Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask

Mask, Surgical

Xiantao S&J Protective Products Co., Ltd.

The following data is part of a premarket notification filed by Xiantao S&j Protective Products Co., Ltd. with the FDA for Disposable Ear-loop Medical Face Mask, Disposable Tie-on Medical Face Mask.

Pre-market Notification Details

Device IDK211462
510k NumberK211462
Device Name:Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask
ClassificationMask, Surgical
Applicant Xiantao S&J Protective Products Co., Ltd. 103 Mianyang Road Xiantao,  CN 433000
ContactDove Wei
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. BOX 120-119 Shanghai,  CN 200120
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-11
Decision Date2021-08-19

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