Surgical Face Mask (Non-sterile)

Mask, Surgical

Hubei Kimsoul Industrial Co., Ltd

The following data is part of a premarket notification filed by Hubei Kimsoul Industrial Co., Ltd with the FDA for Surgical Face Mask (non-sterile).

Pre-market Notification Details

Device IDK212398
510k NumberK212398
Device Name:Surgical Face Mask (Non-sterile)
ClassificationMask, Surgical
Applicant Hubei Kimsoul Industrial Co., Ltd NO. 1, Industrial Zone, Guohe Town Xiantao,  CN 433013
ContactFaming Zhang
CorrespondentGrace Liu
Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen,  CN 518000
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-02
Decision Date2021-12-15

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