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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 K060402
Device Name BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)
Applicant
Brightway Holdings Sdn. Bhd.
Lot 1559, Jalan Istimewa,
Batu Belah
Klang, Selangor Darul Ehsan,  MY 42100
Applicant Contact G. BASKARAN
Correspondent
Brightway Holdings Sdn. Bhd.
Lot 1559, Jalan Istimewa,
Batu Belah
Klang, Selangor Darul Ehsan,  MY 42100
Correspondent Contact G. BASKARAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/15/2006
Decision Date 06/09/2006
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
Predetermined Change
Control Plan Authorized		 No
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