510(k) Report

Devices descending from K071313

13 later devices reach Trojan-Enz Brand through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161195Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)M3 Global Enterprises, LLC20160—
+1K103119Billy Boy Male Latex CondomSheila Pickering PHD20115—
+1K083817M. Dior BrandSuzhou Colour-Way Enterprise Development Co., Ltd.20095—
+2K162919Male Latex CondomsZhejiang Xiangban Latex Products Co., Ltd.20173—
+2K150828O-RING CondomO-Ring Products, LLC20150—
+2K120287Trojan Magnum Condom with Fire & Ice LubricantChurch & Dwight Co., Inc.20120—
+2K120394Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC201211
+2K111093Billy Boy Male Latex CondomMapa GmbH20111—
+3K220576FAMA Male Latex CondomsShanghai Personage Hygiene Products Co., Ltd.20222—
+3K153016aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products, Ltd.20160—
+3K141256Okamoto Studded CondomOkamoto USA, Inc.20140—
+4K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms –…Shanghai Personage Hygiene Products Co., Ltd.20260—
+4K232279LifeStyles NRL Textured CondomSuretex Limited20230—