510(k) Report

Devices descending from K102652

8 later devices reach Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141467Surgical GownXuchang Zhengde Environstar Medical Products Co.,L20151—
+1K121152Surgical Gown, SMSJiangsu Guangda Medical Material, Co., Ltd.20127—
+2K212812Surgical GownXianning Marveldas Protective Articles Co., Ltd.20220—
+2K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd.20213—
+2K210215Surgical GownsJiangsu Province Jianerkang Medical Dressing Co., Ltd.20210—
+3K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…Hubei Xinxin Non-Woven Co., Ltd.20260—
+3K222456High Protection Surgical Gown3A Medical Products Co., Ltd.20230—
+3K221139Bodygard SFS Surgical Gown Level 4Feliks Plastik Laminasyon VE Ambalaj Malzemeleri20220—