510(k) Report

Devices descending from K191355

12 later devices reach 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251902Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield…Vitacore Industries, Inc.20250—
+1K222749High Fluid-Resistant Surgical and Procedure MaskAmerica’S Supply Chains20220—
+1K211771The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical…The Good Corporation20220—
+1K210147Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face…Unicoglobal, Inc.20211—
+1K202697United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid…United Sewing Automation, Inc.20210—
+1K202387Disposable Surgical Face MaskGuangdong Bida Medical Technology Co., Ltd.20210—
+1K202655Disposable Medical MaskDongguan Runlin Medical Supplies Technology Co., Ltd.20210—
+1K201924Single-Use Surgical MaskQiqihar Hengxin Medical Supplies, Ltd.20211—
+1K202205Surgical Face MaskJiangsu Micsafe Medical Technology Co., Ltd.20210—
+1K202214IFM Surgical Mask Model SM3Fssc, LLC20210—
+2K222266Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)Jingzhou Haixin Green Cross Medical Products Co., Ltd.20220—
+2K214094ROKI Surgical MaskRoki Co., Ltd.20220—