K-number	K220194
Device name	Procedure mask/Surgical mask/Face mask
Applicant	Winner Medical Co., Ltd.
Product code	FXX
Device class	Class II
Decision date	May 17, 2022
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Procedure mask/Surgical mask/Face mask

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