Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Polymer Patient Examination Glove
510(k) Number K220547
Device Name PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
Applicant
O&M Halyard, Inc.
1 Edison Dr.
Alpharetta,  GA  30005
Applicant Contact Angela L. Bunn
Correspondent
O&M Halyard, Inc.
1 Edison Dr.
Alpharetta,  GA  30005
Correspondent Contact Angela L. Bunn
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   QDO  
Date Received02/25/2022
Decision Date 06/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-