For example, Miller says the front of KN95s are supposed to be stamped with both the company name and the respirator standard number. They are falsely indicating product can be used with half and full facepieces made by other NIOSH approval manufacturers. (11/6/2019), NIOSH does not approve any type of respiratory protection for kids. EPC Product, LLC is not a NIOSH approval holder or a private label holder. Shapiro said she wouldnt wear a KN95 more than three or four times maximum, especially if doing so for multiple hours. 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. If so, it will void the NIOSH approval. The counterfeit respirator uses Shanghai Dasheng Health Products Manufacture Co. Ltds NIOSH approval number, TC 84A-4335, without their permission. If youre wondering which type of face covering to choose, respirators among them KN95 masks and N95 masks offer more protection than cloth masks, according to the CDC, which stops short of directly recommending one mask over another. Proper KN95s will be given a two- to three-year expiration date, says Passas. TC-84A-8125 is a valid NIOSH approval number. These masks also feature an adjustable nose bridge. Models sold by EPC, including but not limited to, PT-N95F-01, PT-N95C-02, and PT-N95CS-02 are NOT NIOSH approved. Historical information regarding these EUAs can be found on Historical Information about Device Emergency Use Authorizations. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 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. With a 95 percent filtration rate, N95 masks reduce the wearer's exposure to particles including small particle aerosols and large droplets. From fit to comfort and everything in between, we tried KN95 masks that aligned with what medical experts and the CDC recommend looking for. Masking up also protects other people, as demonstrated in numerous studies like these gathered by the CDC. (11/6/2019), This product is not NIOSH approved. 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. We took the experts' recommendations into consideration alongside the recommendations of the CDC when picking each face mask listed. How to know if an N95 or KN95 face mask is real to prevent COVID Select readers can get 20% off Evolvetogether's masks now through Mar. On May 1, 2020, the FDA issued an umbrella EUA for emergency use of protective barrier enclosures by HCP when caring for or performing medical procedures on patients who are known or suspected to. NIOSH entered a Memorandum of Understanding (MOU) in 2018 with the Food and Drug Administration (FDA). On April 3, 2020, the FDA issued an umbrella EUA for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the National Institute for Occupational Safety and Health (NIOSH). (2/10/2020), There are no markings on the face of the respirator. At Select, we work with experts who have specialized knowledge and authority based on relevant training and/or experience. 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. endstream endobj 1958 0 obj <>stream According to the CDC, as many as 60 percent of KN95 masks available could be fakes. efH3~#mM3IrNeYvbPF?$8}'|Oqq6_@Of|\CJq%Zq1. Shining Star Electronic Technology Co., Ltd. Shanghai Gangkai Purifying Products Company, Ltd. MSA do Brasil Equipamentos e Instrumentos de Seguranca Ltd.a. The counterfeit respirators use Shanghai Dasheng Health Products Manufacture Co. Ltds NIOSH approval numbers without their permission. Nor are they a private label holder. 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. Happy Masks are a hit with children because they come in a variety of colors and designs. If you dont have an N95 or KN95 mask, a surgical mask is the next best option. Counterfeit Respirators | NPPTL | NIOSH | CDC ####''',,, Products labeled as ECO Solutions NIOSH N95 are NOT NIOSH approved. NIOSH posts information about misrepresented and counterfeit respirators here to alert users, purchasers, and manufacturers. 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. (12/17/2021), This is an example of a misrepresentation of NIOSH approval. The product package indicates it meets Chinese standard GB 2626-2006 and submitted to NIOSH under an International Respirator Assessment request. Yark is not a NIOSH approval holder or a private label holder. However, the website is selling a counterfeit respirator and using Makrites approval number without their permission. The wording on their website is misleading and not accurate. Vogmaskis not a NIOSH approval holder. On June 30, 2021, the US Food and Drug Administration (FDA) announced the revocation of the Emergency Use Authorizations (EUAs) for non-NIOSH approved respirators from China and other countries outside the US due to multiple factors including the increase in availability of NIOSH approved respirators. 17 with code SELECT20. A KN95 mask can be worn multiple times If you remove and store it properly. They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. 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. They are counterfeit, or they are no longer compliant to the NIOSH approval. In case of any business or individual claiming to have the authorization letter or certification from Makrite Hubei Industrial Co., Ltd, please report to the police immediately. However, this unit is not NIOSH approved as a filtering facepiece respirator for children. The U.S. Department of Health and Human Services (HHS) is the owner of these certification marks. NIOSH rescinded GWT respirator approvals in 2009. Zhengzhou Ruipu Medical Technology Co., Ltd. is not a NIOSH approval holder or a private label holder. KN95 protective mask GB2626-2006 - Silverfox Corporation Limited - PDF "If GB ends in 2006 its still legit if not [past the expiration date]. Surgical N95 respirators approved under the MOU do not require FDAs 510(k) clearance. These markings indicate a quality. KN95 is a performance rating under the Chinese standard GB2626:2006, the requirements of which are broadly the same as the European standard BSEN149:2001+A1:2009 for FFP2 facemasks. NIOSH received this product through an International Respirator Assessment request. GUANGDONG GOLDEN LEAVES TECHNOLOGY DEVELOPMENT CO., LTD. Only manufacturers who are NIOSH approval holders may use these registered certification marks in accordance with applicable laws. . For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage: Strategies for Optimizing the Supply of N95 Respirators. (8/7/2020), This is an example of a misrepresentation of a NIOSH approval. Check if all the masks are identical and there aren't any mix-ups. Previously FDA-Approved KN95 Face Masks. Each mask features five layers for ample protection. 'C;M5erf!~s-+8M9c$POJeb/m|:jdf&HI,r|R'{71W | 1. Coronavirus is even smaller, at 0.1 microns, but are typically bound to something larger (like droplets), so it's purported to be 95 percent protective.". (1/4/2019). Price at time of publication: $75 Product Details: Type of. The KN95 mask could be an effective method of protection against airborne pathogens. ORp?[_{?"bS?%mWZ| b_KwlxaD= 4?m`" & >O> [;o By7cM/]7v` However,. When it comes to . Anyone claiming that they have authorization or a purchase contract with Makrite Hubei Industrial Co., Ltd is forgery and infringement. Buy FDA facility approved GB2626-2006 Standard KN95 face mask, 50 units, to stay safe from dust, pollution and diseases. However, please take extra precautions when purchasing to ensure you receive the authentic product and not the counterfeit version. Medicos is not a NIOSH approval holder or private label holder. 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). 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. 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. This disposable face mask has a three-layer protection made of soft breathable material. These companies cannot use this certification mark because this is not a NIOSH Approved respirator. You can also purchase . 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. (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. Chengde Technology Co., Ltd. is not a NIOSH approval holder or a private label assignee. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. NIOSH does not approve filtering facepiece respirators for children. Notice on HHS Ownership of Respirator Certification Marks. 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. They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. The CDC recommends making sure it completely covers your mouth and nose and fits tightly against your face to prevent gaps around the sides of the mask, nose and chin. (1/11/2022), Guangzhou Zhen Tao Culture Media Co., Ltd. is marketing Benehal Model 8865 as a NIOSH Approved respirator for kids. Powecoms KN95 masks were featured on the FDAs EUA list. To register with the FDA, manufacturers pay a fee and submit certain criteria about the operation. (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. Before sharing sensitive information, make sure you're on a federal government site. The 5-ply foldable KN95 mask has over 95% filtration . g1>Es}( 4 Pz:GH 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. The maximum and minimum filter efficiency was 99.00% and 98.31%, respectively. In response, the FDA revised and reissued the EUA on May 7, 2020, including revising the third eligibility criterion such that all respirators that were previously authorized only under that criterion were no longer within the scope of authorization and were accordingly removed from Appendix A unless the respirator model was authorized under one of the remaining eligibility criterion in the May 7th letter.