510(k) K203541

Okamoto 002 Lubricated Polyurethane Male Condom by Okamoto USA, Inc. — Product Code MOL

K203541 is an FDA 510(k) premarket notification submitted by Okamoto USA, Inc. for the device "Okamoto 002 Lubricated Polyurethane Male Condom". The FDA issued a decision of Substantially Equivalent on February 25, 2022. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Okamoto USA, Inc. has at least 10 other 510(k) clearances on record.