Latex Examination Powder Free Glove, Aloe Vera

Polymer 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 Powder Free Glove, Aloe Vera.

Pre-market Notification Details

Device IDK193150
510k NumberK193150
Device Name:Latex Examination Powder Free Glove, Aloe Vera
ClassificationPolymer Patient Examination Glove
Applicant Top Glove SDN BHD Lot 4969, Jalan Teratai, Batu 6, Off Jalan Meru Klang,  MY 41050
ContactNoor Akilah Bt Saidin
CorrespondentDavid Lim
TG Medical (USA) Inc 165, North Aspan Avenue Azusa,  CA  91702
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-13
Decision Date2020-06-05

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