510(k) Report

Devices descending from K897129

17 later devices reach Condoms (Multiple Brands) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071313Trojan-Enz BrandChurch & Dwight Co., Inc.200713—
+1K071272Trojan Thintensity Brand Male Latex CondomChurch & Dwight Co., Inc.20078—
+2K161195Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)M3 Global Enterprises, LLC20160—
+2K103119Billy Boy Male Latex CondomSheila Pickering PHD20115—
+2K083817M. Dior BrandSuzhou Colour-Way Enterprise Development Co., Ltd.20095—
+2K073016Trojan Thintensity Brand Male Latex Condom Lubricated with Ultrasmooth and Warm…Church & Dwight Co., Inc.20077—
+3K162919Male Latex CondomsZhejiang Xiangban Latex Products Co., Ltd.20173—
+3K150828O-RING CondomO-Ring Products, LLC20150—
+3K120287Trojan Magnum Condom with Fire & Ice LubricantChurch & Dwight Co., Inc.20120—
+3K120249Trojan Magnum Condom with Warming LubricantChurch & Dwight Virginia Co., Inc.20120—
+3K120394Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC201211
+3K111093Billy Boy Male Latex CondomMapa GmbH20111—
+4K220576FAMA Male Latex CondomsShanghai Personage Hygiene Products Co., Ltd.20222—
+4K153016aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products, Ltd.20160—
+4K141256Okamoto Studded CondomOkamoto USA, Inc.20140—
+5K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms –…Shanghai Personage Hygiene Products Co., Ltd.20260—
+5K232279LifeStyles NRL Textured CondomSuretex Limited20230—