510(k) K163107

Lifestyles Zero Lubricated Latex Male Condom by Ansell Healthcare Products, LLC — Product Code HIS

K163107 is an FDA 510(k) premarket notification submitted by Ansell Healthcare Products, LLC for the device "Lifestyles Zero Lubricated Latex Male Condom". The FDA issued a decision of Substantially Equivalent on January 23, 2017. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Ansell Healthcare Products, LLC has at least 10 other 510(k) clearances on record.