510(k) K231908

45 Micron Polyisoprene Condom by Suretex Limited — Product Code MOL

K231908 is an FDA 510(k) premarket notification submitted by Suretex Limited for the device "45 Micron Polyisoprene Condom". The FDA issued a decision of Substantially Equivalent on October 27, 2023. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Suretex Limited has at least 5 other 510(k) clearances on record.