510(k) Report

Devices descending from K163107

5 later devices reach Lifestyles Zero Lubricated Latex Male Condom through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex Limited20250—
+1K200672Durex Penck Standard, Durex Penck XLRb Health (Us), LLC20203—
+2K222068Durex Penck III RegularRb Health (Us), LLC20220—
+2K213647Durex Patronus WideRb Health (Us), LLC20221—
+3K220489Durex Patronus CloseFit, Durex Patronus RegularRb Health (Us), LLC20220—