510(k) K230569

Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) by Cardinalhealth — Product Code FXX

K230569 is an FDA 510(k) premarket notification submitted by Cardinalhealth for the device "Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )". The FDA issued a decision of Substantially Equivalent on July 3, 2023. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Cardinalhealth has at least 10 other 510(k) clearances on record.