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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K992020
Device Name BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)
Applicant
Brightsway Holdings Sdn Bhd
Lot 1559, Jalan Istimewa,
Batu Belah
Klang, Selangor Darul Ehsan,  MY 42100
Applicant Contact G. BASKARAN
Correspondent
Brightsway Holdings Sdn Bhd
Lot 1559, Jalan Istimewa,
Batu Belah
Klang, Selangor Darul Ehsan,  MY 42100
Correspondent Contact G. BASKARAN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received06/16/1999
Decision Date 07/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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