510(k) K212740

Puravita Medical Fold Flat Surgical Mask by Puravita M, LLC — Product Code FXX

K212740 is an FDA 510(k) premarket notification submitted by Puravita M, LLC for the device "Puravita Medical Fold Flat Surgical Mask". The FDA issued a decision of Substantially Equivalent on Dec 2, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.