510(k) Report

Devices descending from K160399

4 later devices reach Skyn Original Polyisoprene Lubricated Male Condom through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232470Polyisoprene Extra Large CondomSuretex Limited20240—
+1K23190845 Micron Polyisoprene CondomSuretex Limited20230—
+1K171172Skyn Original Polyisoprene Lubricated Male Condom - FlavoredAnsell Healthcare Products, LLC20171—
+2K182438Synthetic Polyisoprene Lubricated Male Condom - 5 sensesSxwell USA, LLC20180—