510(k) Report

Devices descending from K212097

2 later devices reach Disposable medical surgical mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221222Surgical Face Mask (HNFM0304)Shanghai Hua EN Industrial Co, Ltd.20221—
+2K222651Surgical Face MaskXiantao Sanda Industrial Co., Ltd.20220—