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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 K163017
Device Name Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
Applicant
Gmp Medicare Sdn. Bhd.
Lot/Pt64593, Jln Dahlia/Ku8, Kaw Perindustrian Meru Timur
Klang,  MY 41050
Applicant Contact EVA VINONI BT MUSTAFA
Correspondent
Gmp Medicare Sdn. Bhd.
Lot/Pt64593, Jln Dahlia/Ku8, Kaw Perindustrian Meru Timur
Klang,  MY 41050
Correspondent Contact EVA VINONI BT MUSTAFA
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Code
LZA  
Date Received10/28/2016
Decision Date 03/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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