Any misuse of these marks is at least a direct violation of applicable trademark laws. They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. 2023 SELECT | All rights reserved. Zhengzhou Ruipu Medical Technology Co., Ltd. advertises the product using results from the assessment. The CDC also has a list of NIOSH-approved. Both counterfeit and misrepresented respirators may not be capable of providing the appropriate or necessary respiratory protection to workers and users. (5/14/2020), The website, www.covidness.net, misrepresents these two examples of respirators as NIOSH approved. The masks come in three different sizes: regular, kids XS, and kids, alongside a family pack option where both kids and regular sizes can be purchased together. 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. size . 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. Pure&Safe does not have permission to use this certification mark because this is not a NIOSH Approved respirator. The strong ear loop wont break as easily as other disposable face masks. Products labeled as DermaCare or Espomega, with model numbers HY8710, HY8812, and HY8816, are NOT NIOSH approved. (2/19/2019). Evolvetogethers KN95 masks come in a pack of five and are individually wrapped in what the company has said are biodegradable pouches. 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. How to Make Sure Your N95/KN95 Mask Is Real, The 13 Best N95 Masks to Protect Against Omicron, What Makes N95 and KN95 the Gold Standard of Masks, The Difference Between a Heart Attack and a Stroke, Your Privacy Choices: Opt Out of Sale/Targeted Ads. Greater than 95% filtration efficiency: to effectively protect respiratory health. Previously FDA-Approved KN95 Face Masks. (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. Cookies used to make website functionality more relevant to you. 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. NIOSH posts information about misrepresented and counterfeit respirators here to alert users, purchasers, and manufacturers. From fit to comfort and everything in between, we tried KN95 masks that aligned with what medical experts and the CDC recommend looking for. The soft inner lining is designed for comfort and to keep your face cool and moisture free. (6/3/2020), Translation of letter: Makrite Hubei Industrial Co., Ltd has not signed any purchase contracts or agreement with any company or issued any distribution authorization. KN95 respiratory masks are masks that are regulated by the Chinese government under regulations GB2626-2006, GB262-2019, and GB19083-2010. ), SKIP AHEAD What is a KN95 mask? Cookies used to make website functionality more relevant to you. Friese added that a KN95 mask generally offers more protection than double-masking anyway, as long as it fits well. You can find a specific manufacturer by clicking on the first letter of their name on the index below. The N95 respirator is the most common of the seven types of particulate filtering facepiece respirators. KN95 GB2626-2006 Today we introduce our newest product, the KN95 Respirator Mask to the Chinese standard GB2626-2006. Proper KN95s will be given a two- to three-year expiration date, says Passas. (12/3/2020), This is an example of a misrepresentation of a NIOSH approval. These cookies may also be used for advertising purposes by these third parties. Masks absolutely have expiration dates. The TC number and private label holder are valid. FDA Revokes Emergency Use Authorizations for Non-NIOSH-Approved Disposable Respirators and Decontamination Systems as Access to FDA-authorized and NIOSH-approved N95s Increases Nationwide. To do so, it analyzes how many Covid-related hospital beds are in use, hospital admissions and the total number of new Covid cases in that area. NIOSH may pursue enforcement action. Anhui Zhongke Duling Commercial Appliance Co. Ltd. Guangdong Zhizhen Biological Medicine Co., Ltd. KN95 Three-Dimensional Protective Face Mask. Before sharing sensitive information, make sure you're on a federal government site. NIOSH entered a Memorandum of Understanding (MOU) in 2018 with the Food and Drug Administration (FDA). The counterfeit respirators use Shanghai Dasheng Health Products Manufacture Co. Ltds NIOSH approval numbers without their permission. Happy Masks come in different sizes however the adjustable nose wire and ear straps help ensure a perfect fit for various face shapes. Notice on HHS Ownership of Respirator Certification Marks. It has four protective layers, two headbands, and an adjustable nose bridge wire. N95 is a registered certification mark owned by HHS. hVQo6+|l2HJ@v,s#TI0jm$ww`4c Additionally, the FDA, in collaboration with CDC's NIOSH, increased surveillance and sampling of all respirators imported from China. We take your privacy seriously. Adobe d '$''''$25552;;;;;;;;;; They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. Our KN95 masks for sale are FDA approved and CE certified, genuine, and made following industry standards. The site is secure. Surgical N95 respirators approved under the MOU do not require FDAs 510(k) clearance. %%EOF Under this EUA, respirators, listed in Exhibit 1, were authorized for use in healthcare settings by healthcare personnel (HCP) when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the Coronavirus Disease 2019 (COVID-19) outbreak. Additionally, Good Mask Co. is misusing NIOSH test information. They are falsely indicating product can be used with half and full facepieces made by other NIOSH approval manufacturers. The counterfeit box is glossy and primarily green, and the package contains 2 stacks of 10 units. 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. Since they sell out quickly and can be hard to come by, many people have turned to the Chinese equivalent, KN95 masks, instead. Our KN95 masks are composed of a 6 ply design of meltblown and spunbond polypropylene. If you notice that a mask is wet or dirty, or if its damaged for example, if any part of it is worn away, or if the straps are broken or stretched you should throw it out, she said. To determine your areas Covid-19 Community Level, use the CDC's Covid-19 county check. See the Notes section for information about private labels. Price at time of publication: $75 Product Details: Type of. These KN95 masks were featured on the FDAs EUA list. The product package indicates it meets Chinese standard GB 2626-2006 and submitted to NIOSH under an International Respirator Assessment request. Medicos is not a NIOSH approval holder or private label holder. NIOSH approved products satisfy the NIOSH regulatory requirements set forth in 42 C.F.R. to us. All of the masks below come from manufacturers registered with the FDA while this has nothing to do with regulating mask quality, it increases accountability for the brand selling it, experts told us. Pacifico Salud SAC is selling units using Suzhou Sanical Protection (SSP) approval number (TC-84A-6766) and label without SSPs permission. Powecoms KN95 masks were featured on the FDAs EUA list. Experts we interviewed recommend you review your masks after receiving them and before wearing them with the following in mind: Additionally, Anne Miller, executive director of Project N95, a nonprofit that helps people source personal protective equipment and medical supplies, suggested shoppers review lab testing documents that clearly illustrate how well a mask acts as a filter. Since theyre designed to meet a Chinese standard, KN95s are not regulated in the U.S. From April 2020 to June 2021, the FDA had a temporary emergency use authorization that allowed U.S. health workers to use KN95s on the job. On June 30, 2021, the FDA announced the revocation of the following EUAs: As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. Sobmex respirators are NOT NIOSH approved. #$%&'()*23456789:CDEFGHIJRUVWXYZbcdefghijrstuvwxyz !1QABS "aq However, you dont have to toss a KN95 mask after a single use. (4/21/2021), EPC Product, LLC is misrepresenting product manufactured by their company as a NIOSH Approved respirator. But theyre harder to shop for heres what to know. Additionally, Moaron incorrectly advertises that it is compatible with other NIOSH approved products. Report Counterfeit or Misrepresented Respirators, Centers for Disease Control and Prevention. View official letters announcing NIOSH polices, notices for users (e.g., changes in a respirators approval status), and more. The table below includes a list of non-NIOSH-approved respirator models manufactured in China that were authorized at the time this Umbrella EUA was revoked. Suzhou Sanical Protective Product Manufacturing Co. Ltd. manufactures Benehal Model 8865, under NIOSH approval number TC-84A-7449. Model TY 0424 is not NIOSH approved. Models sold by EPC, including but not limited to, PT-N95F-01, PT-N95C-02, and PT-N95CS-02 are NOT NIOSH approved. KN95 masks are disposable face coverings, so you cant wash and reuse them like you can a cloth mask. However, please take extra precautions when purchasing to ensure you receive the authentic product and not the counterfeit version. | Are KN95 masks reusable? This disposable face mask has a three-layer protection made of soft breathable material. S TX%Z1dS8*B0 V KV>NRy+zSLHSb(}-/7-R2D SafeShields marketing of model FS-N95 is misleading and may cause users to believe it is NIOSH approved. Look at the markings on the front. The CDC said that it is most important to wear a well-fitted mask or respirator correctly that is comfortable for you and that provides good protection.. Nor does NIOSH approve any other respiratory protective device solely certified to international standards. Vogmaskis not a NIOSH approval holder. The NIOSH website statesmanufacturers, distributors, suppliers, and importers cannot use these results to make claims about their products. Its Worth Noting: These masks are on the smaller side, so they may not be a good choice for people with large faces. Pasture Pharma did not manufacture this counterfeit respirator. 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 . Nor does NIOSH approve any other respiratory protective device solely certified to international standards. The counterfeit respirator uses a 3M TC number (TC 84A-0427) without 3Ms permission. 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. #$%&'()*23456789:CDEFGHIJRTUVWXYZbcdefghijrstuvwxyz ? To register with the FDA, manufacturers pay a fee and submit certain criteria about the operation. Guangzhou Bofeite Safety Protective Supplies Co., Ltd. UHEALTH MEDICAL (BEIJING) PROTECTIVE PRODUCTS CO., LTD. Jingzhou Strong Sciences & Technology Development Co.,ltd. If you click on links we provide, we may receive compensation. G & F Products is not a NIOSH approval holder or a private label holder. KN95 masks are manufactured to offer 95% protection from particulate matter, like the N95 mask. 100% Cotton Elastic Earloop closure PREMIUM QUALITY: Our Unisex KN95 face masks provide you with a high-quality elastic widening ear loop to ensure a comfortable wearing experience and adjustable nose clip. 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. ~p.`QFFX%A._}Ba) .k[xx1qIbs6e)IOd#L) NDdUd}1|" Surgical N95 respirators approved under the MOU do not require FDA's 510 (k) clearance. U-SAFE is not a NIOSH approval holder or a private label assignee. The product listing claims the filter meets NIOSH P100-series. NIOSH only approves whole respirator configurations, not individual components. Any manufacturer names present on the respirator, NIOSH approval number (e.g., TC 84A-XXXX), if present, Web url where respirator was purchased or found. Intech Safety Pvt. With all the different masks to choose from, many factors come into play when choosing a mask, such as when to wear one, the level of protection you want, fit, comfort, and cost-effectiveness. These respirators were authorized for use by healthcare personnel in healthcare settings in accordance with the CDC's recommendations. These links do not constitute an endorsement of their content, or a statement of NIOSH policy. Counterfeit respirators specifically refer to products trying to copy an actual NIOSH Approved model. N95 face masks are recommended by experts and the CDC for protection against COVID-19. As the federal entity responsible for the Respirator Approval Program, NIOSH is the custodian of these certification marks. Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V. endstream endobj 1958 0 obj <>stream Medical-grade face masks are loose-fitting, disposable masks that create a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. To recommend when Americans should wear face masks, the CDC determines an areas Covid-19 Community Level risk on a scale of low, medium or high. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Protect yourself from dust and pollution long-time and avoid any unconfirmed or eye fogging. This counterfeit respirator uses NIOSH approval holder Shining Star Electronic Technologys NIOSH approval number (TC-84A-8125, model SS6001-N95) without their permission. The counterfeit respirator uses Shanghai Dasheng Health Products Manufacture Co. Ltds NIOSH approval number, TC 84A-4335, without their permission. For more information, view the NIOSH Conformity Assessment Letter to Manufacturers, NIOSH CA 2022-1041R1. La Forte brand masks are not NIOSH approved. 3M did not give Valpro Safety permission to use their approval number or label. The ultra-lightweight mask also provides comfort that helps wearers breathe easier, even while running and exercising. The NIOSH website statesmanufacturers, distributors, suppliers, and importers cannot use these results to make claims about their products. "If GB ends in 2006 its still legit if not [past the expiration date]. 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9480V (FFP2). Why We Like it: It filters out more than 98 percent of airborne particles and is made in the United States. This is anexample of misrepresentation of the NIOSH approval. The product package indicates it meets Chinese standard GB 2626-2006 and submitted to NIOSH under an International Respirator Assessment request. If you suspect you have a counterfeit or misrepresented respirator, contact NIOSH at ppeconcerns@cdc.gov. PitBull Safety Products is not a NIOSH approval holder nor are they a NIOSH private label holder. Its Worth Noting: This mask may not be a great option for people with small faces. SOUND is not a NIOSH approval holder or a private label holder. KN95 Protective Face Mask GB2626 Standard (10-Pack) Protect yourself from airborne dust, pollen Protect yourself from airborne dust, pollen and other allergens with the KN95 Protective Face Mask from SUPPLYAID. NIOSH rescinded all approvals for Wein Products (WPI) in 2011. A banged up or partially opened box is an obvious sign of damage or tampering. With a 95 percent filtration rate, N95 masks reduce the wearer's exposure to particles including small particle aerosols and large droplets. Stella Clavecillo, D.O. The product package indicates it meets Chinese standard GB 2626-2019 and submitted to NIOSH under an International Respirator Assessment request. They provide customers with a shipping label so used masks can be sent back to their facility. The 5-ply foldable KN95 mask has over 95% filtration . Guangzhou Nan Qi Xing Non-Woven Co., Ltd. Huizhou Green Communication Equipment Manufacturing Co., Ltd. Jinhua Jiadaifu Medical Supplies Co., Ltd. Zhengzhou Ruipu Medical Technology Co. Ltd, Zhongkang Protective Equipment Technology (Guangzhou) Co., Ltd. Jiangsu Jiaao Medical Technology Co., Ltd. Liaoning Dalian Jieying Energy Saving Environmental Protection Technology Development Co., Ltd. Hunan Kangweining Medical Devices Co., Ltd. Chongqing China Nano Technology Co., Ltd. JIANGSU HOMCAN MEDICAL TECHNOLOGY CO. LTD, ZIGONG WEIKANG MEDICAL EQUIPMENT CO., LTD, Guangdong GangRong Medical Technology Co., Ltd. Guangdong Winsun Personal Care Products Co., Ltd. Guangzhou Carrot Mall Network Technologies Co., Ltd. Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd, Donghua Siecom Communication Technology Co.,Ltd, ZHEJIANG SHUNFA SAFETY TECHNOLOGY CO., LTD. JiangSu EverSmart Nano Technology Co., Ltd. Guangdong Seyouse Technology and Culture CO,.LTD. Learn more about signs that a mask is a counterfeit through CDC resources here. For example, Miller says the front of KN95s are supposed to be stamped with both the company name and the respirator standard number. Find NIOSH Approved particulate filtering facepiece respirators and their donning instructions. (12/3/2020), This is an example of a misrepresentation of a NIOSH approval. 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. . (11/5/2021), Dongguan AOXING is misusing NIOSH test information for its KN95 Protective Mask model AX-KF95. 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). The mask must be snug on your face while allowing you to breathe easily. Read honest and unbiased product reviews from . Its Worth Noting: Sizes may run larger than the measurements indicated on the website. (11/6/2019), This product is not NIOSH approved. The KN95 masks come in multiple colors, and you can also purchase a color variety set, which comes with 15 KN95 masks. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. This web page provides a table of NIOSH-approved N95 respirators listed by manufacturer from A-Z. 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. 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. 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. 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