K-number	K202595
Device name	Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask
Applicant	Premier Guard USA, LLC
Product code	FXX
Device class	Class II
Decision date	Jan 21, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask

Everything you need for a 510(k) submission. Nothing you don't.