Surgical Gowns

Gown, Surgical

Jiangsu Province Jianerkang Medical Dressing Co., Ltd

The following data is part of a premarket notification filed by Jiangsu Province Jianerkang Medical Dressing Co., Ltd with the FDA for Surgical Gowns.

Pre-market Notification Details

Device IDK210215
510k NumberK210215
Device Name:Surgical Gowns
ClassificationGown, Surgical
Applicant Jiangsu Province Jianerkang Medical Dressing Co., Ltd No.1 Jianerkang Road, Zhixi Industry Concentration Area, Zhixi Town Changzhou,  CN 213251
ContactTang Hongfang
CorrespondentTang Hongfang
Jiangsu Province Jianerkang Medical Dressing Co., Ltd No.1 Jianerkang Road, Zhixi Industry Concentration Area, Zhixi Town Changzhou,  CN 213251
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-27
Decision Date2021-07-07

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.