510(k) K202096

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On by Ecoguard, Inc. — Product Code FXX

K202096 is an FDA 510(k) premarket notification submitted by Ecoguard, Inc. for the device "3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On". The FDA issued a decision of Substantially Equivalent on Feb 2, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.