Disposable Medical Mask

Mask, Surgical

Hangzhou Qianzhiya Sanitary Products Co., Ltd

The following data is part of a premarket notification filed by Hangzhou Qianzhiya Sanitary Products Co., Ltd with the FDA for Disposable Medical Mask.

Pre-market Notification Details

Device IDK202133
510k NumberK202133
Device Name:Disposable Medical Mask
ClassificationMask, Surgical
Applicant Hangzhou Qianzhiya Sanitary Products Co., Ltd No.88 Fengwang Road, Economic Development Zone Tonglu, Tonglu County Hangzhou,  CN 311500
ContactYu Shao
CorrespondentIvy Wang
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 Received2020-07-31
Decision Date2021-03-25

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