Disposable Medical Face Mask (ear Loop)

Mask, 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 Medical Face Mask (ear Loop).

Pre-market Notification Details

Device IDK221196
510k NumberK221196
Device Name:Disposable Medical Face Mask (ear Loop)
ClassificationMask, 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 CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-25
Decision Date2022-07-22

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