510(k) Report

Devices descending from K210433

5 later devices reach Surgical Face Mask (Ear loops and Tie-on) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232359Surgical face maskKingstar Medical (Xianning) Co., Ltd.20230—
+1K221196Disposable Medical Face Mask (ear loop)Xiantao Topmed Nonwoven Protective Products Co., Ltd.20221—
+1K220550Disposable Surgical Face Mask (M663BE, M663BT)Makrite Industries, Inc.20220—
+1K220512Disposable Surgical Face Mask (M01, M02)Fomed Industries, Inc.20220—
+2K232797HygenixShenzhen Hygenix Industrial Co., Ltd.20230—