510(k) K230380

Surgical Face Masks, Model: EFMDS-L50Pn BLU by Iris USA — Product Code FXX

K230380 is an FDA 510(k) premarket notification submitted by Iris USA for the device "Surgical Face Masks, Model: EFMDS-L50Pn BLU". The FDA issued a decision of Substantially Equivalent on August 3, 2023. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.