510(k) Report

Devices descending from K983320

3 later devices reach Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030176Lifestyles, Contempo or Private Label-Male Latex Condom with Desensitizing LubricantSuretex, Ltd.20031—
+1K992081Various Ansell Tradenames or Private LabelSuretex Prophylactics (India), Ltd.19990—
+2K033541Long Love CondomUnidus Corp.20030—