510(k) Report

Devices descending from K143287

10 later devices reach Fluidshield* Surgical Mask with Expanded Chamber through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232894HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining…Owens & Minor (O&M) Halyard, Inc.20240—
+1K202358Protective Face Mask for Medical UseHunan Heng Chang Pharmaceutical Co., Ltd.20210—
+1K201537Protective Face Mask for Medical UseShandong Shengquan New Material Co., Ltd.20204—
+1K1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield3M Healthcare20182—
+2K212205Medical Protective MasksQinhuangdao Taizhi Medical Technology Co., Ltd.20211—
+2K210445Nordiwell Surprotect Face MaskChangzhou Combat Protective Equipment Co., Ltd.20211—
+2K202107Medical Protective MaskGuangdong Kingfa Sci. & Tech.Co., Ltd.20211—
+3K223686Medical Protective MasksQinhuangdao Taizhi Medical Technology Co., Ltd.20230—
+3K212740Puravita Medical Fold Flat Surgical MaskPuravita M, LLC20210—
+3K211497Surgical MaskHoneywell Safety Products20210—