510(k) Report

Devices descending from K063043

5 later devices reach Surgical Face Mask, Type: Tie-on, Ear-Loop through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201549Motex Anti-Fog Surgical Face MaskModern Healthcare Corp.20201—
+1K123115Acme Surgical Face Mask with Ear-Loop Model YN-501 AB/W/G/PAcme Filter Mask, Inc.20132—
+2K203376ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400GMedtecs (Taiwan) Corp.20220—
+2K212863Surgical Face MaskTaiwan Comfort Champ Manufacturing Co., Ltd.20220—
+2K202126Disposable Surgical MaskShenzhen Peninsula Medical Co., Ltd.20210—