Another thing to look for: The packaging must indicate the manufacturing date. 0e$Yp59 Why We Like it: These disposable surgical masks are made in the United States. Each of the following masks have features that align with expert guidance and our research: Five or more layers, 95% filtration (or above) and ear loops. Check out more tips to spot counterfeit respirators. These NIOSH-approved surgical N95 respirators are only on the Certified Equipment List (CEL). Pairon Solutions LLC - 616392 - 08/09/2021 | FDA If the mask you purchased is past its expiration date, you may not be protected. Previously FDA-Approved KN95 Face Masks. Misrepresented respirators include all respirators that are falsely marketed and sold as NIOSH Approved respirators when they are not. On June 30, 2021, the FDA announced the revocation of the following EUAs: As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. NIOSH approved products satisfy the NIOSH regulatory requirements set forth in 42 C.F.R. Based on a comparison from 3M, it is reasonable to consider China KN95, AS/NZ P2, Korea 1st Class, and Japan DS FFRs as "equivalent" to US NIOSH N95 and European FFP2 respirators, for filtering non-oil-based particles . (1/26/2022), Chengde Technology Co., Ltd. is misusing NIOSH test information regarding Gosbuy KN95 face masks. FDA Advisory No. 2020-2040 - Food and Drug Administration U-SAFE does not have permission to use this certification mark because this is not a NIOSH Approved respirator. Zhengzhou Ruipu Medical Technology Co., Ltd. is not a NIOSH approval holder or a private label holder. However, the manufacturer, Anhui Tongcheng YaGe Health Materials, Co., Ltd, is not a NIOSH approval holder. 2020-2040 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product "FFP2 PROTECTIVE MASK GB2626-2006 (CIVIL GRADE) 5 LAYERS KN95" (3/12/2020), This is an example of a misrepresentation of the NIOSH approval. g1>Es}( 4 Pz:GH (11/5/2021), Dongguan AOXING is misusing NIOSH test information for its KN95 Protective Mask model AX-KF95. Masks absolutely have expiration dates. The agency said disposable surgical masks and reusable cloth masks offer less protection. You can find out more about our use, change your default settings, and withdraw your consent at any time with effect for the future by visiting Cookies Settings, which can also be found in the footer of the site. The KN95 mask could be an effective method of protection against airborne pathogens. All respirator shipments from China that came into the U.S. were subject to random sampling and testing by CDC's NIOSH to determine whether the respirator meets the expected particulate filtration standards. Greater than 95% filtration efficiency: to effectively protect respiratory health. Health Protective advertises the KN95 mask using results from the assessment. On June 6, 2020, the FDA further revised the Scope of Authorization of this EUA, including, among other changes, further revision to the eligibility criteria to provide additional specificity regarding the jurisdictions eligible for review and to remove decontaminated respirators from the scope of authorized products such that authorized respirator models listed in Appendix A are not authorized if they are decontaminated. According to Dr. Gandhi, masks work on an individual level as long as the individual is properly wearing the face mask. However, you dont have to toss a KN95 mask after a single use. 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. 1. (2/19/2019). If the KN95 was produced before July 1, 2021, marking as "GB2626-2006 KN95" is acceptable. . Shining Star Electronic Technology Co., Ltd. Shanghai Gangkai Purifying Products Company, Ltd. MSA do Brasil Equipamentos e Instrumentos de Seguranca Ltd.a. The FDA will still consider KN95 respirators medical devices equivalent to N95s (as the FDA and U.S. Centers for Disease Control and Prevention (CDC) consider GB2626-2019 to be equivalent to NIOSH N95) but authorization for KN95 respirators will require additional validation and review by the FDA. Additionally, GB2626-2019 is the mandatory standard for respiratory protection masks. La Forte brand masks are not NIOSH approved. NIOSH successfully registered the NIOSH stylized logos with the U.S. Patent and Trademark Office (USPTO). Additionally, Health Protective is misusing NIOSH test information. Why We Like It: These masks can be sent back to the company when youre done using them and the company will recycle them. KN95 Protective Face Mask GB2626 Standard (5-Pack) - The Home Depot The brand of mask should be visible somewhere on the mask itself. If so, it will void the NIOSH approval. Huizhou Green Communication Equipment Manufacturing Co., Ltd. is not a NIOSH approval holder or a private label assignee. Although Kingfa has products listed on the FDA website as approved for use in the US under the EUA, those are for models: KF-A F01 and KF-A . Use of face masks designated KN95 - Safety alert - HSE Here, a cheat sheet of the different levels of protection offered by different masks and respirators: If youre wondering how to navigate the process of buying KN95 respirators, we talked to medical experts about who will benefit most by using them, when to wear them and how to shop for them. The NIOSH stylized logo is a registered certification mark owned by HHS. The experts we spoke with included: Julie Chen, MD, an integrative medicine physician who is board-certified in internal medicine, Monica Gandhi, MD, MPH, Director of UCSF-Bay Area Center for AIDS Research (CFAR). A KN95 mask should not be damaged in any way, Packaging should never include false claims or logos from the FDA. A KN95 mask can be worn multiple times If you remove and store it properly. Thank you for taking the time to confirm your preferences. TC-84A-8125 is a valid NIOSH approval number. Revoked EUAs for Non-NIOSH-Approved Disposable FFRs endstream endobj 1958 0 obj <>stream Julie Chen, MD, an integrative medicine physician who is board-certified in internal medicine, says these masks are made from "multiple layers of material that block 95 percent of 0.3 micron particles. ), SKIP AHEAD What is a KN95 mask? And the adjustable nose wire and ear straps help avoid irritation on kids sensitive skin. KN95 masks are disposable face coverings, so you cant wash and reuse them like you can a cloth mask. Read honest and unbiased product reviews from . These are examples of counterfeit respirators. You may be able to find the same content in another format, or you may be able to find more information, at their web site. Pure&Safe does not have permission to use this certification mark because this is not a NIOSH Approved respirator. Anhui Zhongke Duling Commercial Appliance Co. Ltd. Guangdong Zhizhen Biological Medicine Co., Ltd. KN95 Three-Dimensional Protective Face Mask. to us. N95 is a registered certification mark owned by HHS. The NIOSH stylized logo is a registered certification mark owned by HHS. All masks fit differently, and features like adjustable ear loops and an adjustable nose bridge help you improve the fit of your mask, as do mask fitters or braces, according to the CDC. How effective are N95 face masks against COVID-19? Zhengzhou Ruipu Medical Technology Co., Ltd. advertises the product using results from the assessment. 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. Nor are they a private label holder. (4/28/2020), NIOSH did not issue this letter and test report to Shenzhen Ende Medical Technology Co., Ltd. Her work has appeared in Mens Health, Health Magazine, and SELF.com. The softer pouch style of this NIOSH-approved N95 mask provides a lighter and more comfortable wear than the traditional cup-shaped N95 masks, which makes it great for traveling, The design of the mask makes it easier to breathe while still forming a seal around the nose and mouth to help protect the wearer. They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. Additionally, Good Mask Co. is misusing NIOSH test information. Counterfeit Respirators | NPPTL | NIOSH | CDC Before sharing sensitive information, make sure you're on a federal government site. Its difficult, sometimes impossible, to be sure youre really buying a KN95 mask just by looking at it, said Dr. Jeremy Friese, a former Mayo Clinic physician and the former president of the payer market at Olive, an Ohio-based company that integrates artificial intelligence into health care. These companies cannot use this certification mark because this is not a NIOSH Approved respirator. Chengde Technology Co., Ltd. is not a NIOSH approval holder or a private label assignee. PDF NPPTL COVID-19 Response: International Respirator Assessment, Kingfa - CDC 17 with code SELECT20. The product package indicates it meets Chinese standard GB 2626-2019 and submitted to NIOSH under an International Respirator Assessment request. Personal Protective Equipment EUAs | FDA It later ended the EUA because NIOSH-approved respirators were no longer in short supply. The NIOSH website statesmanufacturers, distributors, suppliers, and importers cannot use these results to make claims about their products. Previously reported by Men's Health, the CDC is warning against several N95 respirators falsely claiming to be approved by NIOSH flooding the market, and therefore won't effectively protect you from COVID-19, especially the Omicron variant, spread. This counterfeit respirator uses NIOSH approval holder Shining Star Electronic Technologys NIOSH approval number (TC-84A-8125, model SS6001-N95) without their permission. These cookies may also be used for advertising purposes by these third parties. Raxwell Industrial Technology Co., Ltd. markets the product using results from the assessment. Products labeled as ECO Solutions NIOSH N95 are NOT NIOSH approved. A KN95 face mask is a type of disposable respirator. NIOSH received this product through an International Respirator Assessment request. They come in a pack of 40, are built with an adjustable nose clip, and come in colors like white, black and grey. The Moaron 2091 P100 filter is NOT a component associated with a NIOSH approval. As the .css-16acfp5{-webkit-text-decoration:underline;text-decoration:underline;text-decoration-thickness:0.125rem;text-decoration-color:#d2232e;text-underline-offset:0.25rem;color:inherit;-webkit-transition:all 0.3s ease-in-out;transition:all 0.3s ease-in-out;}.css-16acfp5:hover{color:#000;text-decoration-color:border-link-body-hover;background-color:yellow;-webkit-transition:all 0.3s ease-in-out;transition:all 0.3s ease-in-out;}Omicron variant of the Covid-19 pandemic spreads across the country, finding the right mask to protect yourself has gotten harder within previous months. (1/13/2022), Health Protective is marketing a KN95 mask as Certified KN95 respirator mask, adopted by the CDC. This statement is misleading because CDC, through NIOSH, does not approve KN95 masks. (2/18/2021), This is an example of a misrepresentation of a NIOSH Approved product. We also highlighted products based on expert guidance and in alignment with the latest from the Food and Drug Administration and the CDC we even tried every one of the masks we recommend to get a feel for them. Despite not being regulated, there are ways for these brands and their manufacturers to increase their trustworthiness, like FDA registration or inclusion in the FDAs now-defunct emergency use authorization (EUA), which it passed in 2020 to help medical workers choose KN95 masks. U-SAFE models B120 and B130 N95 particulate respirator are not NIOSH approved. Why We Like it: This KN95 mask is lightweight and comfortable, plus it comes in multiple colors. Happy Masks come in different sizes however the adjustable nose wire and ear straps help ensure a perfect fit for various face shapes. 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 statesmanufacturers, distributors, suppliers, and importers cannot use these results to make claims about their products.