510(k) Report

Devices descending from K911334

15 later devices reach Mask, Surgical Apparel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200847Surgical Face MaskMexpo International, Inc.202014—
+2K221682Ideal Med Pro 3-Ply Disposable Face MaskJsn Holdings, LLC20230—
+2K212203Dong Hai Xiang Surgical MaskTaizhou Donghaixiang Protective Equipment Co., Ltd.20220—
+2K213894DWFritz ASM2000Dwfritz Automation, Inc.20220—
+2K210679Medical Face MaskWuxi Yushou Medical Appliances Co., Ltd.20220—
+2K211260Sheng Jing Tang Surgical MaskLiaoning Shengjingtang Biotechnology Co., Ltd.20220—
+2K212460Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))Guangzhou Zhengkang Medical Equipment Co.,Ltd20210—
+2K210878Surgical Face Mask (Model: CM2006, CM2008, A88)Shenzhen Realtone Medical Appliance Co., Ltd.20210—
+2K203756Disposable Surgical MaskLucky Textile Industrial (Wuxi) Co., Ltd.20210—
+2K211105Ear-Friendly MaskRay Co., Ltd.20212—
+2K202615Nordiwell Medical Face MaskChangzhou Combat Protective Equipment Co., Ltd.20201—
+2K202069BASE4 Disposable Medical MaskBase4 Group, Inc.20200—
+3K212398Surgical Face Mask (Non-sterile)Hubei Kimsoul Industrial Co., Ltd.20211—
+3K210181Nordiwell Surgical Face MaskChangzhou Combat Protective Equipment Co., Ltd.20210—
+4K222335Surgical MaskLuoyang Sunmed Devices Co., Ltd.20220—