510(k) K241617

Durex Polyisoprene Condom by Rb Health (Us), LLC — Product Code MOL

K241617 is an FDA 510(k) premarket notification submitted by Rb Health (Us), LLC for the device "Durex Polyisoprene Condom". The FDA issued a decision of Substantially Equivalent on February 28, 2025. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Rb Health (Us), LLC has at least 10 other 510(k) clearances on record.