510(k) Report

Devices descending from K201629

3 later devices reach Medical Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211552Surgical maskShandong Shengquan New Materials Co., Ltd.20212—
+2K221173Surgical Mask (Model: 0868F, 0866F)Jiangxi Sanhao Medical Instruments Co.,Ltd20220—
+2K220187Medical Surgical Mask (Model: JM92, JM92B)Guangdong Jia Mei Biological Technology Co.Ltd20220—