510(k) Report

Devices descending from K211105

2 later devices reach Ear-Friendly Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212398Surgical Face Mask (Non-sterile)Hubei Kimsoul Industrial Co., Ltd.20211—
+2K222335Surgical MaskLuoyang Sunmed Devices Co., Ltd.20220—