510(k) Report

Devices descending from K202211

3 later devices reach Disposable Medical Surgical Face Masks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203078CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AWHuizhou Tianchang Industrial Co., Ltd.20220—
+1K220487Disposable Medical Face MaskHubei Mediunion Medical Products Co., Ltd.20220—
+1K210815Disposable Face MaskBiobase Scientific (Shandong) Co., Ltd.20210—