510(k) Report

Devices descending from K200847

14 later devices reach Surgical Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221682Ideal Med Pro 3-Ply Disposable Face MaskJsn Holdings, LLC20230—
+1K212203Dong Hai Xiang Surgical MaskTaizhou Donghaixiang Protective Equipment Co., Ltd.20220—
+1K213894DWFritz ASM2000Dwfritz Automation, Inc.20220—
+1K210679Medical Face MaskWuxi Yushou Medical Appliances Co., Ltd.20220—
+1K211260Sheng Jing Tang Surgical MaskLiaoning Shengjingtang Biotechnology Co., Ltd.20220—
+1K212460Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))Guangzhou Zhengkang Medical Equipment Co.,Ltd20210—
+1K210878Surgical Face Mask (Model: CM2006, CM2008, A88)Shenzhen Realtone Medical Appliance Co., Ltd.20210—
+1K203756Disposable Surgical MaskLucky Textile Industrial (Wuxi) Co., Ltd.20210—
+1K211105Ear-Friendly MaskRay Co., Ltd.20212—
+1K202615Nordiwell Medical Face MaskChangzhou Combat Protective Equipment Co., Ltd.20201—
+1K202069BASE4 Disposable Medical MaskBase4 Group, Inc.20200—
+2K212398Surgical Face Mask (Non-sterile)Hubei Kimsoul Industrial Co., Ltd.20211—
+2K210181Nordiwell Surgical Face MaskChangzhou Combat Protective Equipment Co., Ltd.20210—
+3K222335Surgical MaskLuoyang Sunmed Devices Co., Ltd.20220—