510(k) K213970

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply by Danameco Medical Joint Stock Corporation — Product Code FXX

K213970 is an FDA 510(k) premarket notification submitted by Danameco Medical Joint Stock Corporation for the device "D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply". The FDA issued a decision of Substantially Equivalent on Jan 23, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.