TC Gloves

Polymer Patient Examination Glove

Thanh Cong Pharmaceutical And Trading Company Limited

The following data is part of a premarket notification filed by Thanh Cong Pharmaceutical And Trading Company Limited with the FDA for Tc Gloves.

Pre-market Notification Details

Device IDK221186
510k NumberK221186
Device Name:TC Gloves
ClassificationPolymer Patient Examination Glove
Applicant Thanh Cong Pharmaceutical And Trading Company Limited KM6+ 200 National Road No. 38, Hap Linh Bac Ninh City,  VN
ContactNguyen Thi Tu Anh
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 Received2022-04-25
Decision Date2022-06-16

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