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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 K993495
Device Name POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS)
Applicant
Besglove Medicare Sdn. Bhd.
Lot 6, Jalan P/2a
Bangi Industrial Estate
Kajang,Selangor Darul,Ehasan,  MY 43000
Applicant Contact LEE AIK LIM
Correspondent
Besglove Medicare Sdn. Bhd.
Lot 6, Jalan P/2a
Bangi Industrial Estate
Kajang,Selangor Darul,Ehasan,  MY 43000
Correspondent Contact LEE AIK LIM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/15/1999
Decision Date 11/24/1999
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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