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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 K162113
Device Name Powder Free Nitrile Examination Gloves (Blue)
Applicant
Nam Viet Glove Joint Stock Company
Hamlet 7, Phuoc Binh Commune
Long Thanh District
Ho Chi Minh,  VN 815300
Applicant Contact OOI LOON SENG
Correspondent
Nam Viet Glove Joint Stock Company
Hamlet 7, Phuoc Binh Commune
Long Thanh District
Ho Chi Minh,  VN 815300
Correspondent Contact OOI LOON SENG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/29/2016
Decision Date 11/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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