510(k) Report

Devices descending from K941258

14 later devices reach Latex Condom through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163107Lifestyles Zero Lubricated Latex Male CondomAnsell Healthcare Products, LLC20175—
+1K070800Lifestyles Lubricated Polyisoprene Latex Male CondomAnsell Healthcare Products, LLC20085—
+1K994095Latex CondomThai Nippon Rubber Industry Co., Ltd.20001—
+2K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex Limited20250—
+2K200672Durex Penck Standard, Durex Penck XLRb Health (Us), LLC20203—
+2K160399Skyn Original Polyisoprene Lubricated Male CondomAnsell Healthcare Products, LLC201641
+2K012653Male Latex CondomQingdao Shuang Die Latex Production Co.,Ltd20010—
+3K232470Polyisoprene Extra Large CondomSuretex Limited20240—
+3K23190845 Micron Polyisoprene CondomSuretex Limited20230—
+3K222068Durex Penck III RegularRb Health (Us), LLC20220—
+3K213647Durex Patronus WideRb Health (Us), LLC20221—
+3K171172Skyn Original Polyisoprene Lubricated Male Condom - FlavoredAnsell Healthcare Products, LLC20171—
+4K220489Durex Patronus CloseFit, Durex Patronus RegularRb Health (Us), LLC20220—
+4K182438Synthetic Polyisoprene Lubricated Male Condom - 5 sensesSxwell USA, LLC20180—