510(k) Report

Devices descending from K202511

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211536Welspun Health Surgical MaskWelspun India Limited20210—
+1K212097Disposable medical surgical maskHebei Titans Hongsen Medical Technology Co., Ltd.20212—
+2K221222Surgical Face Mask (HNFM0304)Shanghai Hua EN Industrial Co, Ltd.20221—
+3K222651Surgical Face MaskXiantao Sanda Industrial Co., Ltd.20220—