Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)

Polymer Patient Examination Glove

Ammex Corporation

The following data is part of a premarket notification filed by Ammex Corporation with the FDA for Powder Free Nitrile Examination Gloves (blue, Black, Indigo).

Pre-market Notification Details

Device IDK211457
510k NumberK211457
Device Name:Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)
ClassificationPolymer Patient Examination Glove
Applicant Ammex Corporation 1019 W James St, Suite 200 Kent,  WA  98032
ContactSasitharan Nair
CorrespondentDavendran Tangaya
Ammex Corporation 1019 W James St, Suite 200 Kent,  WA  98032
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-11
Decision Date2021-12-18

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.