510(k) Report

Devices descending from K220194

2 later devices reach Procedure mask/Surgical mask/Face mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250082Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20250—
+1K223232Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20231—