Models sold by EPC, including but not limited to, PT-N95F-01, PT-N95C-02, and PT-N95CS-02 are NOT NIOSH approved. 18, IstTongLe Road, TangXia Town, PengJiang District, JiangMen, GuangDong, China +86-750-2633805 . to us. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. KN95 Face Mask | GB2626-2006 Standard | Mask By Whizley Jiangsu Weichuangli New Materials Co., Ltd. Jiangxi Yifengyuan Biological Engineering Co., Ltd. Juntech (Jiaxing) Healthcare Materials Co. Ltd. Panzhihua Gangcheng Group Yasheng Industrial Co., Ltd. Qingdao Orphila Medical Technology Co. LTD. Qingyuan Leite Technology Development Co. Shandong Daddy's Choice Health Science and Technology Co., Ltd. Shauguan Taijie Protection Technology Co. Ltd. Shenzhen Missadola Technology Co., Ltd, dba 1AK Medical Supplies, Sunright Medical Technology (GuangDong) Co., LTD. Tianjin Benmo Medical Equipment Co., Ltd. Zhejiang Baiyi Intelligent Garment Co LTD. Zhengzhou Wanshenshan Healthcare PPE Co., Ltd. Fujian Kang Chen Daily Necessities Co, Ltd. Rose Personal Protective Equipment Industry and Trade Anonym Company, Medimask MM-001, MM-002, MM-003 A, MM-003 B, MM-003 C, MM-003 D, MM-003 E, MM-003 F, MM-003 G, MM-003 H, MM-003 I, MM-003 J, MM-003 K, MM-003 L, MM-004 A, MM-004 B, MM-004 C, MM-004 D, MM-004 E, MM-004 F, MM-004 G, MM-004 H, MM-004 I, MM-004 J, MM-004 K, and MM-004 L, Tenamyd FM-N95 Model YCKTC13, Tenafa N-95 Model YCTFA04, Tenami N-95 Model YCTM102, YCTFM02, YCTFA07, YCTMI08, YCTFM01, YCTFA06, YCTMI07, MUSK Medikal Tekstil Plastik Sanayi Ve Ticaret Limited Sirketi. Standard: GB2626-2019.KN95. If the mask you purchased is past its expiration date, you may not be protected. A real KF94 is made in South Korea, and a KN95 made according to the latest standards should be stamped with "GB2626-2019," Wirecutter reports. U-SAFE models B120 and B130 N95 particulate respirator are not NIOSH approved. The product package indicates it meets Chinese standard GB 2626-2006 and submitted to NIOSH under an International Respirator Assessment request. FDA Advisory No. 2020-2040 - Food and Drug Administration They help us to know which pages are the most and least popular and see how visitors move around the site. Masks are disposable and cannot be washed or reused. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. (11/5/2021), This is an example of a misrepresentation of a NIOSH approval. hVQo6+|l2HJ@v,s#TI0jm$ww`4c You should not wear international respirators with exhalation valves or vents, either, according to the CDC this guidance applies to all masks. NIOSH approved products satisfy the NIOSH regulatory requirements set forth in 42 C.F.R. Though experts told us this is better to have than not, FDA registration has no bearing on the quality of the face mask itself and does not denote approval of the mask or its manufacturer by the FDA. They also include an adjustable nose bridge and adjustable ear loops. The KN95 filtering facepiece respirators are also used by healthcare professionals, since the masks were approved by the FDA, according to the FDA guidelines and international standards. During this point of the pandemic, masks such as N95 are more readily available for the general population and are no longer limited to just healthcare professionals. NIOSH received notice of a counterfeit N95 Respirator. Neither Pangolin nor Pangocare is a NIOSH approval holder or a private label holder. In their guide to masks and respirators, the CDC further prioritized respirators above masks with emphasis on a proper fit and specified theyre better than cloth products. G & F Products is not a NIOSH approval holder or a private label holder. As the federal entity responsible for the Respirator Approval Program, NIOSH is the custodian of these certification marks. While the CDC doesnt provide specific regulations to follow when it comes to choosing a KN95 mask, they do offer a list of factors to consider when purchasing an international respirator like a KN95, as well as a list of tips to help you spot masks that may not meet the necessary standards. (11/6/2019), Images here are examples of counterfeit respirators and sold as if they are NIOSH approved. Chengde Technology Co., Ltd. is not a NIOSH approval holder or a private label holder. Web links in the table go to the NIOSH Approval Holders website. Although they appear to be from NIOSH, these documents include alterations and false information. The CDC has provided a visual aid for NIOSH-approved N95 respirators. PROTECTIVE FACE MASK Expiry Date: 2 years Standard :GB2626-2006 (Non-Medical Device) Manufacturer:SILVERFOX CORPORATION LIMITED Manufacturing Address: No. See the Notes section for information about private labels. This item: Kingfa KN95 Face Mask 50 Pcs Disposable Respirator 5-Ply Layer | GB2626-2019 Compliant $14.99 ($0.30/Count) Hotodeal KN95 Face Mask 20 PCS,5 Layers Cup Dust Mask Against PM2.5 from Fire Smoke, Dust, for Men, Women, Essential Workers (Grey) $19.99 ($1.00/Count) Lu'an Bi Hai Protective Equipment Co., Ltd. Naton Medical Protective Mask (Zhuozhou) Co., Ltd, FS9501-L, FS9501-M, FS9501-S; FS9901-L, FS9901-M, FS9901-S, DONGGUAN AOXING AUDIO VISUAL EQUIPMENT CO.,LTD. SAS allowed private labeling for this model until SAS voluntarily rescinded the NIOSH approval in 2014. (4/28/2020), NIOSH did not issue this letter and test report to Shenzhen Ende Medical Technology Co., Ltd. NIOSH does not approve KN95 products or any other respiratory protective devices certified to international standards. Before you use a specific public transportation system in your area, be sure to double-check its mask requirements as they can change at any time. The NIOSH stylized logo is a registered certification mark owned by HHS. The NIOSH website statesmanufacturers, distributors, suppliers, and importers cannot use these results to make claims about their products. Additionally, the TC number belongs to a 3M full facepiece respirator with cartridges. Don't use a mask with damaged packaging for your own safety. The fastener connects the loops behind the head. Evolvetogethers KN95 masks come in a pack of five and are individually wrapped in what the company has said are biodegradable pouches. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. The N95 respirator is the most common of the seven types of particulate filtering facepiece respirators. On March 28, 2020, FDA revised this EUA to authorize the use of certain authorized respirators that have been decontaminated pursuant to the terms and conditions of an authorized decontamination system. KN95 respiratory masks are masks that are regulated by the Chinese government under regulations GB2626-2006, GB262-2019, and GB19083-2010. The 8 Best Face Masks of 2023 | by Health 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9480V (FFP2). PDF NPPTL COVID-19 Response: International Respirator Assessment, Kingfa - CDC The Model Number/Product Line in bold text followed by (FDA) indicates these surgical N95 respirators in the table below. Catch up on Select's in-depth coverage of personal finance, tech and tools, wellness and more, and follow us on Facebook, Instagram and Twitter to stay up to date. Many shoppers have noted how well the mask can be molded to properly fit their faces. NIOSH successfully registered the NIOSH stylized logos with the U.S. Patent and Trademark Office (USPTO). SafeShields marketing of model FS-N95 is misleading and may cause users to believe it is NIOSH approved. Amazon.com: Customer reviews: Kingfa KN95 Face Mask 50 Pcs Disposable Use of face masks designated KN95 - Safety alert - HSE Pasture Pharma did not manufacture this counterfeit respirator. And the adjustable nose wire and ear straps help avoid irritation on kids sensitive skin. Anyone claiming that they have authorization or a purchase contract with Makrite Hubei Industrial Co., Ltd is forgery and infringement. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. The Moaron 2091 P100 filter is NOT a component associated with a NIOSH approval. Read honest and unbiased product reviews from . Part 84. On March 24, 2021, the FDA revised this EUA to authorize for emergency use only those respirators listed in the EUA's Exhibit 1 as of the date of this reissuance. (2/4/2021), This is an example of a misrepresentation of a NIOSH approved product. (9/9/2021), Moaron is NOT a NIOSH approval holder, and they are misrepresenting product as meeting NIOSH approval. Why We Like It: The shape naturally conforms to the wearers face to allow for comfortable talking and facial movement. However, the manufacturer, Zubi-Ola, is not a NIOSH approval holder or a private label holder. You can find a specific manufacturer by clicking on the first letter of their name on the index below. These KN95 masks were featured on the FDAs EUA list. At Select, we work with experts who have specialized knowledge and authority based on relevant training and/or experience. Previously FDA-Approved KN95 Face Masks. The ear loop of this mask is made of a highly stretchable soft material that is latex-free. Each has six layers and an adjustable nose bridge. The CDC also has a list of NIOSH-approved. NIOSH also provides a table of the surgical N95 respirators approved prior to the MOU. NIOSH National Personal Protective Technology Laboratory. Yamada brand masks, including models 5241 and 8242, are not NIOSH approved. Why We Like it: It filters out more than 98 percent of airborne particles and is made in the United States. CDC twenty four seven. For more information, view the NIOSH Conformity Assessment Letter to Manufacturers, NIOSH CA 2022-1041R1. Dongguan AOXING is not a NIOSH approval holder or a private label assignee. The masks have an adjustable nose bridge, and you can purchase as few as 10 masks, which come individually wrapped. Search for NIOSH Approved respirators. They come in a pack of 25 and are available in multiple colors. Parents will love that the mask has a 95 percent filtration rate and can be reused up to 50 times. Please provide the following details with your email: The NIOSH stylized logos (shown below), N99, N100, R95, P95, P100, PAPR100-N, PAPR100-P, and HE are certification marks of the U.S. Department of Health and Human Services (HHS) registered in the United States. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. For an optimal experience visit our site on another browser. (1/11/2022), Guangzhou Zhen Tao Culture Media Co., Ltd. is marketing Benehal Model 8865 as a NIOSH Approved respirator for kids. Huizhou Yibaidu Medical Device Technology Co., Ltd. XIAMEN LIANYI INDUDSTIRAL & TRADING CO., LTD. Qingdao Bioforce-aid Technology Co., Ltd. Xiamen Chengchuang Automotive Materials Co., Ltd. Foshan Nanhai Chuanzhishang Clothing Co., LTD. Hangzhou Gang Yu Health Products Co., Ltd. Jiangsu Kangershun Protective Equipment Co., Ltd. ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD. Each mask features five layers for ample protection. The soft inner lining is designed for comfort and to keep your face cool and moisture free. To determine your areas Covid-19 Community Level, use the CDC's Covid-19 county check. However, note the misspelling of NIOSH on the front of the respirator. These links do not constitute an endorsement of their content, or a statement of NIOSH policy. endstream endobj 1954 0 obj <>/Metadata 357 0 R/OCProperties<>/OCGs[1962 0 R]>>/Outlines 478 0 R/PageLayout/SinglePage/Pages 1945 0 R/StructTreeRoot 541 0 R/Type/Catalog/ViewerPreferences<>>> endobj 1955 0 obj <>/ExtGState<>/Font<>/Properties<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Trans 1970 0 R/Type/Page>> endobj 1956 0 obj <>stream The NIOSH website states manufacturers, distributors, suppliers, and importers cannot use to make claims about their products. However, the manufacturer, Anhui Tongcheng YaGe Health Materials, Co., Ltd, is not a NIOSH approval holder. They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. (1/18/2022), Good Mask Co. is misusing NIOSH test information regarding the Good Folding KN95 mask; marketing as CDC-approved, NIOSH-certified.This statement is misleading because CDC, through NIOSH, does not approve KN95 masks. This information is inaccurate. ZHEJIANG LUYAO ELECTRONICS TECHNOLOGY CO., LTD. Chongqing Zisun (Zaisheng) Technology Corp., Ltd. Shandong Haidike Medical Products Co., Ltd. Anhui Zhongke Duling Commercial Appliance Co. Ltd. Guangdong Zhizhen Biological Medicine Co., Ltd. KN95 Three-Dimensional Protective Face Mask.
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