510(k) Report

Devices descending from K211631

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221273Medical Face Mask (M001)Xingyu Medical Tech Co., Ltd.20220—
+1K221272Medical Face MaskShandong Xingyu Gloves Co., Ltd.20222—
+2K230617Surgical Face Mask (L 175*95mm)Henan Chaoya Medical Equipment Co., Ltd.20230—
+2K230093Disposable 4 Layers Surgical Face MaskSocial Medical Supply, LLC20230—