510(k) K021076

PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM by Primeline Medical Products, Inc. — Product Code FXX

K021076 is an FDA 510(k) premarket notification submitted by Primeline Medical Products, Inc. for the device "PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM". The FDA issued a decision of Substantially Equivalent on April 16, 2002. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Primeline Medical Products, Inc. has at least 8 other 510(k) clearances on record.