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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 K910045
Device Name PATIENT EXAMINATION GLOVES-POWDER FREED
Applicant
Pan-Century Rubber Products Sdn. Bhd.
Lot No 230, Jalan Timah 2,
Pasir Gudang Industrial Estate
81700 Johor, Malaysia,  ML
Applicant Contact PARAKH
Correspondent
Pan-Century Rubber Products Sdn. Bhd.
Lot No 230, Jalan Timah 2,
Pasir Gudang Industrial Estate
81700 Johor, Malaysia,  ML
Correspondent Contact PARAKH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/04/1991
Decision Date 01/15/1991
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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