Biodegradable Nitrile Examination Powder Free Glove, Green

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 Biodegradable Nitrile Examination Powder Free Glove, Green.

Pre-market Notification Details

Device IDK192111
510k NumberK192111
Device Name:Biodegradable Nitrile Examination Powder Free Glove, Green
ClassificationPolymer Patient Examination Glove
Applicant Top Glove SDN BHD Lot 4969, Jalan Teratai, Batu 6, Off Jalan Meru Klang,  MY 41050
ContactNoor Akilah 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 Received2019-08-05
Decision Date2020-09-03

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