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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K200633
Device Name Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
Applicant
0 & M Halyard, Inc.
5405 Windward Pkwy.
Alpharetta,  GA  30004
Applicant Contact Steven Dowdley
Correspondent
0 & M Halyard, Inc.
5405 Windward Pkwy.
Alpharetta,  GA  30004
Correspondent Contact Steven Dowdley
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Codes
LZA   QDO  
Date Received03/10/2020
Decision Date 10/11/2020
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
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