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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K213929
Device Name Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
Applicant
O&M Halyard, Inc.
1 Edison Dr.
Alpharetta,  GA  30005
Applicant Contact Steven Dowdley
Correspondent
O&M Halyard, Inc.
9120 Lockwood Blvd.
Mechanicsville,  VA  23116
Correspondent Contact Angela L. Bunn
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
OPJ   QDO  
Date Received12/16/2021
Decision Date 08/01/2022
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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