510(k) Report

Devices descending from K211462

3 later devices reach Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220194Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20222—
+2K250082Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20250—
+2K223232Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20231—