510(k) K240379

TROJAN SIS Synthetic Latex Condom with Silicone Lubricant by Church & Dwight Co., Inc. — Product Code MOL

K240379 is an FDA 510(k) premarket notification submitted by Church & Dwight Co., Inc. for the device "TROJAN SIS Synthetic Latex Condom with Silicone Lubricant". The FDA issued a decision of Substantially Equivalent on October 8, 2024. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Church & Dwight Co., Inc. has at least 10 other 510(k) clearances on record.