urlscan.io logo urlscan.io
SecurityTrails logo

www.accessdata.fda.gov Open in urlscan Pro
2a02:26f0:6c00:280::2e60  Public Scan

Back to summary
URL: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K210496
Submission: On June 21 via manual from US — Scanned from DE

Form analysis 1 forms found in the DOM

GET https://search.fda.gov/search

<form id="search_form" action="https://search.fda.gov/search" accept-charset="UTF-8" method="get">
  <input name="utf8" type="hidden" value="✓">
  <input type="hidden" name="affiliate" id="affiliate" value="fda1">
  <label class="searchlable" for="query">Search FDA</label>
  <input accesskey="4" type="text" name="query" id="query" autocomplete="off" class="usagov-search-autocomplete ui-autocomplete-input">
  <div id="go_button" style="left:150px">
    <a href="javascript:document.getElementById('search_form').submit();" title="Search this site"><img src="/scripts/includes/images/img_fdagov_mast_search_button.png" alt="Search" title="Search this site"></a>
  </div>
</form>

Text Content

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip
to Common Links
 * 
 * 
 * 


U.S. Food & Drug Administration
 
 * Follow FDA
 * En Español

Search FDA

 
 * Home
 * Food
 * Drugs
 * Medical Devices
 * Radiation-Emitting Products
 * Vaccines, Blood & Biologics
 * Animal & Veterinary
 * Cosmetics
 * Tobacco Products

 


510(K) PREMARKET NOTIFICATION

 * 
 * 1
 * 2

 * FDA Home3
 * Medical Devices4
 * Databases5

-

6

510(k)7 | DeNovo8 | Registration & Listing9 | Adverse Events10 | Recalls11 |
PMA12 | HDE13 | Classification14 | Standards15

CFR Title 2116 | Radiation-Emitting Products17 | X-Ray Assembler18 | Medsun
Reports19 | CLIA20 | TPLC21

 



New Search Back To Search Results

Device Classification Name polymer patient examination glove22 510(k) Number
K210496 Device Name Nautilus Nitrile Exam Gloves Applicant

Nautilus Gloves LLC 767 5th Avenue 15th Floor Manhattan,  NY  10153

Applicant Contact Mesh Gelman Correspondent

Nautilus Gloves LLC 767 5th Avenue 15th Floor Manhattan,  NY  10153

Correspondent Contact Mesh Gelman Regulation Number880.625023 Classification
Product Code

LZA24  

Date Received02/22/2021 Decision Date 05/26/2021 Decision Substantially
Equivalent (SESE) Regulation Medical Specialty General Hospital 510k Review
Panel General Hospital Summary Summary25 Type Abbreviated Reviewed by Third
Party No Combination Product No

-
-

LINKS ON THIS PAGE:

 1.  http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
 2.  http://www.addthis.com/bookmark.php
 3.  https://www.fda.gov/
 4.  https://www.fda.gov/Medical-Devices
 5.  https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
 6.  /scripts/cdrh/devicesatfda/index.cfm
 7.  /scripts/cdrh/cfdocs/cfPMN/pmn.cfm
 8.  /scripts/cdrh/cfdocs/cfpmn/denovo.cfm
 9.  /scripts/cdrh/cfdocs/cfRL/rl.cfm
 10. /scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
 11. /scripts/cdrh/cfdocs/cfRES/res.cfm
 12. /scripts/cdrh/cfdocs/cfPMA/pma.cfm
 13. /scripts/cdrh/cfdocs/cfHDE/hde.cfm
 14. /scripts/cdrh/cfdocs/cfPCD/classification.cfm
 15. /scripts/cdrh/cfdocs/cfStandards/search.cfm
 16. /scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
 17. /scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm
 18. /scripts/cdrh/cfdocs/cfAssem/assembler.cfm
 19. /scripts/cdrh/cfdocs/Medsun/searchReportText.cfm
 20. /scripts/cdrh/cfdocs/cfClia/Search.cfm
 21. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm
 22. /scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&productcode=LZA
 23. /scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.6250
 24. /scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&productcode=LZA
 25. https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210496.pdf

Page Last Updated: 06/20/2022

Note: If you need help accessing information in different file formats, see
Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog |
Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano |
Deutsch | 日本語 | فارسی | English


 * Accessibility
 * Contact FDA
 * Careers
 * FDA Basics
 * FOIA
 * No FEAR Act
 * Nondiscrimination
 * Website Policies / Privacy


U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Contact FDA
 * 
 * 
 * 
 * 
 * 
 * 
 * 

 * For Government
 * For Press

 * Combination Products
 * Advisory Committees
 * Science & Research
 * Regulatory Information
 * Safety
 * Emergency Preparedness
 * International Programs
 * News & Events
 * Training and Continuing Education
 * Inspections/Compliance
 * State & Local Officials
 * Consumers
 * Industry
 * Health Professionals
 * FDA Archive


 

LINKS ON THIS PAGE:

 1.  http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
 2.  http://www.addthis.com/bookmark.php
 3.  https://www.fda.gov/
 4.  https://www.fda.gov/Medical-Devices
 5.  https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
 6.  /scripts/cdrh/devicesatfda/index.cfm
 7.  /scripts/cdrh/cfdocs/cfPMN/pmn.cfm
 8.  /scripts/cdrh/cfdocs/cfpmn/denovo.cfm
 9.  /scripts/cdrh/cfdocs/cfRL/rl.cfm
 10. /scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
 11. /scripts/cdrh/cfdocs/cfRES/res.cfm
 12. /scripts/cdrh/cfdocs/cfPMA/pma.cfm
 13. /scripts/cdrh/cfdocs/cfHDE/hde.cfm
 14. /scripts/cdrh/cfdocs/cfPCD/classification.cfm
 15. /scripts/cdrh/cfdocs/cfStandards/search.cfm
 16. /scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
 17. /scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm
 18. /scripts/cdrh/cfdocs/cfAssem/assembler.cfm
 19. /scripts/cdrh/cfdocs/Medsun/searchReportText.cfm
 20. /scripts/cdrh/cfdocs/cfClia/Search.cfm
 21. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm
 22. /scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&productcode=LZA
 23. /scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.6250
 24. /scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&productcode=LZA
 25. https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210496.pdf