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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 K151208
Device Name Powder Free Nitrile Examination Glove
Applicant
Vrg Khai Hoan Joint Stock Company
Cau Sat Hamlet, Lai Hung Commune
Ben Cat District,,  VN
Applicant Contact PHAM NGOC THANH
Correspondent
Vrg Khai Hoan Joint Stock Company
Cau Sat Hamlet, Lai Hung Commune
Ben Cat District,,  VN
Correspondent Contact TERENCE LIM
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/06/2015
Decision Date 09/14/2015
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
Recalls CDRH Recalls
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