510(k) Report

Devices descending from K212344

1 later device reach Surgical Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230395Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)Durio Ppe Sdn Bhd20230—