510(k) Report

Devices descending from K082258

299 later devices reach Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242502Aurelia Surgical Mask ASTM Level-3 (2130)Supermax Healthcare Canada – Supermax Medical20240—
+1K231005Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2Supermax Healthcare Canada-Supermax Medical20230—
+1K103150Kimberly-Clark Child/Pediatric Face MaskKimberly-Clark20116—
+1K110455Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp.2011289—
+2K232824FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White…Owens & Minor (O&M) Halyard, Inc.20240—
+2K232777FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender…Owens & Minor (O&M) Halyard, Inc.20241—
+2K232807Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869)…Owens & Minor (O&M) Halyard, Inc.20240—
+2K232806HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867)…Owens & Minor (O&M) Halyard, Inc.20240—
+2K232820HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)Owens & Minor (O&M) Halyard, Inc.20240—
+2K203528KNH Surgical Face MaskKnh Surgical Face Mask20220—
+2K213358Surgical MaskShenzhen Safesecure Medical Infection Control Tech Co., Ltd.20220—
+2K212264Surgical Face maskNantong Taiweishi Medical Technology Co., Ltd.20210—
+2K212368Surgical Face MaskAnhui Tiankang Medical Technology Co., Ltd.20214—
+2K210150Disposable Medical maskHubei Wanli Protective Products Co., Ltd.20211—
+2K210302Disposable Medical maskAnhui Jbh Medical Apparatus Co., Ltd.20210—
+2K202133Disposable Medical MaskHangzhou Qianzhiya Sanitary Products Co., Ltd.20210—
+2K202411Surgical MaskAllmed Medical Products Co., Ltd.20210—
+2K202137Disposable medical maskU-Play Products Corporation20211—
+2K201729Medical MaskZhende Medical Co., Ltd.20205—
+2K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd.201660—
+2K142990Insta-Gard Surgical and Procedure Face MaskCardinal Health200, LLC20151—
+2K131879KC 300 Surgical MaskKimberly-Clark Corp.20131851
+2K113340Kimberly-Clark Child's FacemaskKimberly-Clark20125—
+2K111402KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300…Kimberly-Clark2011262—
+3K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*…O&M Halyard, Inc.20260—
+3K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsO&M Halyard, Inc.20250—
+3K243010Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)…Owens & Minor (O&M) Halyard, Inc.20250—
+3K232812Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask…Owens & Minor (O&M) Halyard, Inc.20240—
+3K232968Grande Medical Masks, Model SF-600Golden Grande Corp.20240—
+3K222483Surgical Face MaskHubei Woozon Healthcare Co., Ltd.20230—
+3K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc.20220—
+3K222529Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.20220—
+3K221534Surgical Face Masks (Ear Loops And Tie-On)San-M Package Co., Ltd.20220—
+3K220944PointCore Surgical MaskPointcore, Inc.20220—
+3K221409Paneffort 3-ply Surgical and Procedural MasksPaneffort, LLC20220—
+3K220670MagnumMagnum Health and Safety Pvt, Ltd.20221—
+3K220377Procedure MaskLittle Rapids Corporation20220—
+3K214085Disposable Medical MaskHubei Wanli Protective Products Co., Ltd.20220—
+3K202903Surgical Face MaskRizhao Sanqi Medical & Health Articles Co., Ltd.20222—
+3K214087Medical Face MaskHubei Medlink Healthcare Co., Ltd.20222—
+3K212366Heartland Health Surgical MaskHeartland Health Products20220—
+3K212120Surgical MasksHubei Xinxin Non-Woven Co., Ltd.20221—
+3K210101American-Made Surgical MaskArmbrust, Inc.20220—
+3K212610Surgical Face MaskFoshan Nanhai Plus Medical Co, Ltd.20220—
+3K212994Medical Face MaskGuangzhou Quantum Laser Intelligent Equipment Co., Ltd.20220—
+3K212471Medical Face MaskHaian Medigauze Co., Ltd.20211—
+3K210222Disposable Medical MaskGuangdong Lide Medical Technology Co., Ltd.20210—
+3K210622Single-Use Medical Face MaskJiangxi Hongda Medical Equipment Group Co., Ltd.20211—
+3K211066Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask…Homtex, Inc.20210—
+3K211462Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face MaskXiantao S&J Protective Products Co., Ltd.20213—
+3K211454Surgical maskJiangsu Xingtong Biotechnology Group Co., Ltd.20212—
+3K210380Medical surgical maskShantou T&K Medical Equipment Factory Co.,Ltd20210—
+3K210524Surgical MaskChangzhou Holymed Products Co., Ltd.20210—
+3K210767Surgical Masks, Model:FE-1Hunan Triplex Precision Medical Devices Co., Ltd.20210—
+3K202128Allmed Surgical Face Masks (Ear loops)Allmed Medical Products Co., Ltd.20210—
+3K202697United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid…United Sewing Automation, Inc.20210—
+3K2025983 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3…3A Medical Products Co., Ltd.20211—
+3K202387Disposable Surgical Face MaskGuangdong Bida Medical Technology Co., Ltd.20210—
+3K202759Disposable medical surgical maskChongqing Coe Display Technology Co., Ltd.20210—
+3K201718GD Disposable Medical Face MaskJiangsu Guangda Medical Material Group Co., Ltd.20210—
+3K201127DEFEND Ear-loop Face MasksYoung Dental Manufacturing Co. 1, LLC20210—
+3K203012Surgical MaskCustomfab, Inc.20210—
+3K202424Surgical Mask-Models CR02-2, CR02Foshan Xinbao Technology Co., Ltd.20213—
+3K202708Surgical Face MasksIntco Medical (Hk) Co., Ltd.20210—
+3K202905Disposable Face MaskJiangsu Excellence Medical Supplies Co., Ltd.20211—
+3K203776Surgical Masks, Model SNN200640 & MN112Sq Medical Supplies, Inc.20210—
+3K203064ICU Health Surgical MaskPlastikon Industries20210—
+3K201624Spin Care Disposable Protective MaskSpintech, LLC20210—
+3K210225Surgical Face MaskFeng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd.20210—
+3K202240Disposable Surgical Mask/Fluid Resistant Procedure MaskLhm Medical Technology (Hong Kong) Limited20210—
+3K201868Phyziofit Medical Surgical MaskWellpower Sporting Goods Co., Ltd.20210—
+3K202341Disposable Surgical MaskShanghai Jianzhong Medical Packaging Co., Ltd.20210—
+3K203265nPro Surgical MaskNp Medical, Inc.20210—
+3K201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2…Dukal Corporation20210—
+3K202491Disposable Surgical Face MaskJiangsu Newvalue Medical Products Co., Ltd.20214—
+3K201754JianYu Surgical MaskJiangsu Jianyu Health Medical Co., Ltd.20200—
+3K202061Medical Face maskJiangsu Province Jianerkang Medical Dressing Co., Ltd.20202—
+3K201991Medical surgical maskShenzhen Everwin Precision Technology Co., Ltd.20200—
+3K1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask3M Healthcare201912—
+3K160100Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech20164—
+3K133070SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd.2015170—
+3K143287Fluidshield* Surgical Mask with Expanded ChamberHalyard Health, Inc.201510—
+3K140155Secure-Gard Surgical and Procedure Face MaskCardinal Health200, LLC20144—
+4K252650Disposable Medical Face MaskMakrite Industries, Inc.20260—
+4K251902Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield…Vitacore Industries, Inc.20250—
+4K232894HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining…Owens & Minor (O&M) Halyard, Inc.20240—
+4K221753Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd.20230—
+4K222545Disposable Medical MaskGuangzhou Fuzelong Hygiene Material Co., Ltd.20230—
+4K223236Medline Surgical Face Mask and Medline Procedural Face MaskMedline Industries, LP20230—
+4K221352Surgical Face MaskWuhan Huashida Protective Products Co., Ltd.20230—
+4K222809Medical Disposable Face MasksAnqing Mayfield Medical Limited20231—
+4K223068Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)Guangdong Golden Leaves Technology Development Co., Ltd.20220—
+4K222749High Fluid-Resistant Surgical and Procedure MaskAmerica’S Supply Chains20220—
+4K212926AllureTM Surgical MaskAllure Gift Wraps Private Limited20220—
+4K220067Medical Surgery Mask, Model:2626-7Dongguan Missadola Technology Co., Ltd.20220—
+4K211771The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical…The Good Corporation20220—
+4K221838Surgical Face Mask (HNFM0103)Shanghai Hua EN Industrial Co, Ltd.20220—
+4K220191Disposable Face MaskJiujiang Taixin Technology Co., Ltd.20220—
+4K220194Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20222—
+4K210321Dukal Corporation Level 1 Pediatric Face MaskDukal Corporation20221—