510(k) K182438

Synthetic Polyisoprene Lubricated Male Condom - 5 senses by Sxwell USA, LLC — Product Code MOL

K182438 is an FDA 510(k) premarket notification submitted by Sxwell USA, LLC for the device "Synthetic Polyisoprene Lubricated Male Condom - 5 senses". The FDA issued a decision of Substantially Equivalent on December 6, 2018. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Sxwell USA, LLC has at least 1 other 510(k) clearance on record.