Blue Nitrile Examination Gloves Powder Free

Polymer Patient Examination Glove

Amazing Rubber Products Pvt Ltd

The following data is part of a premarket notification filed by Amazing Rubber Products Pvt Ltd with the FDA for Blue Nitrile Examination Gloves Powder Free.

Pre-market Notification Details

Device IDK212584
510k NumberK212584
Device Name:Blue Nitrile Examination Gloves Powder Free
ClassificationPolymer Patient Examination Glove
Applicant Amazing Rubber Products Pvt Ltd Plot No 14c, Cochin Special Economic Zone Cochin,  IN 682037
ContactJayasankar S
CorrespondentManoj Zacharias
Liberty Management Group Ltd. 75 Executive Dr. STE114 Aurora,  IL  60504
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-16
Decision Date2022-05-28

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