Synthetic Vinyl Examination Gloves

Vinyl Patient Examination Glove

Jiangsu Huayuan Medical Technology Co., Ltd.

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

Pre-market Notification Details

Device IDK211045
510k NumberK211045
Device Name:Synthetic Vinyl Examination Gloves
ClassificationVinyl Patient Examination Glove
Applicant Jiangsu Huayuan Medical Technology Co., Ltd. No. 36 Nanzhuang Road, High-Tech Industrial Development Zone Of Dongtai City Dongtai,  CN 224299
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 Received2021-04-08
Decision Date2021-06-23

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