USA Gloves Nitrile Powder Free Exam Gloves

Polymer Patient Examination Glove

USA Gloves

The following data is part of a premarket notification filed by Usa Gloves with the FDA for Usa Gloves Nitrile Powder Free Exam Gloves.

Pre-market Notification Details

Device IDK211624
510k NumberK211624
Device Name:USA Gloves Nitrile Powder Free Exam Gloves
ClassificationPolymer Patient Examination Glove
Applicant USA Gloves 12505 Reed Rd Ste 110 Sugar Land,  TX  77478
ContactZishan Momin
CorrespondentZishan Momin
USA Gloves 12505 Reed Rd Ste 110 Sugar Land,  TX  77478
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-27
Decision Date2021-12-18

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