510(k) Report

Devices descending from K801036

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082258Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with…Crosstex International2008299—
+1K012602Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face…Crosstex Intl.200228—
+2K242502Aurelia Surgical Mask ASTM Level-3 (2130)Supermax Healthcare Canada – Supermax Medical20240—
+2K231005Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2Supermax Healthcare Canada-Supermax Medical20230—
+2K103150Kimberly-Clark Child/Pediatric Face MaskKimberly-Clark20116—
+2K110455Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp.2011289—
+2K100846Imc Surgical Face MaskInternational Medsurg Connection20103—
+2K092580Tidi FacemaskTidi Products,Llc20109—
+2K050689Surgical Face MaskChina Surgical Dressings Center Co., Ltd.20050—
+2K040333Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or Without…Valumax Intl., Inc.200421—
+2K023755Winner Ear Loop Procedure Mask, Tie-on Surgical Mask & Ear Loop Procedure Mask with ShieldWinner Industries (Shenzhen) Co., Ltd.20030—
+3K232824FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White…Owens & Minor (O&M) Halyard, Inc.20240—
+3K232777FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender…Owens & Minor (O&M) Halyard, Inc.20241—
+3K232807Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869)…Owens & Minor (O&M) Halyard, Inc.20240—
+3K232806HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867)…Owens & Minor (O&M) Halyard, Inc.20240—
+3K232820HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)Owens & Minor (O&M) Halyard, Inc.20240—
+3K203528KNH Surgical Face MaskKnh Surgical Face Mask20220—
+3K213358Surgical MaskShenzhen Safesecure Medical Infection Control Tech Co., Ltd.20220—
+3K212375Disposable Medical Surgical MaskJiangxi Bestgrand Health Technology Co., Ltd.20220—
+3K212264Surgical Face maskNantong Taiweishi Medical Technology Co., Ltd.20210—
+3K212368Surgical Face MaskAnhui Tiankang Medical Technology Co., Ltd.20214—
+3K202954Disposable Surgical MaskXiamen Probtain Medical Techology Co., Ltd.20210—
+3K210429Disposable Surgical Face MaskJiangxi Heying Pharmaceutical Co., Ltd.20210—
+3K210150Disposable Medical maskHubei Wanli Protective Products Co., Ltd.20211—
+3K210302Disposable Medical maskAnhui Jbh Medical Apparatus Co., Ltd.20210—
+3K202133Disposable Medical MaskHangzhou Qianzhiya Sanitary Products Co., Ltd.20210—
+3K202411Surgical MaskAllmed Medical Products Co., Ltd.20210—
+3K202137Disposable medical maskU-Play Products Corporation20211—
+3K201729Medical MaskZhende Medical Co., Ltd.20205—
+3K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd.201660—
+3K141875Pasture 60S Surgical MaskPasture Pharma Pte, Ltd.20153—
+3K142990Insta-Gard Surgical and Procedure Face MaskCardinal Health200, LLC20151—
+3K131879KC 300 Surgical MaskKimberly-Clark Corp.20131851
+3K113340Kimberly-Clark Child's FacemaskKimberly-Clark20125—
+3K111402KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300…Kimberly-Clark2011262—
+3K093179Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)H&H Research Company20103—
+3K100800Tidi FacemaskTidi Products,Llc20100—
+3K061864Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560Dukal Corp.20066—
+3K051291Non-Sterile Surgical MaskA.R. Medicom, Inc.2005205
+4K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*…O&M Halyard, Inc.20260—
+4K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsO&M Halyard, Inc.20250—
+4K243010Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)…Owens & Minor (O&M) Halyard, Inc.20250—
+4K232812Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask…Owens & Minor (O&M) Halyard, Inc.20240—
+4K232968Grande Medical Masks, Model SF-600Golden Grande Corp.20240—
+4K222483Surgical Face MaskHubei Woozon Healthcare Co., Ltd.20230—
+4K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc.20220—
+4K222529Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.20220—
+4K221534Surgical Face Masks (Ear Loops And Tie-On)San-M Package Co., Ltd.20220—
+4K220944PointCore Surgical MaskPointcore, Inc.20220—
+4K212273Cross Protection ResQ300 Plus Surgical Face MaskCross Protection (M) Sdn Bhd20220—
+4K221409Paneffort 3-ply Surgical and Procedural MasksPaneffort, LLC20220—
+4K220670MagnumMagnum Health and Safety Pvt, Ltd.20221—
+4K220377Procedure MaskLittle Rapids Corporation20220—
+4K214085Disposable Medical MaskHubei Wanli Protective Products Co., Ltd.20220—
+4K202903Surgical Face MaskRizhao Sanqi Medical & Health Articles Co., Ltd.20222—
+4K214087Medical Face MaskHubei Medlink Healthcare Co., Ltd.20222—
+4K212366Heartland Health Surgical MaskHeartland Health Products20220—
+4K212120Surgical MasksHubei Xinxin Non-Woven Co., Ltd.20221—
+4K210101American-Made Surgical MaskArmbrust, Inc.20220—
+4K212610Surgical Face MaskFoshan Nanhai Plus Medical Co, Ltd.20220—
+4K212994Medical Face MaskGuangzhou Quantum Laser Intelligent Equipment Co., Ltd.20220—
+4K212471Medical Face MaskHaian Medigauze Co., Ltd.20211—
+4K210222Disposable Medical MaskGuangdong Lide Medical Technology Co., Ltd.20210—
+4K210622Single-Use Medical Face MaskJiangxi Hongda Medical Equipment Group Co., Ltd.20211—
+4K211066Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask…Homtex, Inc.20210—
+4K211462Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face MaskXiantao S&J Protective Products Co., Ltd.20213—
+4K211454Surgical maskJiangsu Xingtong Biotechnology Group Co., Ltd.20212—
+4K210380Medical surgical maskShantou T&K Medical Equipment Factory Co.,Ltd20210—
+4K210524Surgical MaskChangzhou Holymed Products Co., Ltd.20210—
+4K210767Surgical Masks, Model:FE-1Hunan Triplex Precision Medical Devices Co., Ltd.20210—
+4K202128Allmed Surgical Face Masks (Ear loops)Allmed Medical Products Co., Ltd.20210—
+4K202697United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid…United Sewing Automation, Inc.20210—
+4K2025983 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3…3A Medical Products Co., Ltd.20211—
+4K202387Disposable Surgical Face MaskGuangdong Bida Medical Technology Co., Ltd.20210—
+4K202759Disposable medical surgical maskChongqing Coe Display Technology Co., Ltd.20210—
+4K201718GD Disposable Medical Face MaskJiangsu Guangda Medical Material Group Co., Ltd.20210—
+4K201127DEFEND Ear-loop Face MasksYoung Dental Manufacturing Co. 1, LLC20210—
+4K203012Surgical MaskCustomfab, Inc.20210—
+4K202424Surgical Mask-Models CR02-2, CR02Foshan Xinbao Technology Co., Ltd.20213—
+4K202708Surgical Face MasksIntco Medical (Hk) Co., Ltd.20210—
+4K202905Disposable Face MaskJiangsu Excellence Medical Supplies Co., Ltd.20211—
+4K203776Surgical Masks, Model SNN200640 & MN112Sq Medical Supplies, Inc.20210—
+4K203064ICU Health Surgical MaskPlastikon Industries20210—
+4K201624Spin Care Disposable Protective MaskSpintech, LLC20210—
+4K203425Surgical MaskBdc Dental Corporation, Ltd.20210—
+4K210225Surgical Face MaskFeng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd.20210—
+4K202240Disposable Surgical Mask/Fluid Resistant Procedure MaskLhm Medical Technology (Hong Kong) Limited20210—
+4K201868Phyziofit Medical Surgical MaskWellpower Sporting Goods Co., Ltd.20210—
+4K202341Disposable Surgical MaskShanghai Jianzhong Medical Packaging Co., Ltd.20210—
+4K203265nPro Surgical MaskNp Medical, Inc.20210—
+4K201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2…Dukal Corporation20210—
+4K202577Medical Surgical Mask-Model MP002-5, MP002-6Jiangmen Sure&Me Medical Product Co., Ltd.20210—
+4K202491Disposable Surgical Face MaskJiangsu Newvalue Medical Products Co., Ltd.20214—
+4K201754JianYu Surgical MaskJiangsu Jianyu Health Medical Co., Ltd.20200—
+4K202061Medical Face maskJiangsu Province Jianerkang Medical Dressing Co., Ltd.20202—
+4K201991Medical surgical maskShenzhen Everwin Precision Technology Co., Ltd.20200—
+4K202139Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd.20201—
+4K1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask3M Healthcare201912—
+4K160100Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech20164—
+4K152197Skypro, SP01 MaskSkypro Medical Supplies Company20162—