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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 K991752
Device Name BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE
Applicant
Brightsway Holdings Sdn Bhd
Batu Belah
Klang Selangor Darul Ehsan,  MY 42100
Applicant Contact G. BASKARAN
Correspondent
Brightsway Holdings Sdn Bhd
Batu Belah
Klang Selangor Darul Ehsan,  MY 42100
Correspondent Contact G. BASKARAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/24/1999
Decision Date 06/23/1999
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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