510(k) K221431

TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant by Church & Dwight Co., Inc. — Product Code HIS

K221431 is an FDA 510(k) premarket notification submitted by Church & Dwight Co., Inc. for the device "TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant". The FDA issued a decision of Substantially Equivalent on July 14, 2022. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Church & Dwight Co., Inc. has at least 10 other 510(k) clearances on record.