510(k) K252521

LifeStyles® HydraFeel Natural Rubber Latex Condom by Suretex Limited — Product Code HIS

K252521 is an FDA 510(k) premarket notification submitted by Suretex Limited for the device "LifeStyles® HydraFeel Natural Rubber Latex Condom". The FDA issued a decision of Substantially Equivalent on November 18, 2025. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Suretex Limited has at least 5 other 510(k) clearances on record.