510(k) Report

Devices descending from K202463

4 later devices reach Disposable Surgical Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220378Sparta 3-Ply Surgical Disposable Face MaskSparta East, LLC20220—
+1K211165Medical Face Masks, Model Name:MY020003Huizhou Jie Bai Purification Co., Ltd.20210—
+1K210348Disposable Medical Surgical MaskWeihai Dishang Medical Technology Co., Ltd.20210—
+1K211249Altor Safety 3-Ply Surgical Mask (Model:62222)Altor Safety, LLC20210—