510(k) K160399

Skyn Original Polyisoprene Lubricated Male Condom by Ansell Healthcare Products, LLC — Product Code MOL

K160399 is an FDA 510(k) premarket notification submitted by Ansell Healthcare Products, LLC for the device "Skyn Original Polyisoprene Lubricated Male Condom". The FDA issued a decision of Substantially Equivalent on July 25, 2016. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Ansell Healthcare Products, LLC has at least 10 other 510(k) clearances on record.