Glovmaster Nitrile Examination Glove Powder Free

Polymer Patient Examination Glove

Glovmaster SDN. BHD.

The following data is part of a premarket notification filed by Glovmaster Sdn. Bhd. with the FDA for Glovmaster Nitrile Examination Glove Powder Free.

Pre-market Notification Details

Device IDK212914
510k NumberK212914
Device Name:Glovmaster Nitrile Examination Glove Powder Free
ClassificationPolymer Patient Examination Glove
Applicant Glovmaster SDN. BHD. 154, Jalan 4, Kawasan Perindustrian Olak Lempit Banting,  MY 42700
ContactZarina Binti Hamid
CorrespondentManoj Zacharias
Liberty Management Group Limited 75 Executive Drive Suite 114 Aurora,  IL  60504
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-13
Decision Date2021-12-22

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