(2/18/2021), Raxwell Industrial Technology Co., Ltd. is misusing NIOSH test information regarding Raxwell model RX9501 KN95 Face Masks. The NIOSH stylized logo is a registered certification mark owned by HHS. View official letters announcing NIOSH polices, notices for users (e.g., changes in a respirators approval status), and more. The product package indicates it meets Chinese standard GB 2626-2006 and submitted to NIOSH under an International Respirator Assessment request. Finally, we bought and tried on multiple face masks and only recommended ones whose packaging, features and fit align with what experts told us to expect. endstream endobj 1958 0 obj <>stream The DemeTECH NIOSH N95 respirator face mask has been highly rated as a protective N95 mask that can be worn daily with comfort and ease. (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. ####''',,, K " Statements made alongside an image of the Arun KN95 Folding Face Mask that it is "listed on FDA EUA for Non-NIOSH Devices" and representing compliance with "GB2626-2006" [https://www . The NIOSH website states manufacturers, distributors, suppliers, and importers cannot usethese results to make claims about their products. Zhengzhou Ruipu Medical Technology Co., Ltd. advertises the product using results from the assessment. | Are KN95 masks reusable? More information is available on the Respiratory Protection Information Trusted Source. Zelbuck does not have permission to use the certification mark because this is not a NIOSH Approved respirator. KN95 masks are disposable face coverings, so you cant wash and reuse them like you can a cloth mask. 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. They are available in black and white, as well as multiple colors, all of which come in a pack of 10. Suzhou Sanical Protective Product Manufacturing Co. Ltd. manufactures Benehal Model 8865, under NIOSH approval number TC-84A-7449. These are examples of counterfeit respirators. Face masks, particularly high-filtration N95s and KN95s, were once a hot commodity during the pandemic. Zelbuck is not a NIOSH approval holder or a private label holder. All . Previously FDA-Approved KN95 Face Masks. KN95 GB2626-2006 Today we introduce our newest product, the KN95 Respirator Mask to the Chinese standard GB2626-2006. The CDCs order requiring masks on public transportation and at transportation hubs is no longer in effect, and many airlines ended their mask mandates in spring 2022. The counterfeit box is glossy and primarily green, and the package contains 2 stacks of 10 units. They come in a pack of 25 and are available in multiple colors. The product package indicates it meets Chinese standard GB 2626-2006 and submitted to NIOSH under an International Respirator Assessment request. (4/9/2020), This is an example of a counterfeit respirator. Again, the type of face mask you choose depends on several factors such as level of protection, cost, comfort, and size. meets GB2626-2006 (the Chinese standard for Respiratory Protective Equipment - Non-Powered Air-Purifying Particle Respirator). Additionally, KN95 masks will have GB2626 printed on them with 2006 or 2019 listed. #$%&'()*23456789:CDEFGHIJRUVWXYZbcdefghijrstuvwxyz !1QABS "aq Results from NIOSH's testing are provided at: https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html. Protection face mask, white, regular size (160 X 105 mm), Ear Loop KN95 face-masks filter at least 95% airborne particles that are non-oil based. We take your privacy seriously. Experts have repeatedly stressed that masks help reduce the risk of viral transmission. What is a KN95 respirator mask? Raxwell Industrial Technology Co., Ltd. markets the product using results from the assessment. Nor does the inclusion of the donning procedure or user instructions included on the website and PDF versions. Introduced in the US market in response to the Corona virus pandemic and approved for use under the CDC's EAU, the KN95 is currently being used for protection against Covid-19. Productos Qumicos y Farmacuticos R&M S.A de C.V. Mkteks Mensucat Tekstil Sanayi VE Ticaret Limited Sirketi, FFP2 NR E-300, FFP2 NR E-680, FFP2 NR 952, FFP2 NR F-820: IFU. However,. "If GB ends in 2006 its still legit if not [past the expiration date]. Enro masks feature a 99% virus, bacteria, and particle filtration efficiency rate. These respirator models had been on the list of authorized respirators in Appendix A but no longer met the EUA eligibility criteria and thus were no longer authorized. WellBefore offers KN95 masks in multiple colors and allows a choice between standard ear loops and head straps. Manufacturers for masks from Evolvetogether, Hope Health and Well Before are not on the list, but are only registered with the FDA. Now that the flu, COVID-19, and RSV are on the rise, possibly causing a tripledemic, health officials advise people to use face masks again. They also include an adjustable nose bridge and adjustable ear loops. However, the manufacturer, Zubi-Ola, is not a NIOSH approval holder or a private label holder. For additional information, please see Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities. The product listing claims the filter meets NIOSH P100-series. NIOSH only approves whole respirator configurations, not individual components. You will be subject to the destination website's privacy policy when you follow the link. Pasture Pharma did not manufacture this counterfeit respirator. ______________________________, Makrite Hubei Industrial Co., Ltd is a subsidiary of NIOSH approval holder Makrite Industries Inc. "GB2626 gives reassurance that manufacturer made mask [with] highest standard per Chinese guidelines," writes Dr. Stella in a comment. 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9480V (FFP2). The product package indicates it meets Chinese standard GB 2626-2019 and submitted to NIOSH under an International Respirator Assessment request. Buy FDA facility approved GB2626-2006 Standard KN95 face mask, 50 units, to stay safe from dust, pollution and diseases. Misrepresented respirators include all respirators that are falsely marketed and sold as NIOSH Approved respirators when they are not. Emergency Use Authorizations for Medical Devices, Recalls, Market Withdrawals and Safety Alerts, Emergency Use Authorizations for Medical Devices, Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices, Monkeypox (mpox) Emergency Use Authorizations for Medical Devices, Revoked EUAs for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators, Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China, Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment, Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities, Historical Information about Device Emergency Use Authorizations, Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China, Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs), Umbrella EUA: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China, Non-NIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China EUA FAQs, Respirator Models Previously Removed from Appendix A, Strategies for Optimizing the Supply of N95 Respirators, https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html, Umbrella EUA Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators, 9001, 9002, 9501, 9501+, 9501V+, 9502, 9502+, 9502V+, 9505+, 9541, 9541V, 9542, 9542V, 9552, 9552V, AOK Tooling Ltd. (aka Shenzhonghai Medical), 20130040, 20130045A, 20180021, 20130038, 20190019, 910, 20190029. SafeShields marketing of model FS-N95 is misleading and may cause users to believe it is NIOSH approved. Thank you for taking the time to confirm your preferences. GWT respirators bearing any NIOSH approval number listed on the user notice isnotNIOSH approved. The Model Number/Product Line in bold text followed by (FDA) indicates these surgical N95 respirators in the table below. The counterfeit respirator uses a 3M TC number (TC 84A-0427) without 3Ms permission. They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. N95 face masks are recommended by experts and the CDC for protection against COVID-19. They provide customers with a shipping label so used masks can be sent back to their facility. The Breath Buddy Particulate Filter is NOT a component associated with a NIOSH approval. NIOSH is the National Institute for Occupational Safety and Health (NIOSH) in the U.S., providing the standards for protective N95 face masks across several occupations that require them. However, the manufacturers website continues to state the ViraMask N99ESC is NIOSH certified. La Forte brand masks are not NIOSH approved. 5-pack: of disposable KN95 masks. . This is not an acceptable format for a NIOSH approved respirator. Filtering facepiece respirator has ear loops instead of headbands. G & F Products is not a NIOSH approval holder or a private label holder. 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. Medicos is selling an N95 respirator using the Moldex approval number and label without Moldexs permission. The KN95 masks come in multiple colors, and you can also purchase a color variety set, which comes with 15 KN95 masks. The logo is wrong, there is no approval number (TC-84A-xxxx). Each has six layers and an adjustable nose bridge. Masking up also protects other people, as demonstrated in numerous studies like these gathered by the CDC. Get answers to commonly asked questions about NIOSH Approved respirators and counterfeits. When purchasing face masks, its also important to consider the size, shape, and whether it has an ear loop or nose wire to help you get the most secure fit. Wwdoll KN95 Face Mask, Pack of 25, $28.74 (orig. Additionally, respirators from the box include the CE (European) approval mark and NIOSH N95. 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. (7/24/2020), NIOSH received notice of websites selling and misrepresenting SAS model 8617A as NIOSH approved under TC-84A-4276. Intech Safety Pvt. Since they sell out quickly and can be hard to come by, many people have turned to the Chinese equivalent, KN95 masks, instead. ORp?[_{?"bS?%mWZ| b_KwlxaD= 4?m`" & >O> [;o By7cM/]7v` Taylyn Washington-Harmon is a writer and editor based in Chicago. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Megha International does not have permission not use this certification mark because this is not a NIOSH Approved respirator. For all of the masks below, weve obtained associated lab tests regarding filtration. EPC Product, LLC is not a NIOSH approval holder or a private label holder. Its Worth Noting: Newer masks may run larger than previous batches. Protect yourself from dust and pollution long-time and avoid any unconfirmed or eye fogging. This is the official listing of all NIOSH Approved respirators. Moaron is not a NIOSH approval holder; P100 is a registered certification mark owned by HHS. They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. Dongguan AOXING is marketing product using results from the assessment. Respirators and replacement cartridges and filters marked as Zelbuck are NOT NIOSH approved. This product filters at least 95% of airborne particles but is not resistant to oil-based particles. The NIOSH website statesmanufacturers, distributors, suppliers, and importers cannot use these results to make claims about their products. The respirator: a) Has a registration certification, reflecting regulatory authorization, under the jurisdiction of the Chinese National Medical Products Administration (NMPA) and that is given by. 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" Surgical masks can protect you from large viral droplets, but they dont filter out the smallest particles. (12/21/2020), This is an example of a misrepresentation of a NIOSH approval. If you dont have an N95 or KN95 mask, a surgical mask is the next best option. The product package indicates it meets Chinese standard GB 2626-2006 and submitted to NIOSH under an International Respirator Assessment request. (5/26/2021), This is an example of a misrepresentation of a NIOSH approval. (12/18/2020), This is an example of a misrepresentation of a NIOSH approved product. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. hbbd``b`>$S8`9$@\F q b``$@ P Additionally, the FDA, in collaboration with CDC's NIOSH, increased surveillance and sampling of all respirators imported from China. Look at the markings on the front. (Most people use mask and respirator interchangeably, but when the CDC and medical professionals say respirator, they specifically mean specialized, fitted face coverings like N95s, KN95s and KF94s. 3M did not give Valpro Safety permission to use their approval number or label. Additionally, if you knowingly come into close contact with someone infected with Covid, or you yourself have Covid while wearing it, you should throw the mask out after a single use. High-filtration N95 masks approved by the National Institute for Occupational Safety and Health (NIOSH) are still the gold standard as they provide more robust protection (95% filtration rate against small and large particles). Summaries of FDA's reissuances of this EUA follow. 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. One 2021 CDC study found that, between two properly masked or double-masked people, the risk of one giving the other a virus was cut by over 95%. Sobmex respirators are NOT NIOSH approved. No NIOSH logo or approval number on the face of the product. Pure&Safe does not have permission to use this certification mark because this is not a NIOSH Approved respirator. NIOSH Approved FFRs will always have one of the following designations: You can verify a TC approval number is valid by checking theNIOSH Certified Equipment List. Sobmex is not a NIOSH approval holder or private label assignee.