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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 K152222
Device Name NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs
Applicant
Gmp Medicare Sdn Bhd (F25)
Lot/Pt64593,Jln Dahlia/Ku8,Kaw Perindustrian Meru Timur
Klang,  MY 41050
Applicant Contact MS.EVA VINONI MUSTAFA
Correspondent
Gmp Medicare Sdn Bhd (F25)
Lot/Pt64593,Jln Dahlia/Ku8,Kaw Perindustrian Meru Timur
Klang,  MY 41050
Correspondent Contact MS.EVA VINONI MUSTAFA
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Code
LZA  
Date Received08/07/2015
Decision Date 04/21/2016
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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