510(k) Report

Devices descending from K202096

2 later devices reach 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220378Sparta 3-Ply Surgical Disposable Face MaskSparta East, LLC20220—
+1K211097Banyan USA Surgical Mask Level 3Banyan USA, LLC20210—