510(k) Report

Devices descending from K082554

10 later devices reach Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500 and KC600 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233262Dukal SMS Sterilization WrapDukal, LLC20240—
+1K213907CareGUARD Sterilization WrapCare Essentials Pty, Ltd.20220—
+1K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC20166—
+1K143053KIMGUARD ONE-STEP Sterilization WrapKimberly-Clark Health Care20151—
+2K223600Sterilization WrapWuhan Zonsen Medical Products Co., Ltd.20230—
+2K182656JAMBRO Single Core A Sterilization wrapJiangsu Zhande Medical Supplies Co., Ltd.20191—
+2K171533Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC20172—
+3K240438CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)Comercializadora Brever20240—
+3K230137Reliance® Fusion Sterilization WrapsAhlstrom-Munksjo Nonwovens, LLC20230—
+3K220133Sterilization WrapsWeihai Hongyu Nonwoven Fabric Products Co., Ltd.20220—