510(k) Report

Devices descending from K070800

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160399Skyn Original Polyisoprene Lubricated Male CondomAnsell Healthcare Products, LLC201641
+2K232470Polyisoprene Extra Large CondomSuretex Limited20240—
+2K23190845 Micron Polyisoprene CondomSuretex Limited20230—
+2K171172Skyn Original Polyisoprene Lubricated Male Condom - FlavoredAnsell Healthcare Products, LLC20171—
+3K182438Synthetic Polyisoprene Lubricated Male Condom - 5 sensesSxwell USA, LLC20180—