510(k) K202595

Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask by Premier Guard USA, LLC — Product Code FXX

K202595 is an FDA 510(k) premarket notification submitted by Premier Guard USA, LLC for the device "Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask". The FDA issued a decision of Substantially Equivalent on Jan 21, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.