510(k) Report

Devices descending from K091097

10 later devices reach Promedical Surgical Gown, Models 18-301, 18-401 and 18-501 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093115Kimberly-Clark KC100 Surgical Gown, Model KC100Kimberly-Clark Corp.20109—
+2K102652Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced…Gri Medical & Electronic Technology Co., Ltd.20118—
+3K141467Surgical GownXuchang Zhengde Environstar Medical Products Co.,L20151—
+3K121152Surgical Gown, SMSJiangsu Guangda Medical Material, Co., Ltd.20127—
+4K212812Surgical GownXianning Marveldas Protective Articles Co., Ltd.20220—
+4K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd.20213—
+4K210215Surgical GownsJiangsu Province Jianerkang Medical Dressing Co., Ltd.20210—
+5K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…Hubei Xinxin Non-Woven Co., Ltd.20260—
+5K222456High Protection Surgical Gown3A Medical Products Co., Ltd.20230—
+5K221139Bodygard SFS Surgical Gown Level 4Feliks Plastik Laminasyon VE Ambalaj Malzemeleri20220—