510(k) Report

Devices descending from K201729

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K214087Medical Face MaskHubei Medlink Healthcare Co., Ltd.20222—
+1K203012Surgical MaskCustomfab, Inc.20210—
+1K202708Surgical Face MasksIntco Medical (Hk) Co., Ltd.20210—
+2K222809Medical Disposable Face MasksAnqing Mayfield Medical Limited20231—
+3K240258Disposable Medical Face Mask (M643BE)Makrite Industries, Inc.20240—