510(k) Report

Devices descending from K162919

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220576FAMA Male Latex CondomsShanghai Personage Hygiene Products Co., Ltd.20222—
+2K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms –…Shanghai Personage Hygiene Products Co., Ltd.20260—
+2K232279LifeStyles NRL Textured CondomSuretex Limited20230—