510(k) Report

Devices descending from K874608

331 later devices reach Tecnol Fluid Shield Surgical Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K955557Fluid Reisistant Eyeshield MaskAmerican Threshold Healthcare19960—
+1K955556Fluid Resistant MaskAmerican Threshold Healthcare1996329—
+2K082258Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with…Crosstex International2008299—
+2K012602Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face…Crosstex Intl.200228—
+3K242502Aurelia Surgical Mask ASTM Level-3 (2130)Supermax Healthcare Canada – Supermax Medical20240—
+3K231005Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2Supermax Healthcare Canada-Supermax Medical20230—
+3K103150Kimberly-Clark Child/Pediatric Face MaskKimberly-Clark20116—
+3K110455Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp.2011289—
+3K100846Imc Surgical Face MaskInternational Medsurg Connection20103—
+3K092580Tidi FacemaskTidi Products,Llc20109—
+3K050689Surgical Face MaskChina Surgical Dressings Center Co., Ltd.20050—
+3K040333Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or Without…Valumax Intl., Inc.200421—
+3K023755Winner Ear Loop Procedure Mask, Tie-on Surgical Mask & Ear Loop Procedure Mask with ShieldWinner Industries (Shenzhen) Co., Ltd.20030—
+4K232824FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White…Owens & Minor (O&M) Halyard, Inc.20240—
+4K232777FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender…Owens & Minor (O&M) Halyard, Inc.20241—
+4K232807Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869)…Owens & Minor (O&M) Halyard, Inc.20240—
+4K232806HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867)…Owens & Minor (O&M) Halyard, Inc.20240—
+4K232820HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)Owens & Minor (O&M) Halyard, Inc.20240—
+4K203528KNH Surgical Face MaskKnh Surgical Face Mask20220—
+4K213358Surgical MaskShenzhen Safesecure Medical Infection Control Tech Co., Ltd.20220—
+4K212375Disposable Medical Surgical MaskJiangxi Bestgrand Health Technology Co., Ltd.20220—
+4K212264Surgical Face maskNantong Taiweishi Medical Technology Co., Ltd.20210—
+4K212368Surgical Face MaskAnhui Tiankang Medical Technology Co., Ltd.20214—
+4K202954Disposable Surgical MaskXiamen Probtain Medical Techology Co., Ltd.20210—
+4K210429Disposable Surgical Face MaskJiangxi Heying Pharmaceutical Co., Ltd.20210—
+4K210150Disposable Medical maskHubei Wanli Protective Products Co., Ltd.20211—
+4K210302Disposable Medical maskAnhui Jbh Medical Apparatus Co., Ltd.20210—
+4K202133Disposable Medical MaskHangzhou Qianzhiya Sanitary Products Co., Ltd.20210—
+4K202411Surgical MaskAllmed Medical Products Co., Ltd.20210—
+4K202137Disposable medical maskU-Play Products Corporation20211—
+4K201729Medical MaskZhende Medical Co., Ltd.20205—
+4K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd.201660—
+4K141875Pasture 60S Surgical MaskPasture Pharma Pte, Ltd.20153—
+4K142990Insta-Gard Surgical and Procedure Face MaskCardinal Health200, LLC20151—
+4K131879KC 300 Surgical MaskKimberly-Clark Corp.20131851
+4K113340Kimberly-Clark Child's FacemaskKimberly-Clark20125—
+4K111402KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300…Kimberly-Clark2011262—
+4K093179Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)H&H Research Company20103—
+4K100800Tidi FacemaskTidi Products,Llc20100—
+4K061864Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560Dukal Corp.20066—
+4K051291Non-Sterile Surgical MaskA.R. Medicom, Inc.2005205
+5K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*…O&M Halyard, Inc.20260—
+5K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsO&M Halyard, Inc.20250—
+5K243010Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)…Owens & Minor (O&M) Halyard, Inc.20250—
+5K232812Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask…Owens & Minor (O&M) Halyard, Inc.20240—
+5K232968Grande Medical Masks, Model SF-600Golden Grande Corp.20240—
+5K222483Surgical Face MaskHubei Woozon Healthcare Co., Ltd.20230—
+5K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc.20220—
+5K222529Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.20220—
+5K221534Surgical Face Masks (Ear Loops And Tie-On)San-M Package Co., Ltd.20220—
+5K220944PointCore Surgical MaskPointcore, Inc.20220—
+5K212273Cross Protection ResQ300 Plus Surgical Face MaskCross Protection (M) Sdn Bhd20220—
+5K221409Paneffort 3-ply Surgical and Procedural MasksPaneffort, LLC20220—
+5K220670MagnumMagnum Health and Safety Pvt, Ltd.20221—
+5K220377Procedure MaskLittle Rapids Corporation20220—
+5K214085Disposable Medical MaskHubei Wanli Protective Products Co., Ltd.20220—
+5K202903Surgical Face MaskRizhao Sanqi Medical & Health Articles Co., Ltd.20222—
+5K214087Medical Face MaskHubei Medlink Healthcare Co., Ltd.20222—
+5K212366Heartland Health Surgical MaskHeartland Health Products20220—
+5K212120Surgical MasksHubei Xinxin Non-Woven Co., Ltd.20221—
+5K210101American-Made Surgical MaskArmbrust, Inc.20220—
+5K212610Surgical Face MaskFoshan Nanhai Plus Medical Co, Ltd.20220—
+5K212994Medical Face MaskGuangzhou Quantum Laser Intelligent Equipment Co., Ltd.20220—
+5K212471Medical Face MaskHaian Medigauze Co., Ltd.20211—
+5K210222Disposable Medical MaskGuangdong Lide Medical Technology Co., Ltd.20210—
+5K210622Single-Use Medical Face MaskJiangxi Hongda Medical Equipment Group Co., Ltd.20211—
+5K211066Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask…Homtex, Inc.20210—
+5K211462Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face MaskXiantao S&J Protective Products Co., Ltd.20213—
+5K211454Surgical maskJiangsu Xingtong Biotechnology Group Co., Ltd.20212—
+5K210380Medical surgical maskShantou T&K Medical Equipment Factory Co.,Ltd20210—
+5K210524Surgical MaskChangzhou Holymed Products Co., Ltd.20210—
+5K210767Surgical Masks, Model:FE-1Hunan Triplex Precision Medical Devices Co., Ltd.20210—
+5K202128Allmed Surgical Face Masks (Ear loops)Allmed Medical Products Co., Ltd.20210—
+5K202697United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid…United Sewing Automation, Inc.20210—
+5K2025983 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3…3A Medical Products Co., Ltd.20211—
+5K202387Disposable Surgical Face MaskGuangdong Bida Medical Technology Co., Ltd.20210—
+5K202759Disposable medical surgical maskChongqing Coe Display Technology Co., Ltd.20210—
+5K201718GD Disposable Medical Face MaskJiangsu Guangda Medical Material Group Co., Ltd.20210—
+5K201127DEFEND Ear-loop Face MasksYoung Dental Manufacturing Co. 1, LLC20210—
+5K203012Surgical MaskCustomfab, Inc.20210—
+5K202424Surgical Mask-Models CR02-2, CR02Foshan Xinbao Technology Co., Ltd.20213—
+5K202708Surgical Face MasksIntco Medical (Hk) Co., Ltd.20210—
+5K202905Disposable Face MaskJiangsu Excellence Medical Supplies Co., Ltd.20211—
+5K203776Surgical Masks, Model SNN200640 & MN112Sq Medical Supplies, Inc.20210—
+5K203064ICU Health Surgical MaskPlastikon Industries20210—
+5K201624Spin Care Disposable Protective MaskSpintech, LLC20210—
+5K203425Surgical MaskBdc Dental Corporation, Ltd.20210—
+5K210225Surgical Face MaskFeng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd.20210—
+5K202240Disposable Surgical Mask/Fluid Resistant Procedure MaskLhm Medical Technology (Hong Kong) Limited20210—
+5K201868Phyziofit Medical Surgical MaskWellpower Sporting Goods Co., Ltd.20210—
+5K202341Disposable Surgical MaskShanghai Jianzhong Medical Packaging Co., Ltd.20210—
+5K203265nPro Surgical MaskNp Medical, Inc.20210—
+5K201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2…Dukal Corporation20210—
+5K202577Medical Surgical Mask-Model MP002-5, MP002-6Jiangmen Sure&Me Medical Product Co., Ltd.20210—
+5K202491Disposable Surgical Face MaskJiangsu Newvalue Medical Products Co., Ltd.20214—
+5K201754JianYu Surgical MaskJiangsu Jianyu Health Medical Co., Ltd.20200—
+5K202061Medical Face maskJiangsu Province Jianerkang Medical Dressing Co., Ltd.20202—
+5K201991Medical surgical maskShenzhen Everwin Precision Technology Co., Ltd.20200—
+5K202139Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd.20201—
+5K1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask3M Healthcare201912—