510(k) Report

Devices descending from K023117

2 later devices reach Primagard Surgical Gowns through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101593Emm Surgical Gown-SMS with PE Layer, Model 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXLExact Medical Manufacturing, Inc.20100—
+1K033057Deroyal Surgical Gowns, Sterile, Non-SterileDeroyal20030—