510(k) Report

Devices descending from K061864

6 later devices reach Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111559Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd.20114—
+1K070407Dukal Surgical Face Mask Tie, Ear Loop, with Shield Yellow & White; Anti Fog Tie, Loop…Dukal Corp.20070—
+2K201137Asept Surgical Face MaskPfm Medical, Inc.20203—
+3K203174Disposable Medical MaskDong Guan Kinyet Metal Products Co., Ltd.20210—
+3K203200Disposable Medical Surgical Face MaskGuangdong Haiou Medical Apparatus Co., Ltd.20211—
+4K210643Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd.20210—