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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 K183132
Device Name Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
Applicant
O&M Halyard, Inc.
5405 Windward Pkwy.
Alpharetta,  GA  30004
Applicant Contact Angela L. Bunn
Correspondent
O&M Halyard, Inc.
5405 Windward Pkwy.
Alpharetta,  GA  30004
Correspondent Contact Angela L. Bunn
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Code
LZA  
Date Received11/13/2018
Decision Date 02/05/2019
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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