510(k) K252964

PRIMED Surgical and Procedure Masks by Primed Medical Products, Inc. — Product Code FXX

K252964 is an FDA 510(k) premarket notification submitted by Primed Medical Products, Inc. for the device "PRIMED Surgical and Procedure Masks". The FDA issued a decision of Substantially Equivalent on November 4, 2025. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Primed Medical Products, Inc. has at least 7 other 510(k) clearances on record.