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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 K022878
Device Name BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)
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 Received08/30/2002
Decision Date 09/17/2002
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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