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 Latex Examination Gloves.

Pre-market Notification Details

Device IDK913409
510k NumberK913409
Device Name:LATEX EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant TOP GLOVE SDN. BHD. 24, JALAN RAJA MOKHTAR DUA 42200 KAPAR, SELANGOR D.E. Malaysia,  ML
ContactBee Tong
CorrespondentBee Tong
TOP GLOVE SDN. BHD. 24, JALAN RAJA MOKHTAR DUA 42200 KAPAR, SELANGOR D.E. Malaysia,  ML
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-30
Decision Date1991-09-27

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