510(k) K161915

Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant by Church & Dwight Co., Inc. — Product Code HIS

K161915 is an FDA 510(k) premarket notification submitted by Church & Dwight Co., Inc. for the device "Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant". The FDA issued a decision of Substantially Equivalent on September 9, 2016. 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.