Vinyl Patient Examination Gloves

Vinyl Patient Examination Glove

Jiangxi Shengda Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Jiangxi Shengda Medical Technology Co., Ltd. with the FDA for Vinyl Patient Examination Gloves.

Pre-market Notification Details

Device IDK211239
510k NumberK211239
Device Name:Vinyl Patient Examination Gloves
ClassificationVinyl Patient Examination Glove
Applicant Jiangxi Shengda Medical Technology Co., Ltd. No.25 Factory, Wencheng Block, High-tech Zone, Yushan County Shangrao,  CN 334711
ContactYun Gao
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-26
Decision Date2021-07-17

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