510(k) Report

Devices descending from K214087

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222809Medical Disposable Face MasksAnqing Mayfield Medical Limited20231—
+2K240258Disposable Medical Face Mask (M643BE)Makrite Industries, Inc.20240—