510(k) Report

Devices descending from K121152

7 later devices reach Surgical Gown, SMS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212812Surgical GownXianning Marveldas Protective Articles Co., Ltd.20220—
+1K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd.20213—
+1K141467Surgical GownXuchang Zhengde Environstar Medical Products Co.,L20151—
+2K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…Hubei Xinxin Non-Woven Co., Ltd.20260—
+2K222456High Protection Surgical Gown3A Medical Products Co., Ltd.20230—
+2K221139Bodygard SFS Surgical Gown Level 4Feliks Plastik Laminasyon VE Ambalaj Malzemeleri20220—
+2K210215Surgical GownsJiangsu Province Jianerkang Medical Dressing Co., Ltd.20210—