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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 K180646
Device Name Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
Applicant
Halyard Health
5405 Windward Pkwy.
Alpharetta,  GA  30004
Applicant Contact Christine L. Macauley
Correspondent
Halyard Health
5405 Windward Pkwy.
Alpharetta,  GA  30004
Correspondent Contact Christine L. Macauley
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Code
LZA  
Date Received03/12/2018
Decision Date 06/27/2018
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
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