510(k) K200672

Durex Penck Standard, Durex Penck XL by Rb Health (Us), LLC — Product Code HIS

K200672 is an FDA 510(k) premarket notification submitted by Rb Health (Us), LLC for the device "Durex Penck Standard, Durex Penck XL". The FDA issued a decision of Substantially Equivalent on November 6, 2020. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Rb Health (Us), LLC has at least 10 other 510(k) clearances on record.