510(k) Report

Devices descending from K201137

3 later devices reach Asept Surgical Face Mask through their predicates, nearest generation first.

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