Disposable Surgical Face Mask

Mask, Surgical

Jiangsu NewValue Medical Products Co., Ltd.

The following data is part of a premarket notification filed by Jiangsu Newvalue Medical Products Co., Ltd. with the FDA for Disposable Surgical Face Mask.

Pre-market Notification Details

Device IDK202491
510k NumberK202491
Device Name:Disposable Surgical Face Mask
ClassificationMask, Surgical
Applicant Jiangsu NewValue Medical Products Co., Ltd. Building G35, No. I Avenue, China Medical City Taizhou,  CN 225300
ContactZhou Zhengguo
CorrespondentJulie Chen
Shanghai Medical Business Consulting Co., Ltd. Room 304, No 170 Huajiang Road, Jiading District Shanghai,  CN 201803
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-31
Decision Date2021-01-06

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