Medical Examination Gloves

Polymer Patient Examination Glove

Guangdong Gymda Medical Technology Co., Ltd

The following data is part of a premarket notification filed by Guangdong Gymda Medical Technology Co., Ltd with the FDA for Medical Examination Gloves.

Pre-market Notification Details

Device IDK212078
510k NumberK212078
Device Name:Medical Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant Guangdong Gymda Medical Technology Co., Ltd No.13, Quan'an Third Road, Phase 2 Of High-tech Zone Nanxiong,  CN 512400
ContactOlivia Chen
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-02
Decision Date2021-10-08

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