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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 K990879
Device Name PRE POWDERED LATEX EXAMINATION GLOVES
Applicant
Apl Products Sdn. Bhd.
Lot 8961 & 8964
Jalan Benuas
Ayer Tawar,Perak Darul Ridzuan,  MY 32400
Applicant Contact SON HONG LEE
Correspondent
Apl Products Sdn. Bhd.
Lot 8961 & 8964
Jalan Benuas
Ayer Tawar,Perak Darul Ridzuan,  MY 32400
Correspondent Contact SON HONG LEE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/16/1999
Decision Date 05/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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