510(k) K251902

Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) by Vitacore Industries, Inc. — Product Code FXX

K251902 is an FDA 510(k) premarket notification submitted by Vitacore Industries, Inc. for the device "Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)". The FDA issued a decision of Substantially Equivalent on September 17, 2025. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.