510(k) Report

Devices descending from K140155

4 later devices reach Secure-Gard Surgical and Procedure Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192374Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam StripCardinal Health200, LLC20193—
+2K211762Altor Safety 4-Ply Surgical Mask (Model:62232)Altor Safety, LLC20211—
+2K201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3…Dukal Corporation20210—
+3K221209PRECISION ECO Compostable / Plant Based Procedural Mask with EarloopsPadm Medical, Inc.20230—