designed.
 * Be of safe design and construction for the work to be performed.
 * Be reasonably comfortable when worn under the designated conditions.
 * Fit snugly and not unduly interfere with the movements of the wearer.
 * Be durable.
 * Be capable of being disinfected.
 * Be easily cleanable.
 * Be distinctly marked to facilitate identification only of the manufacturer.

Our hand sanitizers are FDA Registered & Audited– GMCP Certified – INTERTEK
Certified – BSCI & C-TPAT Audited – SGS Audited.

Our hand sanitizers have been audited by the FDA, reviewed and tested by FDA
laboratories for safe and authentic ingredients conforming to FDA labeling
requirements.
Our hand sanitizers are third party (independently) verified by SGS for ETHANOL
(Ethyl Alcohol) content, ingredient identification, and label conformance.

Third-party testing assures safety and reliability for you.

It is the same as sold to brands Americans trust including DISNEY, WALMART,
FAMILY DOLLAR, WATSON’S & other internationally known brands.

The ingredients of our hand sanitizer are ethyl alcohol (75%), water, glycerin,
carbomer, aloe vera gel, propylene glycol, triethanolamine, fragrance, vitamin
E.

Alcohol has been used as an antiseptic at least as early as 1363 with evidence
to support its use becoming available in the late 1800s.   Alcohol-based hand
sanitizer has been commonly used in the west since at least the 1980s.   The
alcohol-based version is on the World Health Organization's List of Essential
Medicines, the safest and most effective medicines needed in a health system.

Benefits of waterless hand sanitizer:

 * * Require less time than hand

 * * Act quickly to kill microorganisms on hands.

 * * Are more accessible than sinks.

 * * Reduce bacterial counts on hands.

 * * Do not promote antimicrobial resistance.

 * * Are less irritating to the skin than soap and water.

 * * Some can even improve the condition of the skin.

Health officials say that soap and water is the best way to keep your hands
virus-free. When you’re not near a sink, the experts say, hand sanitizers are
the next best thing. To get the maximum benefit from hand sanitizers,
the Centers for Disease Control and Prevention (CDC) recommends that people use
a product that contains at least 60% alcohol, cover all surfaces of their hands
with the product, and rub them together until dry.

Our hand sanitizer is composed of 75% ethyl alcohol.  Care should be taken as
they are flammable.   Alcohol-based hand sanitizer works against a wide variety
of microorganisms.  Compounds such as glycerol (propylene glycol) are added to
prevent drying of the skin.   Non-alcohol based versions typically
contain benzalkonium chloride or triclosan; but are less effective than
alcohol-based ones.



NITRILE GLOVES

Attributes include:

 * Latex-free
 * Are most puncture-resistant
 * Have a high level of sensitivity
 * Mold to your hand for a great fit
 * Are good for wearing an extended amount of time
 * Work well for high-risk situations involving infectious material
 * Resist many chemicals
 * Have a long shelf life
 * Are available in blue, black and white to help identify if the glove has been
   punctured

 * 

Nitrile is short for acrylonitrile-butadiene rubber. This material is created
from monomers – acrylonitrile and butadiene – which are molecules that are
bonded together. Nitrile gloves come in a wide variety of colors, which can help
to differentiate sizing and prevent cross-contamination.

Nitrile is waterproof, greaseproof, oil proof, and most importantly, chemical
resistant to a range of common chemicals and substances. Nitrile gloves are also
commonly used in the medical industry due to their high puncture resistance, and
dexterous strength.

Since Nitrile gloves are made out of synthetic rubber, they are an ideal
alternative when latex allergies are of concern.  Nitrile gloves are the
superior glove when it comes to puncture resistance.  Nitrile gloves are often
referred to as “medical grade.”

Nitrile gloves are therefore more puncture-resistant than natural rubber gloves,
especially if the latter are degraded by exposure to chemicals or ozone. 
Nitrile rubber is less likely to cause an allergic reaction than natural rubber.

In general, nitrile is often considered premium to latex, which in turn is often
considered premium to vinyl.  The fact is that materials are not equal in
performance in all applications.  CV-MASK.COM does not sale latex gloves.

Nitrile gloves are preferred over latex because of their chemical resistance,
their tendency to visibly rip when punctured and to prevent possible latex
allergies.

Check the gloves for:

 * Rips or punctures before and after each use.
 * Prior contamination.
 * Signs of degradation (change in color or texture)

 

VINYL GLOVES

Vinyl gloves are a popular choice for the food industry and situations where
high levels of durability and protection are less of a priority.  While they may
be less durable, they are the less expensive option.

Attributes include:

 * Latex-free
 * Have a looser fit
 * Are good for short-term, low-risk tasks
 * Are the most economic option
 * Have anti-static properties
 * Are best for use with non-hazardous materials

So, when it comes time to decide which type of protective glove is the right
choice for you, the most important thing to consider is….how much protection do
you need.

How To Remove Gloves


FAQ'S

WHAT IS THE STRONGEST GLOVE TO USE?

Am J Infect Control. 1999 Oct;27(5):405-10.

In-use barrier integrity of gloves: latex and nitrile superior to vinyl.

Rego A1, Roley L.

This study indicates that the latex and nitrile gloves evaluated were comparable
in terms of barrier performance characteristics both unused and during
manipulations mimicking patient care procedures.  Whereas stretch vinyl
exhibited lower failure rates than standard vinyl, the higher in-use leakage
rates associated with all vinyl gloves tested indicate decreased durability and,
potentially, compromised barrier protection when this synthetic is used.
 Careful consideration to the degree of barrier effectiveness should be given
before glove selection when the potential exposure to blood-borne pathogens or
biohazard risks is a concern.

WHAT ARE VINYL GLOVES MADE OF?

Vinyl gloves, also called PVC gloves, contain a heavy chlorine content.  PVC is
a widely produced synthetic plastic polymer. … And, the European Union in 2008
banned the use in food safety products of at least one material used in
making vinyl gloves out of concern the chemical could leach into food and be
ingested.

Vinyl gloves, which are made from PVC (polyvinyl chloride), are usually the
cheapest latex-free gloves. However, many prefer to use higher-end gloves such
as nitrile gloves. … In general, latex gloves offer the best protection
against bacteria and viruses, while synthetic gloves provide better
chemical protection.

Gloves made from vinyl are manufactured in a way to enable stretch and
versatility whilst they are also able to hold up against punctures, stretch and
general wear and tear. They can be used for healthcare tasks, keeping hands safe
from contamination.

Four phthalates were found in some vinyl gloves, alone or in combination with
one another: DEHP (the most toxic), DINP (the unsafe alternative), DIDP (has
growing concern) and DPHP (closely related to DIDP, increasingly used).

Phthalates. Up to 50% of disposable vinyl gloves are made up of plasticizers,
which make the PVC flexible and soft enough to wear. Often plasticizers contain
phthalates and BPA as they are inexpensive.

Up to 50% of disposable vinyl gloves are made up of plasticizers, which make
the PVC flexible and soft enough to wear. Often plasticizers contain phthalates
and BPA as they are inexpensive. Phthalate plasticizers can be absorbed through
worker’s skin and quickly transfer to, and contaminate food products.

Vinyl is a synthetic, non-bio-degradable, protein-free material made from
polyvinyl chloride (PVC) and plasticizers. Since vinyl gloves are synthetic and
non-biodegradable, they have a longer shelf life than latex gloves, which often
start to break down over time.

WHAT DO DISPOSABLE GLOVES PROTECT AGAINST?

Nitrile gloves protect against most chemicals and infectious agents. Neoprene
gloves protect against most solvents, oils, and mild corrosive materials. Avoid
latex gloves as many people are allergic or develop allergies to this material.

Nitrile rubber gloves offer superior puncture-resistant to latex gloves. Nitrile
rubber gloves offer a greater chemical resistance over Latex and vinyl to
chemicals, oils, and acids, and have superior strength. This type of glove
creates a better barrier for protection.

It is important to wear gloves when working with hazardous chemicals and other
materials because they protect our hands from infection and contamination.
Protective gloves should be selected on the basis of the hazards involved.
Nitrile gloves protect against most chemicals and infectious agents.

CAN DISPOSABLE GLOVES DISINTEGRATE?

Like other glove types, nitrile gloves are sensitive to alcohol degradation.
They have been found to be sensitive to ozone degradation and can be somewhat
brittle and stiffer than latex. Nitrile gloves may contain
bis(2-Ethylhexyl)phthalate, or DEHP, recognized as carcinogenic.

WHAT IS THE BEST WAY TO PUT ON DIPOSABLE GLOVES?

An easy way to do this is first put the nitrile or latex glove on your dominant
hand, while touching it as little as possible. Then, put the other glove on your
non dominant hand, using your gloved dominant hand to pull it on. Once
both gloves are on your hands you can adjust your fingers and the fit of
the glove.

HOW IMPORTANT IS THE THICKNESS OF DISPOSABLE GLOVES?

Most disposable nitrile gloves come in different thicknesses, or gauges, ranging
from four to eight mil thick. The vast majority of heavy duty industrial grade
nitrile gloves will be 6 – 8 mils thick.

WHAT ARE NITRILE GLOVES MADE OF?

Nitrile is a synthetic rubber copolymer of acrylonitrile and butadiene. These
two materials (monomers) are placed in a stainless steel vat, and using hot or
cold polymerization, a chemical reaction occurs, and voila! Nitrile is born.

WHAT IS THE SHELF LIFE OF DISPOSABLE GLOVES?

While an exact shelf life time period is dependent on what specific material
the gloves are made of and storage facilities, a general rule of thumb is three
years for disposable natural latex gloves and up to five years for
disposable nitrile gloves.

CAN I WASH OR DISINFECT USED DISPOSABLE GLOVES?

Yes, they can be washed as long as no material degradation is present.  We
recommend hand washing your Nitrile gloves or Vinyl gloves in a sink using mild
laundry detergent or dishwashing soap.  DO NOT use bleach or solvents as these
oxidizing agents can cause discoloration.  We recommend air-drying
your gloves to prevent any material shrinkage and maintain proper sizing.

CAN DISPOSABLE GLOVES BE REUSED?

Nitrile gloves are designed not to be reused, actually.  But, if you’re careful
about how you pull them off, it’s possible to get a couple of uses out of them.
The tricky part is getting them from inside-out (which they’ll be after you pull
them off) back to right-side-out again, especially with the very thin ones.

WHY DO DISPOSABLE GLOVES COME IN DIFFERENT COLORS?

Traditionally Nitrile gloves come in a blue hue in order to differentiate them
as a non-latex glove for people with latex allergies.  The reason for such color
variation in Nitrile gloves is mostly due to industry preference.  They can come
in the colors of the rainbow, but the most typical colors are blue, black and
white.  No matter the color they all work the same.

WILL GLOVES CAUSE ALLERGIES?

Yes, they can.  Some users of nitrile gloves have reported allergic reactions
triggered by other antigens in the synthetic material but not by latex proteins,
which cause latex allergies. … Three main kinds of
accelerators cause contact dermatitis: carbamates, mercaptobenzothiazole (MBT),
and thiurams.

Glove-related allergies are a primary concern for many glove users. The belief
that glove-related allergies are caused only by natural latex is a common one.
 Latex allergies are the most serious glove allergies because they can be
systemic and cause anaphylactic shock.  Latex allergies are also the most common
type of glove allergies.

Some users confuse chemical allergies with latex allergies.  There are often
components in both nitrile and vinyl gloves that can elicit a chemical allergy.
 For example, nitrile gloves, like natural latex gloves, often use carbamates or
thiazoles, which can cause a skin allergy.  Certain vinyl gloves use activation
agents that can also cause skin allergies. In all cases, the less a glove is
washed, the more chemical residue is available for potential contact to the
user.  Users should consult their physician if they suspect an allergy to
gloves.

Latex allergies are the most serious glove allergies because they can be
systemic and cause anaphylactic shock. … For example, nitrile gloves, like
natural latex gloves, often use carbamates or thiazoles, which can cause a skin
allergy.  Certain vinyl gloves use activation agents that can also cause skin
allergies.  CV-MASK.COM does not offer latex gloves for sale.

Even more rarely, there are sometimes trace amounts of latex found in nitrile
gloves, which causes a latex allergy that is falsely attributed to the nitrile
glove.  The typical symptoms associated with an allergic reaction to nitrile
gloves are listed below: Redness of hands. Rhinitis: stuffy or runny nose.

Toxicity of medical glove materials: a pilot study.  Lönnroth EC(1). Author
information: … One synthetic rubber glove (nitrile rubber) and 2 synthetic
polymeric gloves (polyvinyl chloride) were non-toxic in all 3 tests.

These page is from CDC description of gowns:
https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns#g1

Gowns are examples of personal protective equipment used in health care
settings.  They are used to protect the wearer from the spread of infection or
illness if the wearer comes in contact with potentially infectious liquid and
solid material. They may also be used to help prevent the gown wearer from
transferring microorganisms that could harm vulnerable patients, such as those
with weakened immune systems.  Gowns are one part of an overall
infection-control strategy.

A few of the many terms that have been used to refer to gowns intended for use
in health care settings, include  surgical gowns, isolation gowns, surgical
isolation gowns, nonsurgical gowns, procedural gowns, and operating room gowns.

In 2004, the FDA recognized the consensus standard American National Standards
Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI)
PB70:2003, “Liquid barrier performance and classification of protective apparel
and drapes intended for use in health care facilities.” New terminology in the
standard describes the barrier protection levels of gowns and other protective
apparel intended for use in health care facilities and specifies test methods
and performance results necessary to verify and validate that the gown provides
the newly defined levels of protection:

Level 1: Minimal risk, to be used, for example, during basic care, standard
isolation, cover gown for visitors, or in a standard medical unit
Level 2: Low risk, to be used, for example, during blood draw, suturing, in the
Intensive Care Unit (ICU), or a pathology lab
Level 3: Moderate risk, to be used, for example, during arterial blood draw,
inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases
Level 4: High risk, to be used, for example, during long, fluid intense
procedures, surgery,  when pathogen resistance is needed or infectious diseases
are suspected (non-airborne)

Regardless of how the product is named (that is, isolation gown, procedure gown,
or cover gown), when choosing gowns, look for product labeling that describes an
intended use with the desired level of protection based on the above risk
levels. Product names are not standardized.

CV-MASK.COM ONLY SELLS NON-SURGICAL ISOLATION CLASS I GOWNS.

OUR GOWNS ARE NOT PRE-STERILIZED AND MEET ASTM STANDARDS FOR MEDICAL USE.  OUR
GOWNS ARE EXPORT CONTROLLED TO MEET THE STANDARDS OF GOWNS ASSIGNED BY THE FDA.

Non-Surgical (ISOLATION) Gowns

Non-surgical gowns are Class I devices (exempt from premarket review) intended
to protect the wearer from the transfer of microorganisms and body fluids in low
or minimal risk patient isolation situations. Non-surgical gowns are not worn
during surgical procedures, invasive procedures, or when there is a medium to
high risk of contamination.

Like surgical isolation gowns, non-surgical gowns should also cover as much of
the body as is appropriate to the task.  As referenced in below Figure, all
areas of the non-surgical gown except bindings, cuffs, and hems are considered
critical zones of protection and must meet the highest liquid barrier protection
level for which the gown is rated.  All seams must have the same liquid barrier
protection as the rest of the gown.



Figure – Critical Zones for Surgical Isolation Gowns and Non-Surgical Gowns

The entire gown (areas A, B, and C), including seams but excluding cuff, hems,
and bindings, is required to have a barrier performance of at least Level 1.
Surgical isolation gowns are used when there is a medium to high risk of
contamination and need for larger critical zones than traditional surgical
gowns.

Standards for Gowns

Labeling that shows a product has been tested to and meets appropriate
performance standards is one way for users and procurers to determine when to
use a particular gown.

The performance of gowns is tested using consensus standards:

American Society for Testing and Materials (ASTM) F2407 is an umbrella document
which describes testing for surgical gowns:  tear resistance, seam strength,
lint generation, evaporative resistance, and water vapor transmission.

Below is a summary of ASTM F2407 standard recognized by the FDA.

Tensile Strength: ASTM D5034, ASTM D1682
Tear resistance: ASTM D5587(woven), ASTM D5587 (nonwoven), ASTM  D1424
Seam Strength: ASTM D751 (stretch woven or knit)
Lint Generation (ISO 9073 Part 10)
Water vapor transmission (breathability) ASTM F1868 Part B, ASTM D6701
(nonwoven), ASTM D737-75

American National Standards Institute (ANSI) and the Association of the
Advancement of Medical Instrumentation (AAMI): ANSI/AAMI PB70:2003 describes
liquid barrier performance and classification of protective apparel and drapes
intended for use in health care facilities.


FAQ'S

HOW DO YOU STERILIZE A NON-STERILE GOWN?

Due to the high degree of hygiene required by the medical field, the standard
version of these disposable surgical gowns can be sterilized in an autoclave at
134°C.

CLICK THIS LINK TO REVIEW STUDIES OF NON-STERILE ISOLATION GOWNS:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4791533/

CLICK THIS LINK TO REVIEW WHAT ARE AND THE DIFFERENCES BETWEEN SMS AND PP
MATERIAL USED IN MOST MEDICAL GOWNS:

http://www.heilymed.com/en/aboutus/industry_news/20170921/123.html

CLICK THIS LINK TO REVIEW A STUDY OF NON-WOVEN SURGICAL GOWNS:

https://www.researchgate.net/publication/258152943_Studies_on_the_properties_of_nonwoven_surgical_gowns


CV MASK LLC - AN OREGON CORPORATION

ADDRESS

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BEAVERTON OR 97005 USA

PHONE

503-524-0111

Fax# 503-524-0112

EMAIL

sales@cv-mask.com
operations@cv-mask.com

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