Disposable Surgical Gown (G4003)

Gown, Surgical

Xiantao Topmed Nonwoven Protective Products Co., Ltd.

The following data is part of a premarket notification filed by Xiantao Topmed Nonwoven Protective Products Co., Ltd. with the FDA for Disposable Surgical Gown (g4003).

Pre-market Notification Details

Device IDK221977
510k NumberK221977
Device Name:Disposable Surgical Gown (G4003)
ClassificationGown, Surgical
Applicant Xiantao Topmed Nonwoven Protective Products Co., Ltd. North Of The National Road 318, Tongjiazui Village,Huchang Town Xiantao,  CN 433000
ContactVivian Zhu
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai,  CN 200122
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-05
Decision Date2022-10-20

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