510(k) Report

Devices descending from K190950

5 later devices reach Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.20260—
+1K250564Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.20250—
+1K220435SEJONG Surgical Gown SoftSejong Healthcare Co., Ltd.20230—
+1K203548EndoArmor™ + Surgical GownBoston Scientific Corporation20220—
+1K203539Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical…Unicoglobal, Inc.20210—