510(k) Report

Devices descending from K983380

8 later devices reach Durex Lubragel Latex Condom through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032227Durex Flavored Latex CondomSsl Americas, Inc.20047—
+2K081413Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd.20086—
+3K103119Billy Boy Male Latex CondomSheila Pickering PHD20115—
+4K120287Trojan Magnum Condom with Fire & Ice LubricantChurch & Dwight Co., Inc.20120—
+4K120394Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC201211
+4K111093Billy Boy Male Latex CondomMapa GmbH20111—
+5K153016aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products, Ltd.20160—
+5K141256Okamoto Studded CondomOkamoto USA, Inc.20140—