Goody Gloves, Wincare, TBG Gloves

Latex Patient Examination Glove

Thai Rubber Gloves Co., Ltd

The following data is part of a premarket notification filed by Thai Rubber Gloves Co., Ltd with the FDA for Goody Gloves, Wincare, Tbg Gloves.

Pre-market Notification Details

Device IDK213073
510k NumberK213073
Device Name:Goody Gloves, Wincare, TBG Gloves
ClassificationLatex Patient Examination Glove
Applicant Thai Rubber Gloves Co., Ltd 680 Moo 2 Banbueng-Klaeng Rd. Nongyai,  TH 20190
ContactChalongkwan Wongsasuthikul
CorrespondentManoj Zacharias
Liberty Management Group Ltd. 75 Executive Dr. STE 114, Aurora,  IL  60504
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-23
Decision Date2021-12-29

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