K-number	K221134
Device name	Procedure Mask with Ear Loops and Surgical Mask with Ties
Applicant	Safesource Direct, LLC
Product code	FXX
Device class	Class II
Decision date	May 19, 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 with Ear Loops and Surgical Mask with Ties

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