Disposable Medical Face Mask

Mask, Surgical

Qinghai Zhong Dao Win-win Medical Protective Equipment Co.,

The following data is part of a premarket notification filed by Qinghai Zhong Dao Win-win Medical Protective Equipment Co., with the FDA for Disposable Medical Face Mask.

Pre-market Notification Details

Device IDK202628
510k NumberK202628
Device Name:Disposable Medical Face Mask
ClassificationMask, Surgical
Applicant Qinghai Zhong Dao Win-win Medical Protective Equipment Co., No.36 Jingsan Road, Biological Park Xining,  CN 810000
ContactZhaochu Chen
CorrespondentShelley Li
Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai,  CN 200071
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-11
Decision Date2021-03-19

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