www.bodygard.com.tr Open in urlscan Pro
94.73.160.67  Public Scan

Form analysis
1 forms found in the DOM

POST javascript:;

<form id="bulten-form" method="post" action="javascript:;" novalidate="novalidate">
  <input type="email" name="email" placeholder="E-Mail">
  <button type="submit"><i class="fa fa-paper-plane-o"></i></button>
</form>

Text Content

You are Safe with Bodygard!

Select Language ▼
TR Price Offer / Sample Request   

 * Homepage
 * About Us
 * Products
 * Technology
 * Blog
 * Contact
 * E-Store



Products


STERILE SURGICAL GOWN BODYGARD LEVEL 3 SFS

BODYGARD? SFS LEVEL 3 surgical gowns are available in EN 13795 High Performance/
AAMI LEVEL 3  gowns and suitable for most procedures. BODYGARD surgical gowns
SFS65 LEVEL 3 are made from a breathable, textile-like, Superfiber spunbond
material that is comfortable to wear.

They are ergonomic too. Shoulder pleats allow freedom of movement for the upper
body and the ergonomic sleeves allow comfort and freedom of movement.The gown
cuff is compatible with  gloves, preventing the gloves from sliding off.

Choose our High Performance gown with impermeable front and sleeves for added
protection against strike-through.

 * Ergonomic fit, enables freedom of movement
 * Breathable, textile-like spunlace material is comfortable to wear
 * Specially treated to repel low-tension surface fluids
 * Available in Standard or ? for added protection against strike-through ? High
   Performance
 * Our gown can be included in M?lnlycke? Procedure trays to support OR
   Efficiency

 

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.

 


SURGICAL GOWNS

A surgical gown is regulated by the FDA as a Class II medical device that
requires a 510(k) premarket notification.  A surgical gown is a personal
protective garment intended to be worn by health care personnel during surgical
procedures to protect both the patient and health care personnel from the
transfer of microorganisms, body fluids, and particulate matter. Because of the
controlled nature of surgical procedures, critical zones of protection have been
described by national standards.  As referenced in Figure 1: the critical zones
include the front of the body from top of shoulders to knees and the arms from
the wrist cuff to above the elbow.  Surgical gowns can be used for any risk
level (Levels 1-4).  All surgical gowns must be labeled as a surgical gown.

 


SURGICAL ISOLATION GOWNS

Surgical isolation gowns are used when there is a medium to high risk of
contamination and a need for larger critical zones than traditional surgical
gowns.  Surgical isolation gowns, like surgical gowns, are regulated by the FDA
as a Class II medical device that requires a 510(k) premarket notification.  As
referenced in Figure 2, all areas of the surgical isolation 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. 
Additionally, the fabric of the surgical isolation gown should cover as much of
the body as is appropriate for the intended use.

 


ON-SURGICAL 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 Figure 2, 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 1 - Critical Zones for Surgical Gowns

 * The entire front of the gown (areas A, B, and C) is required to have a
   barrier performance of at least level 1.
 * The critical zone compromises at least areas A and B.
 * The back of the surgical gown (area D) may be nonprotective.

Figure 2 - 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.

Below is a table summarizing the ANSI/AAMI PB70 standard recognized by the FDA.

Type of PPEFeature TestedStandard DesignationSub
headingsDescriptionApplicabilityGownsLiquid Barrier PerformanceAAMI PB70:2012 

Classifies a gown's ability to act as a barrier to penetration by liquids or
liquid-borne pathogens based on four levels.

The critical protective zones for surgical and non-surgical gowns are defined
differently by the standard.

While the critical zones designate different protective areas for the different
gowns, the levels of protection are the same for both surgical and non-surgical
gowns

Liquid barrier performance is not related to the strength of the material. 

This standard references several other standards

Level 1
 * Used for MINIMAL risk situations
 * Provides a slight barrier to small amounts of fluid penetration
 * Single test of water impacting the surface of the gown material is conducted
   to assess barrier protection performance.

basic care, standard hospital medical unitLevel 2
 * Used in LOW risk situations
 * Provides a barrier to larger amounts of fluid penetration through splatter
   and some fluid exposure through soaking
 * Two tests are conducted to assess barrier protection performance:
   * Water impacting the surface of the gown material
   * Pressurizing the material

Blood draw from a vein, Suturing, Intensive care unit, Pathology labLevel 3
 * Used in MODERATE risk situations
 * Provides a barrier to larger amounts of fluid penetration through splatter
   and more fluid exposure through soaking than Level 2
 * Two tests are conducted to test barrier protection performance:
   * Water impacting the surface of the gown material
   * Pressurizing the material

Arterial blood draw, Inserting an  IV, Emergency Room, TraumaLevel 4
 * Used in HIGH risk situations
 * Prevents all fluid penetration for up to 1 hour
 * May prevent VIRUS penetration for up to 1 hour
 * In addition to the other tests conducted under levels 1-3, barrier level
   performance is tested with a simulated blood containing a virus. If no virus
   is found at the end of the test, the gown passes.

Pathogen resistance, Infectious diseases (non-airborne), Large amounts of fluid
exposure over long periods

Conformance with recognized consensus standards is voluntary for a medical
device manufacturer. A manufacturer may choose to conform to applicable
recognized standards or may choose to address relevant issues in another manner.

 


STERILITY INFORMATION FOR GOWNS

For a device sold sterile, the FELIX recommends sponsors provide the following
information as detailed in the final guidance

 * Sterilization method that will be used.
 * A description of the method that will be used to validate the sterilization
   cycle, but not the validation data itself (for established sterilization
   methods).
 * Reference to a standard method (e.g., AAMI Radiation Standard) usually is
   sufficient for established sterilization methods with FDA-recognized
   standards.
 * The sterility assurance level (SAL) for the device which the firm intends to
   meet. An SAL of 10-6 is required for surgical drapes and surgical gowns which
   are to be used during surgical procedures.
 * A description of the packaging’s ability to maintain the device's sterility.
 * If sterilization involves ethylene oxide (EtO), the maximum levels of
   residues of ethylene oxide, ethylene chlorohydrin, and ethylene glycol which
   remain on the device. The levels should be consistent with the draft Federal
   Register Notice on EtO limits.
 * In the case of radiation sterilization, the radiation dose.


BIOCOMPATIBILITY INFORMATION FOR GOWNS

Surgical gowns are devices that are considered a surface-contacting device with
intact skin with a contact duration of ? 24 hours. The FDA recommends that
cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation or
intracutaneous reactivity (ISO 10993-10) is evaluated for a device. For more
information about biocompatibility end point assessment, please refer to the
final guidance document entitled, “Use of International Standard ISO 10993-1,
“Biological evaluation of medical devices - Part 1: Evaluation and testing
within a risk management process".

--------------------------------------------------------------------------------




BE INFORMED

You can sign up for our newsletter to be informed
about innovations about Bodygard.



Our disposable coveralls are used in painters suit, disposable chemical
protection suits, ebola protection kits, swine flue protection coveralls, ebola
coveralls and many more protection applications.

HALPFULL LINKS

 * About Us
 * Produscts
 * Blog
 * Contact
 * E-Store

TECHNOLOGY

 * Coverall Standards
 * Size Table
 * Fabric Performance
 * Industrial Info
 * F.A.Q

CONTACT US

Organize Sanayi Bölgesi 26. Cad. No:9 Eskişehir/Türkiye

Phone: +90 222 236 23 63
E-Mail: info@bodygard.com.tr



Copyright © 2016 - 2021 Bodygard.

ASD




ORIGINAL TEXT


Contribute a better translation

--------------------------------------------------------------------------------