510(k) Report

Devices descending from K182514

29 later devices reach Surgical Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212059Surgical Face MaskZhongshan Saifute Labor Protective Articles Co., Ltd.20210—
+1K212235Surgical Face MaskShanghai Yunqing Industrial Co., Ltd.20210—
+1K210042Disposable Surgical MaskSuzhou Letian Protective Products Co., Ltd.20210—
+1K210856Purism Disposable Surgical MaskChuzhou Daddy'S Choice Science and Technology Co., Ltd.20210—
+1K210007Face MaskJinhua Jingdi Medical Supplies Co., Ltd.20211—
+1K203426Surgical Face Mask (non-sterile)Nantong Taiweishi Medical Technology Co., Ltd.202113—
+1K210063Freudenberg Surgical MaskFreudenberg Performance Materials LP20212—
+1K202511Disposable Medical Surgical MaskImprove Medical (Hunan) Co., Ltd.20214—
+1K201893Disposable Surgical MaskXiamen Probtain Medical Techology Co., Ltd.20200—
+2K220749Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOPUnimax Medical Products Co., Ltd.20220—
+2K213617Surgical Face MaskMegasoft (China) Co., Ltd.20221—
+2K212111Myflon Surgical Mask Level 3Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi20220—
+2K212109Spin Care Disposable Protective Mask Level 3Spintech, LLC20210—
+2K212526Surgical Face MaskSuzhou Janee Medical Technology Co., Ltd.20210—
+2K211794Disposable surgical maskShanghai No.9 Knitting Mill Co., Ltd.20210—
+2K211536Welspun Health Surgical MaskWelspun India Limited20210—
+2K212097Disposable medical surgical maskHebei Titans Hongsen Medical Technology Co., Ltd.20212—
+2K211631Surgical Face MaskMacheng Thimble Technology Investment Co., Ltd.20214—
+2K211353Medical Face MaskShenzhen Lyttop Healthcare Limited20210—
+2K211363Medical Face MaskHubei Kangning Protective Products Co., Ltd.20210—
+2K210244Disposable Medical Face MaskSuzhou Bolisi Medical Technology Co., Ltd.20210—
+2K211062Medical Face MaskAmmex-Weida (Hubei) Health and Safety Products Co., Ltd.20210—
+3K222426Perfetta Moderate Medical Face MaskPhu Bao Group Company Limited20220—
+3K221273Medical Face Mask (M001)Xingyu Medical Tech Co., Ltd.20220—
+3K221272Medical Face MaskShandong Xingyu Gloves Co., Ltd.20222—
+3K221222Surgical Face Mask (HNFM0304)Shanghai Hua EN Industrial Co, Ltd.20221—
+4K230617Surgical Face Mask (L 175*95mm)Henan Chaoya Medical Equipment Co., Ltd.20230—
+4K230093Disposable 4 Layers Surgical Face MaskSocial Medical Supply, LLC20230—
+4K222651Surgical Face MaskXiantao Sanda Industrial Co., Ltd.20220—