GREEN POWDERED LATEX EXAMINATION GLOVES

Latex Patient Examination Glove

TOP GLOVE SDN. BHD.

The following data is part of a premarket notification filed by Top Glove Sdn. Bhd. with the FDA for Green Powdered Latex Examination Gloves.

Pre-market Notification Details

Device IDK993452
510k NumberK993452
Device Name:GREEN POWDERED LATEX EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant TOP GLOVE SDN. BHD. LOT 4968, BT 6, JALAN TERATAI OFF JALAN MERU Klang, Selangor,  MY 41050
ContactT.s. Puon
CorrespondentT.s. Puon
TOP GLOVE SDN. BHD. LOT 4968, BT 6, JALAN TERATAI OFF JALAN MERU Klang, Selangor,  MY 41050
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-13
Decision Date1999-12-20

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