510(k) K211249

Altor Safety 3-Ply Surgical Mask (Model:62222) by Altor Safety, LLC — Product Code FXX

K211249 is an FDA 510(k) premarket notification submitted by Altor Safety, LLC for the device "Altor Safety 3-Ply Surgical Mask (Model:62222)". The FDA issued a decision of Substantially Equivalent on Jul 23, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Altor Safety, LLC has 1 other 510(k) clearance on record.