Surgical Isolation Cover Gown

Gown, Isolation, Surgical

Wuhan Dymex Healthcare Co., Ltd.

The following data is part of a premarket notification filed by Wuhan Dymex Healthcare Co., Ltd. with the FDA for Surgical Isolation Cover Gown.

Pre-market Notification Details

Device IDK220528
510k NumberK220528
Device Name:Surgical Isolation Cover Gown
ClassificationGown, Isolation, Surgical
Applicant Wuhan Dymex Healthcare Co., Ltd. Room 1701, Unit 2, Building 5, Jinsegangwan Phase 5, Dongfeng Avenue Wuhan,  CN 430000
ContactLynn Wu
CorrespondentDiana Hong
Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai,  CN 200120
Product CodeFYC  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-24
Decision Date2022-06-10

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