1st Glove Blue Nitrile Examination Gloves Powder Free

Polymer Patient Examination Glove

Koove Iot Pvt. Ltd.

The following data is part of a premarket notification filed by Koove Iot Pvt. Ltd. with the FDA for 1st Glove Blue Nitrile Examination Gloves Powder Free.

Pre-market Notification Details

Device IDK221226
510k NumberK221226
Device Name:1st Glove Blue Nitrile Examination Gloves Powder Free
ClassificationPolymer Patient Examination Glove
Applicant Koove Iot Pvt. Ltd. Gokulpur, PO:Shyamraipur Paschim Midnapur,  IN 721305
ContactSudarsan Mohapatra
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 Received2022-04-28
Decision Date2022-06-16

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