510(k) K210513

UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 by Universal Incorporation — Product Code FXX

K210513 is an FDA 510(k) premarket notification submitted by Universal Incorporation for the device "UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2". The FDA issued a decision of Substantially Equivalent on Sep 29, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.