510(k) K252158

Sagami Original 002 Polyurethane Male Condom by Mayer Laboratories — Product Code MOL

K252158 is an FDA 510(k) premarket notification submitted by Mayer Laboratories for the device "Sagami Original 002 Polyurethane Male Condom". The FDA issued a decision of Substantially Equivalent on March 30, 2026. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Mayer Laboratories has at least 10 other 510(k) clearances on record.