Disposable Surgical Face Mask

Mask, Surgical

Xiantao Zhongyi Safety & Protection Products Co., Ltd

The following data is part of a premarket notification filed by Xiantao Zhongyi Safety & Protection Products Co., Ltd with the FDA for Disposable Surgical Face Mask.

Pre-market Notification Details

Device IDK203685
510k NumberK203685
Device Name:Disposable Surgical Face Mask
ClassificationMask, Surgical
Applicant Xiantao Zhongyi Safety & Protection Products Co., Ltd No.101, Xianyuan Road Xiantao,  CN 433000
ContactYang Xi
CorrespondentMandy Wu
Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-17
Decision Date2021-03-26

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