510(k) Report

Devices descending from K210622

1 later device reach Single-Use Medical Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223068Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)Guangdong Golden Leaves Technology Development Co., Ltd.20220—