Polymer Patient Examination Glove

AT Glove Engineering SDN. BHD

The following data is part of a premarket notification filed by At Glove Engineering Sdn. Bhd with the FDA for At.

Pre-market Notification Details

Device IDK212645
510k NumberK212645
Device Name:AT
ClassificationPolymer Patient Examination Glove
Applicant AT Glove Engineering SDN. BHD No. 9, Jalan Chepor 11/7 Kawasan Perusahaan Seramik Chepor,  MY 31200
ContactL. A. Choong
CorrespondentManoj Zacharias
Liberty Management Group Limited 75 Executive Drive Suite 114 Aurora,  IL  60504
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-20
Decision Date2021-12-16

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