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 K182096
Device Name Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs
Applicant
Owens & Minor Halyard, Inc.
5405 Windward Pkwy.
Alpharetta,  GA  30004
Applicant Contact Angela L. Bunn
Correspondent
Owens & Minor Halyard, Inc.
5405 Windward Pkwy.
Alpharetta,  GA  30004
Correspondent Contact Angela L. Bunn
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received08/03/2018
Decision Date 11/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-