510(k) K242502

Aurelia Surgical Mask ASTM Level-3 (2130) by Supermax Healthcare Canada – Supermax Medical — Product Code FXX

K242502 is an FDA 510(k) premarket notification submitted by Supermax Healthcare Canada – Supermax Medical for the device "Aurelia Surgical Mask ASTM Level-3 (2130)". The FDA issued a decision of Substantially Equivalent on November 12, 2024. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.