K-number	K210433
Device name	Surgical Face Mask (Ear loops and Tie-on)
Applicant	Wuhan Dymex Healthcare Co., Ltd.
Product code	FXX
Device class	Class II
Decision date	Jun 7, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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View the full FDA submission: accessdata.fda.gov

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Surgical Face Mask (Ear loops and Tie-on)

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