510(k) Report

Devices descending from K153409

7 later devices reach Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203388Disposable medical maskEverwin Toys (Dongguan)., Ltd.20210—
+1K201095Sovereign America Surgical Face MaskHomtex, Inc.20210—
+1K201974Single-use medical face maskGuangdong Horigen Mother & Baby Products Co., Ltd.20210—
+1K202316Medical mask (Model: KKF-1A)Han Zhaoqing Sporting Goods Company Limited20210—
+1K201622Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd.20202—
+2K231155Biodegradable Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd.20230—
+2K213450Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd.20220—