510(k) Report

Devices descending from K801036

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K133070SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd.2015170—
+4K143287Fluidshield* Surgical Mask with Expanded ChamberHalyard Health, Inc.201510—
+4K140155Secure-Gard Surgical and Procedure Face MaskCardinal Health200, LLC20144—
+4K111559Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd.20114—
+4K110027Surgical Face Mask; Surgical Face MaskAngeline Group, Ltd.20110—
+4K070407Dukal Surgical Face Mask Tie, Ear Loop, with Shield Yellow & White; Anti Fog Tie, Loop…Dukal Corp.20070—
+5K252650Disposable Medical Face MaskMakrite Industries, Inc.20260—
+5K251902Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield…Vitacore Industries, Inc.20250—
+5K232894HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining…Owens & Minor (O&M) Halyard, Inc.20240—
+5K221753Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd.20230—
+5K222545Disposable Medical MaskGuangzhou Fuzelong Hygiene Material Co., Ltd.20230—
+5K223236Medline Surgical Face Mask and Medline Procedural Face MaskMedline Industries, LP20230—
+5K221352Surgical Face MaskWuhan Huashida Protective Products Co., Ltd.20230—
+5K222809Medical Disposable Face MasksAnqing Mayfield Medical Limited20231—
+5K223068Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)Guangdong Golden Leaves Technology Development Co., Ltd.20220—
+5K222749High Fluid-Resistant Surgical and Procedure MaskAmerica’S Supply Chains20220—
+5K212926AllureTM Surgical MaskAllure Gift Wraps Private Limited20220—
+5K220067Medical Surgery Mask, Model:2626-7Dongguan Missadola Technology Co., Ltd.20220—
+5K211771The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical…The Good Corporation20220—
+5K221838Surgical Face Mask (HNFM0103)Shanghai Hua EN Industrial Co, Ltd.20220—
+5K220191Disposable Face MaskJiujiang Taixin Technology Co., Ltd.20220—
+5K220194Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20222—
+5K213450Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd.20220—
+5K210321Dukal Corporation Level 1 Pediatric Face MaskDukal Corporation20221—
+5K212330Yadu Medical Face Mask (Level 1)Henan Yadu Industrial Co., Ltd.20220—
+5K213724Medical Surgical MaskHunan Zhenheyikang Medical Instrument Co., Ltd.20220—
+5K203161Surgical Face MaskWuhan Raytex Protection Co., Ltd.20220—
+5K211833Disposable Medical Face MaskZhejiang the Purples Protective Products Co.,Ltd20220—
+5K212997Surgical MaskGuangdong Zhizhen Biological Medical Co., Ltd.20220—
+5K202255Skypro, SP02 Mask (3)Skypro Medical Supplies Company20210—
+5K210147Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face…Unicoglobal, Inc.20211—
+5K211696Disposable Surgical Face MaskAnhui Cleanpro Pharmpack Co., Ltd.20210—
+5K212293Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)Jiangmen Ningrui Medical Supplies Co., Ltd.20213—
+5K210845Disposable Surgical Mask (Model: YYKZ-01)Jiaxing Amazing Travel-Ware Co., Ltd.20210—
+5K210698ECOMA Level 2 Disposable Surgical Mask with Ear LoopsXianning Eco Medical Articles Co., Ltd.20210—
+5K202899Procedure Mask, Surgical MaskKenpax International Limited20211—
+5K203646Disposable Medical Face MaskGuangzhou Mei YI Kang Medical Technology Co., Ltd.20210—
+5K202761Medical Surgical Mask (Non-sterile)Guangdong Goodfeeling Hygiene Material Tec Co., Ltd.20212—
+5K202655Disposable Medical MaskDongguan Runlin Medical Supplies Technology Co., Ltd.20210—
+5K210023Surgical Face MaskGuangdong Winsun Personal Care Products Co.,Ltd20210—
+5K201924Single-Use Surgical MaskQiqihar Hengxin Medical Supplies, Ltd.20211—
+5K202548Surgical Face MaskWanxinda (Guangzhou) Technology Product Co., Ltd.20210—
+5K202710Disposable Medical Face MaskWanxinda (Guangzhou) Technology Product Co., Ltd.20210—
+5K202205Surgical Face MaskJiangsu Micsafe Medical Technology Co., Ltd.20210—
+5K202214IFM Surgical Mask Model SM3Fssc, LLC20210—
+5K202358Protective Face Mask for Medical UseHunan Heng Chang Pharmaceutical Co., Ltd.20210—
+5K201537Protective Face Mask for Medical UseShandong Shengquan New Material Co., Ltd.20204—
+5K201137Asept Surgical Face MaskPfm Medical, Inc.20203—
+5K192374Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam StripCardinal Health200, LLC20193—
+5K190308Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom…Amd Medicom, Inc.20190—
+5K1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield3M Healthcare20182—
+5K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.2016158—
+6K250082Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20250—
+6K240258Disposable Medical Face Mask (M643BE)Makrite Industries, Inc.20240—
+6K223823Disposable Surgical Face MaskEfofex, Inc.20231—
+6K223232Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20231—
+6K220302Disposable surgical face maskShandong Aida Medical Products Co., Ltd.20220—
+6K222266Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)Jingzhou Haixin Green Cross Medical Products Co., Ltd.20220—
+6K222204Medical Surgical MaskGuangzhou Zhengkang Medical Equipment Co.,Ltd20220—
+6K220777Surgical face maskHubei Qianjiang Kingphar Medical Material Co., Ltd.20221—
+6K221173Surgical Mask (Model: 0868F, 0866F)Jiangxi Sanhao Medical Instruments Co.,Ltd20220—
+6K221134Procedure Mask with Ear Loops and Surgical Mask with TiesSafesource Direct, LLC20220—
+6K220187Medical Surgical Mask (Model: JM92, JM92B)Guangdong Jia Mei Biological Technology Co.Ltd20220—
+6K214094ROKI Surgical MaskRoki Co., Ltd.20220—
+6K212826Disposable Medical MaskJiangsu Nanfang Medical Co., Ltd.20220—
+6K211378LM Surgical Mask Level 3, LM Surgical Mask Level 2,Liberty Mask, LLC20210—
+6K210744Surgical MaskChongqing PA Xijia Biotechnology Co., Ltd.20210—
+6K212867Medical Surgical MaskNanchang Kanghua Health Materials Co., Ltd.20210—
+6K212205Medical Protective MasksQinhuangdao Taizhi Medical Technology Co., Ltd.20211—
+6K211832Fluid Resistant Procedure Mask, Fluid Resistant Surgical MaskZhejiang Lanhine Medical Products, Ltd.20210—
+6K211762Altor Safety 4-Ply Surgical Mask (Model:62232)Altor Safety, LLC20211—
+6K211576WYZ Surgical MaskWyz Medical Supplies, LLC20210—
+6K203174Disposable Medical MaskDong Guan Kinyet Metal Products Co., Ltd.20210—
+6K210409Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd.20210—
+6K210267Disposable Surgical MaskXiamen Eagledon Pharmaceutical Co., Ltd.20210—
+6K210445Nordiwell Surprotect Face MaskChangzhou Combat Protective Equipment Co., Ltd.20211—
+6K210840Disposable Surgical MaskSafeway Industry Healthcare.20210—
+6K203200Disposable Medical Surgical Face MaskGuangdong Haiou Medical Apparatus Co., Ltd.20211—
+6K203732Surgical Face MaskZhuhai Gaoge Medical Technology Co., Ltd.20210—
+6K210641Disposable Medical MaskTuosheng Protective Products (Ningbo) Co., Ltd.20210—
+6K210030Medical Surgical MaskTianjin Aoshang Outdoor Equipment Co., Ltd.20214—
+6K202513Disposable Medical Face Mask-Model FM-04Shenzhen Jinko Industrial Co., Ltd.20211—
+6K203801Disposable Surgical Face MaskAnhui Jiabao Protective Equipments Co., Ltd.20211—
+6K202191Surgical MaskWuhan Zonsen Medical Products Co., Ltd.20210—
+6K210487MIPLNI YK-244 Disposable Surgical MaskHunan Yuankang Biological Technology Co., Ltd.20210—
+6K203775AIC disposable medical maskThe Aleen International Corporation20210—
+6K202161Surgical Face MaskHunan Eexi Technology & Service Co., Ltd.20211—
+6K202409Surgical MaskAllmed Medical Products Co., Ltd.20210—
+6K202439Disposable Medical Face MaskHunan Eexi Technology & Service Co., Ltd.20210—
+6K203524Surgical MasksBain Medical Equipment (Guangzhou) Co., Ltd.20210—
+6K201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3…Dukal Corporation20210—
+6K202605Standard Procedure Mask, Standard Surgical MaskJiangsu Medplus Non-Woven Manufacturer Co., Ltd.20212—
+6K202627Medical Face MasksGuilin Hbm Sanitary Protections, Inc.20210—
+6K202331Medical Face MaskGemtier Medical (Shanghai), Inc.20210—
+6K202323Disposable Medical Surgical MasksTianjin Teda Jinshan Easy Packing Manufacture Co., Ltd.20210—
+6K2020963-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-OnEcoguard, Inc.20212—
+6K202640Surgical MaskJiangsu Medpure Biological Technology Co., Ltd.20210—
+6K202107Medical Protective MaskGuangdong Kingfa Sci. & Tech.Co., Ltd.20211—
+6K202594Medical Surgical Masks-Non SterileShandong T&F Nonwoven Co., Ltd.20212—
+6K202719Disposable Medical Face MasksJiangxi Sanxin Medtec Co., Ltd.20212—