510(k) Report

Devices descending from K201691

3 later devices reach Single-Use Surgical Mask With Ear Loop through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2206373 Ply Medical Grade Single Use Procedural Disposable Face MaskKdi Med Supply20220—
+1K210102Topwide Surgical Face MaskTopwide (Hubei) Medical Products Manufacturer20210—
+1K203455Disposable Medical MaskFujian Kang Chen Daily Necessities Co., Ltd.20210—