510(k) Report

Devices descending from K111402

262 later devices reach KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*…O&M Halyard, Inc.20260—
+1K243010Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)…Owens & Minor (O&M) Halyard, Inc.20250—
+1K232812Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask…Owens & Minor (O&M) Halyard, Inc.20240—
+1K220377Procedure MaskLittle Rapids Corporation20220—
+1K210101American-Made Surgical MaskArmbrust, Inc.20220—
+1K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd.201660—
+1K143287Fluidshield* Surgical Mask with Expanded ChamberHalyard Health, Inc.201510—
+1K140155Secure-Gard Surgical and Procedure Face MaskCardinal Health200, LLC20144—
+1K131879KC 300 Surgical MaskKimberly-Clark Corp.20131851
+2K232968Grande Medical Masks, Model SF-600Golden Grande Corp.20240—
+2K232894HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining…Owens & Minor (O&M) Halyard, Inc.20240—
+2K203528KNH Surgical Face MaskKnh Surgical Face Mask20220—
+2K221534Surgical Face Masks (Ear Loops And Tie-On)San-M Package Co., Ltd.20220—
+2K220944PointCore Surgical MaskPointcore, Inc.20220—
+2K221409Paneffort 3-ply Surgical and Procedural MasksPaneffort, LLC20220—
+2K202903Surgical Face MaskRizhao Sanqi Medical & Health Articles Co., Ltd.20222—
+2K212366Heartland Health Surgical MaskHeartland Health Products20220—
+2K212120Surgical MasksHubei Xinxin Non-Woven Co., Ltd.20221—
+2K212610Surgical Face MaskFoshan Nanhai Plus Medical Co, Ltd.20220—
+2K212994Medical Face MaskGuangzhou Quantum Laser Intelligent Equipment Co., Ltd.20220—
+2K212471Medical Face MaskHaian Medigauze Co., Ltd.20211—
+2K210222Disposable Medical MaskGuangdong Lide Medical Technology Co., Ltd.20210—
+2K210622Single-Use Medical Face MaskJiangxi Hongda Medical Equipment Group Co., Ltd.20211—
+2K211066Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask…Homtex, Inc.20210—
+2K211462Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face MaskXiantao S&J Protective Products Co., Ltd.20213—
+2K211454Surgical maskJiangsu Xingtong Biotechnology Group Co., Ltd.20212—
+2K210380Medical surgical maskShantou T&K Medical Equipment Factory Co.,Ltd20210—
+2K210524Surgical MaskChangzhou Holymed Products Co., Ltd.20210—
+2K210767Surgical Masks, Model:FE-1Hunan Triplex Precision Medical Devices Co., Ltd.20210—
+2K202128Allmed Surgical Face Masks (Ear loops)Allmed Medical Products Co., Ltd.20210—
+2K202697United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid…United Sewing Automation, Inc.20210—
+2K2025983 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3…3A Medical Products Co., Ltd.20211—
+2K202387Disposable Surgical Face MaskGuangdong Bida Medical Technology Co., Ltd.20210—
+2K202759Disposable medical surgical maskChongqing Coe Display Technology Co., Ltd.20210—
+2K201718GD Disposable Medical Face MaskJiangsu Guangda Medical Material Group Co., Ltd.20210—
+2K201127DEFEND Ear-loop Face MasksYoung Dental Manufacturing Co. 1, LLC20210—
+2K202424Surgical Mask-Models CR02-2, CR02Foshan Xinbao Technology Co., Ltd.20213—
+2K202905Disposable Face MaskJiangsu Excellence Medical Supplies Co., Ltd.20211—
+2K203776Surgical Masks, Model SNN200640 & MN112Sq Medical Supplies, Inc.20210—
+2K203064ICU Health Surgical MaskPlastikon Industries20210—
+2K201624Spin Care Disposable Protective MaskSpintech, LLC20210—
+2K210225Surgical Face MaskFeng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd.20210—
+2K202240Disposable Surgical Mask/Fluid Resistant Procedure MaskLhm Medical Technology (Hong Kong) Limited20210—
+2K201868Phyziofit Medical Surgical MaskWellpower Sporting Goods Co., Ltd.20210—
+2K202341Disposable Surgical MaskShanghai Jianzhong Medical Packaging Co., Ltd.20210—
+2K201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2…Dukal Corporation20210—
+2K202358Protective Face Mask for Medical UseHunan Heng Chang Pharmaceutical Co., Ltd.20210—
+2K202491Disposable Surgical Face MaskJiangsu Newvalue Medical Products Co., Ltd.20214—
+2K201754JianYu Surgical MaskJiangsu Jianyu Health Medical Co., Ltd.20200—
+2K202061Medical Face maskJiangsu Province Jianerkang Medical Dressing Co., Ltd.20202—
+2K201991Medical surgical maskShenzhen Everwin Precision Technology Co., Ltd.20200—
+2K201537Protective Face Mask for Medical UseShandong Shengquan New Material Co., Ltd.20204—
+2K192374Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam StripCardinal Health200, LLC20193—
+2K1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask3M Healthcare201912—
+2K1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield3M Healthcare20182—
+2K133070SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd.2015170—
+3K252650Disposable Medical Face MaskMakrite Industries, Inc.20260—
+3K251902Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield…Vitacore Industries, Inc.20250—
+3K222545Disposable Medical MaskGuangzhou Fuzelong Hygiene Material Co., Ltd.20230—
+3K223236Medline Surgical Face Mask and Medline Procedural Face MaskMedline Industries, LP20230—
+3K221352Surgical Face MaskWuhan Huashida Protective Products Co., Ltd.20230—
+3K223068Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)Guangdong Golden Leaves Technology Development Co., Ltd.20220—
+3K222749High Fluid-Resistant Surgical and Procedure MaskAmerica’S Supply Chains20220—
+3K212926AllureTM Surgical MaskAllure Gift Wraps Private Limited20220—
+3K220067Medical Surgery Mask, Model:2626-7Dongguan Missadola Technology Co., Ltd.20220—
+3K211771The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical…The Good Corporation20220—
+3K221838Surgical Face Mask (HNFM0103)Shanghai Hua EN Industrial Co, Ltd.20220—
+3K220191Disposable Face MaskJiujiang Taixin Technology Co., Ltd.20220—
+3K220194Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20222—
+3K212330Yadu Medical Face Mask (Level 1)Henan Yadu Industrial Co., Ltd.20220—
+3K213724Medical Surgical MaskHunan Zhenheyikang Medical Instrument Co., Ltd.20220—
+3K203161Surgical Face MaskWuhan Raytex Protection Co., Ltd.20220—
+3K211833Disposable Medical Face MaskZhejiang the Purples Protective Products Co.,Ltd20220—
+3K212997Surgical MaskGuangdong Zhizhen Biological Medical Co., Ltd.20220—
+3K210147Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face…Unicoglobal, Inc.20211—
+3K211696Disposable Surgical Face MaskAnhui Cleanpro Pharmpack Co., Ltd.20210—
+3K212293Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)Jiangmen Ningrui Medical Supplies Co., Ltd.20213—
+3K212205Medical Protective MasksQinhuangdao Taizhi Medical Technology Co., Ltd.20211—
+3K210845Disposable Surgical Mask (Model: YYKZ-01)Jiaxing Amazing Travel-Ware Co., Ltd.20210—
+3K211762Altor Safety 4-Ply Surgical Mask (Model:62232)Altor Safety, LLC20211—
+3K210698ECOMA Level 2 Disposable Surgical Mask with Ear LoopsXianning Eco Medical Articles Co., Ltd.20210—
+3K210445Nordiwell Surprotect Face MaskChangzhou Combat Protective Equipment Co., Ltd.20211—
+3K202899Procedure Mask, Surgical MaskKenpax International Limited20211—
+3K202761Medical Surgical Mask (Non-sterile)Guangdong Goodfeeling Hygiene Material Tec Co., Ltd.20212—
+3K202655Disposable Medical MaskDongguan Runlin Medical Supplies Technology Co., Ltd.20210—
+3K210023Surgical Face MaskGuangdong Winsun Personal Care Products Co.,Ltd20210—
+3K201924Single-Use Surgical MaskQiqihar Hengxin Medical Supplies, Ltd.20211—
+3K202548Surgical Face MaskWanxinda (Guangzhou) Technology Product Co., Ltd.20210—
+3K202710Disposable Medical Face MaskWanxinda (Guangzhou) Technology Product Co., Ltd.20210—
+3K202205Surgical Face MaskJiangsu Micsafe Medical Technology Co., Ltd.20210—
+3K202214IFM Surgical Mask Model SM3Fssc, LLC20210—
+3K201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3…Dukal Corporation20210—
+3K202107Medical Protective MaskGuangdong Kingfa Sci. & Tech.Co., Ltd.20211—
+3K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.2016158—
+4K250082Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20250—
+4K223823Disposable Surgical Face MaskEfofex, Inc.20231—
+4K221209PRECISION ECO Compostable / Plant Based Procedural Mask with EarloopsPadm Medical, Inc.20230—
+4K223232Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20231—
+4K223686Medical Protective MasksQinhuangdao Taizhi Medical Technology Co., Ltd.20230—
+4K220302Disposable surgical face maskShandong Aida Medical Products Co., Ltd.20220—