510(k) Report

Devices descending from K212368

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222483Surgical Face MaskHubei Woozon Healthcare Co., Ltd.20230—
+1K222529Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.20220—
+1K220670MagnumMagnum Health and Safety Pvt, Ltd.20221—
+2K251902Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield…Vitacore Industries, Inc.20250—