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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 K153708
Device Name Halyard Black-Orange Powder-Free Nitrile Exam Glove
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
LZA  
Date Received12/23/2015
Decision Date 03/31/2016
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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