510(k) K252650

Disposable Medical Face Mask by Makrite Industries, Inc. — Product Code FXX

K252650 is an FDA 510(k) premarket notification submitted by Makrite Industries, Inc. for the device "Disposable Medical Face Mask". The FDA issued a decision of Substantially Equivalent on January 5, 2026. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Makrite Industries, Inc. has at least 3 other 510(k) clearances on record.