510(k) Report

Devices descending from K153496

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K203426Surgical Face Mask (non-sterile)Nantong Taiweishi Medical Technology Co., Ltd.202113—
+2K201545Surgical Face MaskAmphastar Nanjing Pharmaceuticals, Inc.20210—
+2K210063Freudenberg Surgical MaskFreudenberg Performance Materials LP20212—
+2K202511Disposable Medical Surgical MaskImprove Medical (Hunan) Co., Ltd.20214—
+2K202595Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face MaskPremier Guard USA, LLC20213—
+2K202314Procedure face mask (Model: KKF-2A)Han Zhaoqing Sporting Goods Company Limited20210—
+2K201625Disposable Medical Surgical MaskTianjin Saiyuan Technology Co., Ltd.20210—
+2K201893Disposable Surgical MaskXiamen Probtain Medical Techology Co., Ltd.20200—
+2K201380Livocare Surgical MaskAndon Health Co, Ltd.20200—
+2K202463Disposable Surgical MaskUnisources Group, LLC20204—
+2K201517Plain Surgical MaskAok Tooling Limited20200—
+3K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.20260—
+3K232112R&G Surgical MaskR&G Seguridad E Higiene Industrial S.A.C.20240—
+3K232359Surgical face maskKingstar Medical (Xianning) Co., Ltd.20230—
+3K2316183 Layer Surgical Mask (134252531)Original Mattress Factory, Inc.20230—
+3K230395Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)Durio Ppe Sdn Bhd20230—
+3K213601Surgical MaskWuhan Zonsen Medical Products Co., Ltd.20220—
+3K221976Surgical Face Mask (Non-sterile)Xiantao Junhui Plastic Products Co., Ltd.20220—
+3K221038Disposable Medical MasksHantech Medical Device Co., Ltd.20220—
+3K220876AOK 95A Medical Mask (20200049)Aok Tooling Limited20220—
+3K221196Disposable Medical Face Mask (ear loop)Xiantao Topmed Nonwoven Protective Products Co., Ltd.20221—
+3K221173Surgical Mask (Model: 0868F, 0866F)Jiangxi Sanhao Medical Instruments Co.,Ltd20220—
+3K220550Disposable Surgical Face Mask (M663BE, M663BT)Makrite Industries, Inc.20220—
+3K220824Medical Surgical Mask (Planar type)Hunan Chopard Medical Devices Co., Ltd.20220—
+3K220749Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOPUnimax Medical Products Co., Ltd.20220—
+3K220512Disposable Surgical Face Mask (M01, M02)Fomed Industries, Inc.20220—
+3K210422INTAI Surgical Mask (non-sterile)Intai Technology Corp.20220—
+3K220187Medical Surgical Mask (Model: JM92, JM92B)Guangdong Jia Mei Biological Technology Co.Ltd20220—
+3K213806Disposable Medical Face MaskXiantao Zhibo Nonwoven Products Co., Ltd.20222—
+3K213617Surgical Face MaskMegasoft (China) Co., Ltd.20221—
+3K212111Myflon Surgical Mask Level 3Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi20220—
+3K213970D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 PlyDanameco Medical Joint Stock Corporation20220—
+3K212046Impertech Surgical Face MaskImpertech Industries, Ltd.20210—
+3K212109Spin Care Disposable Protective Mask Level 3Spintech, LLC20210—
+3K211165Medical Face Masks, Model Name:MY020003Huizhou Jie Bai Purification Co., Ltd.20210—
+3K212526Surgical Face MaskSuzhou Janee Medical Technology Co., Ltd.20210—
+3K210348Disposable Medical Surgical MaskWeihai Dishang Medical Technology Co., Ltd.20210—
+3K211794Disposable surgical maskShanghai No.9 Knitting Mill Co., Ltd.20210—
+3K203112Disposable Medical MaskYangzhou Runyi Arts & Crafts Co., Ltd.20210—
+3K211536Welspun Health Surgical MaskWelspun India Limited20210—
+3K212097Disposable medical surgical maskHebei Titans Hongsen Medical Technology Co., Ltd.20212—
+3K211631Surgical Face MaskMacheng Thimble Technology Investment Co., Ltd.20214—
+3K211353Medical Face MaskShenzhen Lyttop Healthcare Limited20210—
+3K211861TAIJI Professional Series Level 3 Surgical Face MaskTaiji Medical Supplies, Inc.20210—
+3K211363Medical Face MaskHubei Kangning Protective Products Co., Ltd.20210—
+3K211249Altor Safety 3-Ply Surgical Mask (Model:62222)Altor Safety, LLC20210—
+3K210244Disposable Medical Face MaskSuzhou Bolisi Medical Technology Co., Ltd.20210—
+3K211062Medical Face MaskAmmex-Weida (Hubei) Health and Safety Products Co., Ltd.20210—
+4K232797HygenixShenzhen Hygenix Industrial Co., Ltd.20230—
+4K223055Disposable Medical Face MaskXiantao Zhuobo Industrial Co., Ltd.20220—
+4K222697Disposable Medical Face Mask (DF3-001)Wellmed Dental Medical Supply Co., Ltd.20220—
+4K222426Perfetta Moderate Medical Face MaskPhu Bao Group Company Limited20220—
+4K221273Medical Face Mask (M001)Xingyu Medical Tech Co., Ltd.20220—
+4K221272Medical Face MaskShandong Xingyu Gloves Co., Ltd.20222—
+4K221222Surgical Face Mask (HNFM0304)Shanghai Hua EN Industrial Co, Ltd.20221—
+5K230617Surgical Face Mask (L 175*95mm)Henan Chaoya Medical Equipment Co., Ltd.20230—
+5K230093Disposable 4 Layers Surgical Face MaskSocial Medical Supply, LLC20230—
+5K222651Surgical Face MaskXiantao Sanda Industrial Co., Ltd.20220—