Surgical Face Mask

Mask, Surgical

Sunsmed Protective Products Ltd.

The following data is part of a premarket notification filed by Sunsmed Protective Products Ltd. with the FDA for Surgical Face Mask.

Pre-market Notification Details

Device IDK211296
510k NumberK211296
Device Name:Surgical Face Mask
ClassificationMask, Surgical
Applicant Sunsmed Protective Products Ltd. No.18, Industrial Park, Maozui Town Xinatao,  CN 433000
ContactJoyce Lee
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-28
Decision Date2021-09-11

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