510(k) Report

Devices descending from K111559

4 later devices reach Surgical Masks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201137Asept Surgical Face MaskPfm Medical, Inc.20203—
+2K203174Disposable Medical MaskDong Guan Kinyet Metal Products Co., Ltd.20210—
+2K203200Disposable Medical Surgical Face MaskGuangdong Haiou Medical Apparatus Co., Ltd.20211—
+3K210643Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd.20210—