510(k) Report

Devices descending from K081633

3 later devices reach Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face Masks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240286PRIMED Surgical Masks and PRIMED Procedure MasksPrimed Medical Products, Inc.20241—
+1K092012Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium, Large) Model…Primed Medical Products, Inc.20090—
+2K252964PRIMED Surgical and Procedure MasksPrimed Medical Products, Inc.20250—