510(k) Report

Devices descending from K101000

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220520PM Excellence SEQUR 100 Surgical Face MaskPm Excellence, LLC20220—
+1K123787Greencross Surgical MaskJingzhou Haixin Green Cross Medical Products Co.,L20132—
+2K141085WestTec Procedure Facemask;WestTec Surgical FacemaskWesttec, LLC20151—
+3K210513UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2Universal Incorporation20210—