Disposable Surgical Isolation Gown

Gown, Isolation, Surgical

Crown Name Disposable Hygiene Products Fty.Ltd.

The following data is part of a premarket notification filed by Crown Name Disposable Hygiene Products Fty.ltd. with the FDA for Disposable Surgical Isolation Gown.

Pre-market Notification Details

Device IDK212422
510k NumberK212422
Device Name:Disposable Surgical Isolation Gown
ClassificationGown, Isolation, Surgical
Applicant Crown Name Disposable Hygiene Products Fty.Ltd. Chengbei Industrial Zone,Zhucheng Ave,Xinzhou District Wuhan,  CN 431400
ContactYing Fang
CorrespondentDoris Chen
Shanghai Jiushun Enterprise Management Technology Service Co Room 1502,BaoAn Buiding,No.800 Dongfang Road Shanghai,  CN 200122
Product CodeFYC  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-04
Decision Date2022-04-29

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