510(k) Report

Devices descending from K202595

3 later devices reach Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2316183 Layer Surgical Mask (134252531)Original Mattress Factory, Inc.20230—
+1K212046Impertech Surgical Face MaskImpertech Industries, Ltd.20210—
+1K211861TAIJI Professional Series Level 3 Surgical Face MaskTaiji Medical Supplies, Inc.20210—