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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 K102880
Device Name BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR)
Applicant
BRIGHTWAY HOLDINGS SDN. BHD.
LOT 1559, JALAN ISTIMEWA,
BATU BELAH
KLANG, SELANGOR,  MY 42100
Applicant Contact NADARAJAN VENUGOPAL
Correspondent
BRIGHTWAY HOLDINGS SDN. BHD.
LOT 1559, JALAN ISTIMEWA,
BATU BELAH
KLANG, SELANGOR,  MY 42100
Correspondent Contact NADARAJAN VENUGOPAL
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/30/2010
Decision Date 11/19/2010
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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