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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 K163267
Device Name NITRILE EXAMINATION GLOVE
Applicant
BRIGHTWAY HOLDINGS SDN BHD
LOT 1559, JALAN ISTIMEWA, BATU BELAH
KLANG,  MY 42100
Applicant Contact G. BASKARAN
Correspondent
BRIGHTWAY HOLDINGS SDN BHD
LOT 1559, JALAN ISTIMEWA, BATU BELAH
KLANG,  MY 42100
Correspondent Contact G. BASKARAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/21/2016
Decision Date 03/24/2017
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
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