510(k) K231005

Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 by Supermax Healthcare Canada-Supermax Medical — Product Code FXX

K231005 is an FDA 510(k) premarket notification submitted by Supermax Healthcare Canada-Supermax Medical for the device "Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2". The FDA issued a decision of Substantially Equivalent on December 5, 2023. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.