Surgical Face Mask

Mask, Surgical

Zhongshan Saifute Labor Protective Articles CO., LTD

The following data is part of a premarket notification filed by Zhongshan Saifute Labor Protective Articles Co., Ltd with the FDA for Surgical Face Mask.

Pre-market Notification Details

Device IDK212059
510k NumberK212059
Device Name:Surgical Face Mask
ClassificationMask, Surgical
Applicant Zhongshan Saifute Labor Protective Articles CO., LTD No.7, Xihuan 4th Road, Southern District Zhongshan,  CN 528400
ContactQionghua Ke
CorrespondentQionghua Ke
Zhongshan Saifute Labor Protective Articles CO., LTD No.7, Xihuan 4th Road, Southern District Zhongshan,  CN 528400
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-01
Decision Date2021-12-17

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