510(k) Report

Devices descending from K212869

3 later devices reach Disposable Surgical Gown, Disposable Reinforced Surgical Gown through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…Hubei Xinxin Non-Woven Co., Ltd.20260—
+1K222456High Protection Surgical Gown3A Medical Products Co., Ltd.20230—
+1K221139Bodygard SFS Surgical Gown Level 4Feliks Plastik Laminasyon VE Ambalaj Malzemeleri20220—