510(k) Report

Devices descending from K211454

2 later devices reach Surgical mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222545Disposable Medical MaskGuangzhou Fuzelong Hygiene Material Co., Ltd.20230—
+1K213724Medical Surgical MaskHunan Zhenheyikang Medical Instrument Co., Ltd.20220—