510(k) Report

Devices descending from K822088

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020659Durex Latex Condom with Male Genital Desensitizer LubricantSsl Americas, Inc.20022—
+2K211152Durex Condom with BenzocaineRb Health (Us), LLC20221—
+3K230049SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots…Ttk Healthcare Limited20230—