Powder Free Vinyl Examination Gloves

Vinyl Patient Examination Glove

Shanghai Shengda Medical Applications Co., Ltd

The following data is part of a premarket notification filed by Shanghai Shengda Medical Applications Co., Ltd with the FDA for Powder Free Vinyl Examination Gloves.

Pre-market Notification Details

Device IDK211103
510k NumberK211103
Device Name:Powder Free Vinyl Examination Gloves
ClassificationVinyl Patient Examination Glove
Applicant Shanghai Shengda Medical Applications Co., Ltd No. 608 Xingwen Road, North Development Zone, Jiading District Shanghai,  CN 201815
ContactYing Su
CorrespondentCharles Shen
Manton Business And Technology Services 37 Winding Ridge Oakland,  NJ  07436
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-13
Decision Date2021-11-04

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