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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 K172867
Device Name Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange
Applicant
Gmp Medicare Sdn Bhd (F25)
Lot/Pt64593, Jln Dahlia/Ku8, Kaw Perindustrian Meru Timur
Klang,  MY 41050
Applicant Contact Noraini Raus
Correspondent
Gmp Medicare Sdn Bhd (F25)
Lot/Pt64593, Jln Dahlia/Ku8, Kaw Perindustrian Meru Timur
Klang,  MY 41050
Correspondent Contact Noraini Raus
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/20/2017
Decision Date 05/10/2018
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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