510(k) K253398

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) by Efofex, Inc. — Product Code FXX

K253398 is an FDA 510(k) premarket notification submitted by Efofex, Inc. for the device "Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)". The FDA issued a decision of Substantially Equivalent on February 19, 2026. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Efofex, Inc. has at least 1 other 510(k) clearance on record.