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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 K153562
Device Name Powder Free Blue Nitrile Examination Glove
Applicant
Vietglove Corporation
Cau Sat Hamlet, Lai Hung Commune
Ben Cat District
Bau Bang Province,  VN
Applicant Contact Pham Ngoc Thanh
Correspondent
Vietglove Corporation
Cau Sat Hamlet, Lai Hung Commune
Ben Cat District
Bau Bang Province,  VN
Correspondent Contact Terence Lim
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/14/2015
Decision Date 04/01/2016
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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