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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 K955241
Device Name HIGH RISK GLOVES
Applicant
Pan-Century Rubber Products Sdn. Bhd.
Lot 230, Jalan Timah 2,
Pasir Gudang Industrial Estate
Pasir Gudang, Johor,  MY 81700
Applicant Contact P. SUNDARAM
Correspondent
Pan-Century Rubber Products Sdn. Bhd.
Lot 230, Jalan Timah 2,
Pasir Gudang Industrial Estate
Pasir Gudang, Johor,  MY 81700
Correspondent Contact P. SUNDARAM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/15/1995
Decision Date 05/28/1996
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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