510(k) Report

Devices descending from K220576

2 later devices reach FAMA Male Latex Condoms through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms –…Shanghai Personage Hygiene Products Co., Ltd.20260—
+1K232279LifeStyles NRL Textured CondomSuretex Limited20230—