510(k) Report

Devices descending from K192290

13 later devices reach 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213893Comfort Gown, Safewear GownXuchang Zhengde Environstar Medical Products Co., Ltd.20220—
+1K22181935g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS…Winner Medical Co., Ltd.20220—
+1K203237Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown…Dukal Corporation20220—
+1K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd.20213—
+1K202706Surgical Gown (Sterile), Surgical Gown (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.20205—
+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—
+2K221559Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3Stringking20230—
+2K213844Surgical GownBayteks Teknik Tekstil San. VE Tic. A.S.20230—
+2K221139Bodygard SFS Surgical Gown Level 4Feliks Plastik Laminasyon VE Ambalaj Malzemeleri20220—
+2K221637Surgical Gown (Sterile); Surgical Gown (Non-sterile)Allmed Medical (Hubei) Protective Products Co., Ltd.20220—
+2K211399Sterile Level 3 Surgical GownBarco Tekstil Sanayi VE Ticaret A.S.20220—
+2K210355Surgical Gown, Model: surgical gown-hp-3Weihai Dishang Medical Technology Co., Ltd.20210—