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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name latex patient examination glove
510(k) Number K032938
Device Name BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER
Applicant
BRIGHTWAY HOLDINGS SDN. BHD.
LOT 1559, JALAN ISTIMEWA,
BATU BELAH
KLANG, SELANGOR,  MY 42100
Applicant Contact G. BASKARAN
Correspondent
BRIGHTWAY HOLDINGS SDN. BHD.
LOT 1559, JALAN ISTIMEWA,
BATU BELAH
KLANG, SELANGOR,  MY 42100
Correspondent Contact G. BASKARAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/22/2003
Decision Date 11/20/2003
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
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