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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 K020865
Device Name ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
Applicant
Apl Products Sdn. Bhd.
Lot 8961 & 8964
Jalan Benuas
Ayer Tawar,Perak Darul Ridzuan,  MY 32400
Applicant Contact LEE SON HONG
Correspondent
Apl Products Sdn. Bhd.
Lot 8961 & 8964
Jalan Benuas
Ayer Tawar,Perak Darul Ridzuan,  MY 32400
Correspondent Contact LEE SON HONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/18/2002
Decision Date 05/08/2002
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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