510(k) Report

Devices descending from K201622

2 later devices reach Medical surgical mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231155Biodegradable Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd.20230—
+1K213450Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd.20220—