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. This is no longer a valid NIOSH approval number. The Breath Buddy Particulate Filter is NOT a component associated with a NIOSH approval. To learn more about how to identify a NIOSH Approved FFR, check out the fact sheet and graphic below. N95 is a registered certification mark owned by HHS. 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. Shapiro said she wouldnt wear a KN95 more than three or four times maximum, especially if doing so for multiple hours. It later ended the EUA because NIOSH-approved respirators were no longer in short supply. Additionally, Moaron incorrectly advertises that it is compatible with other NIOSH approved products. Enro masks feature a 99% virus, bacteria, and particle filtration efficiency rate. So if you see the phrases FDA-approved or NIOSH-approved on the packaging of KN95 masks, its a red flag. The fastener connects the loops behind the head. Osprey is not a NIOSH approval holder or a private label assignee. And people at higher risk of getting sick (such as the elderly, people with certain medical conditions, or pregnant individuals) should consider wearing masks regardless of the level of COVID in their community. This list is reviewed and updated weekly. To determine the best face masks for COVID-19 protection, we asked experts for their recommendations and why. The Pure&Safe 5 Layered Reusable Anti-Pollution N95 Face Mask with Activated Carbon Filter is not NIOSH approved. (10/22/2020) . 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. For more information, view, Private label of Foss Manufacturing Company. ZHEJIANG LUYAO ELECTRONICS TECHNOLOGY CO., LTD. Chongqing Zisun (Zaisheng) Technology Corp., Ltd. Shandong Haidike Medical Products Co., Ltd. 1971 0 obj <>stream Part 84. CORRECTION (Aug. 26, 2021, 5:45 p.m.): A previous version of this article incorrectly included some face mask manufacturers on the FDAs EUA list. 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. 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. . %%EOF Shining Star Electronic Technology Co., Ltd. Shanghai Gangkai Purifying Products Company, Ltd. MSA do Brasil Equipamentos e Instrumentos de Seguranca Ltd.a. (10/23/2019), This is anexample of misrepresentation of the NIOSH-approval. NIOSH entered a Memorandum of Understanding (MOU) in 2018 with the Food and Drug Administration (FDA). The logo is wrong, there is no approval number (TC-84A-xxxx). On October 15, 2020, the FDA reissued the EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators manufactured in China to authorize for emergency use only those respirators listed in the EUA's Appendix A as of the date of this reissuance. (2/4/2021), 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. ZK-BEST (Xiamen) Environmental Science & Technology Co., Ltd. Hunan EEXI Technology & Service Co., Ltd. Suzhou Dongshan Precision Manufacturing Co., Ltd., Carte Medical Equipment (Suzhou) Co., Ltd. Dongguan Pan American Electronics Co., Ltd. Fujian Dahong Industrial Development Co. Ltd. Hangzhou San Qiang Safety Protection Products Co., Ltd. 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3), Anshun Health and Medical Technology Co., LTD, Bei (Dong Shan) Protective Supplies Co., LTD, Changsha JNEYL Medical Equipment Co., Ltd, Changzhou Wedream Medical Device Co., Ltd, DongGuan HuaGang Communication Technology Co., Ltd, Dongguan Xianda Medical Equipment Co., Ltd, Foshan Nanhai Weijian Sanbang Protective Equipment Technology Co., Ltd, Guangdong Kaper Protection Technology Co., Ltd, Earhook folding type K1-K100, Headband folding type K1-K100, Guangzhou Yihere Medical Technology Development Co., Ltd, PPDS Disposable Protective Respirator Strap Headband, PPDS Disposable Protective Respirator Ear Hook. Disclaimer: The links in this section go to websites outside of CDC/NIOSH. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Sobmex does not have permission to use this certification mark because this is not a NIOSH Approved respirator. For an optimal experience visit our site on another browser. The table below includes a list of non-NIOSH-approved disposable FFRs that were authorized under this Umbrella EUA for emergency use in healthcare settings by HCP when used in accordance with CDC recommendations. 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. Masks produced after July 1, 2021, bear the standard number. On June 30, 2021, the FDA announced the revocation of EUA (effective July 6, 2021). Fits securely over face: to prevent shifting during movement. HUKsFWHHL&36S'f7,&W8KJjSu X,v_v]V}_ CYm!^a0;?5/fba~y@+eY}%xKoA; qhI$h# {#cT;/1XgoQxN,Wf;NxYt_)SfEbC43HNPJ!#9("u (12/3/2020), This is an example of a misrepresentation of a NIOSH approval. EPC Product, LLC is not a NIOSH approval holder or a private label holder. Products labeled as DermaCare or Espomega, with model numbers HY8710, HY8812, and HY8816, are NOT NIOSH approved. (7/24/2020), NIOSH received notice of websites selling and misrepresenting SAS model 8617A as NIOSH approved under TC-84A-4276. Evolvetogethers KN95 masks come in a pack of five and are individually wrapped in what the company has said are biodegradable pouches. 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. N95 and NIOSH Approved are certification marks of the U.S. Department of Health and Human Services (HHS) registered in the United States and several international jurisdictions. With its wide elastic ear loops and five-layer protection, this mask provides a comfortable fit that allows you to breathe easily during prolonged wear. Look for the KN95 standard printed on the mask In 2020, the FDA granted emergency-use authorization (EUA) for some KN95 masks due to N95 masks supply being scarce. Check if the manufacturer is listed here. 1*2={Z:4l#H2 b 0@>?Cz9Xsie^ At Select, we work with experts who have specialized knowledge and authority based on relevant training and/or experience. This disposable face mask has a three-layer protection made of soft breathable material. This is anexample of misrepresentation of the NIOSH approval. Any misuse of these marks is at least a direct violation of applicable trademark laws. The masks have an adjustable nose bridge, and you can purchase as few as 10 masks, which come individually wrapped. 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. ______________________________, Makrite Hubei Industrial Co., Ltd is a subsidiary of NIOSH approval holder Makrite Industries Inc. Chengde Technology Co., Ltd. is not a NIOSH approval holder or a private label assignee. 1953 0 obj <> endobj 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 product listing claims the filter meets NIOSH P100-series. NIOSH only approves whole respirator configurations, not individual components. These NIOSH-approved surgical N95 respirators are only on the Certified Equipment List (CEL). Medicos is not a NIOSH approval holder or private label holder. Sobmex is not a NIOSH approval holder or private label assignee. (11/5/2021), Dongguan AOXING is misusing NIOSH test information for its KN95 Protective Mask model AX-KF95. Powecom KN95 Respirator Masks , model GB2626-AA, are FDA approved non-NIOSH KN95 face piece respirators that protect against airborne bacteria, germs, viruses, and other particulates that are 0.3 microns or larger in size that have been authorized for use by medical professionals as per the May 7th, 2020 Appendix A update. SOUND is not a NIOSH approval holder or a private label holder. 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. La Forte brand masks are not NIOSH approved. Taylyn Washington-Harmon is a writer and editor based in Chicago. (11/5/2020), This is an example of a misrepresentation of a NIOSH approval. The counterfeit box is glossy and primarily green, and the package contains 2 stacks of 10 units. "1AQSTaqB GWT respirators bearing any NIOSH approval number listed on the user notice isnotNIOSH approved. They also include an adjustable nose bridge and adjustable ear loops. List of NIOSH Approved Filtering Facepiece Respirators. Zelbuck does not have permission to use the certification mark because this is not a NIOSH Approved respirator. The N95 respirator is the most common of the seven types of particulate filtering facepiece respirators. Find NIOSH Approved particulate filtering facepiece respirators and their donning instructions. 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 . But theyre harder to shop for heres what to know. We take your privacy seriously. The agency said disposable surgical masks and reusable cloth masks offer less protection. Powecoms KN95 masks were featured on the FDAs EUA list. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The maximum and minimum filter efficiency was 99.00% and 98.31%, respectively. Health Protective advertises the KN95 mask using results from the assessment. Surgical N95 respirators approved under the MOU do not require FDAs 510(k) clearance. 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. If not, they're likely safe. SafeShield references certification to NIOSH CFR 42.84 180-181 and TEB-APR-STP-0059. Thank you for taking the time to confirm your preferences. Keep in mind face masks come in all different shapes and sizes. Our KN95 masks for sale are FDA approved and CE certified, genuine, and made following industry standards. (2/18/2021), This is an example of a misrepresentation of a NIOSH Approved product. Breath Buddy is NOT a NIOSH approval holder. Additionally, an abbreviated approval label is on the filtering facepiece respirator (FFR) itself or straps. Real KN95s will be stamped with either "GB 2626-2006" or "GB 2626-2019," indicating that they were approved through either the older (2006) or newer (2019) standards in China. However, please take extra precautions when purchasing to ensure you receive the authentic product and not the counterfeit version. Proper KN95s will be given a two- to three-year expiration date, says Passas. 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. 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. Additionally, respirators from the box include the CE (European) approval mark and NIOSH N95. These cookies may also be used for advertising purposes by these third parties. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage: Strategies for Optimizing the Supply of N95 Respirators. (1/26/2022), Chengde Technology Co., Ltd. is misusing NIOSH test information regarding Gosbuy KN95 face masks. 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. The ear loop of this mask is made of a highly stretchable soft material that is latex-free. 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. Intech Safety Pvt. Suzhou Sanical Protective Product Manufacturing Co. Ltd. manufactures Benehal Model 8865, under NIOSH approval number TC-84A-7449. Surgical N95 respirators approved under the MOU do not require FDA's 510 (k) clearance. Filtering facepiece respirator has ear loops instead of headbands. We offer a range of different types of face masks that fit various budgets and various levels of protection. With its unique parrot-beak design, the mask leaves space for your nose and mouth to easily breathe while still protecting you with its five layers of protection. If so, it will void the NIOSH approval. They are falsely indicating product can be used with half and full facepieces made by other NIOSH approval manufacturers. We may earn commission from links on this page, but we only recommend products we back. Each mask features five layers for ample protection. The NIOSH stylized logo is a registered certification mark owned by HHS. Get answers to commonly asked questions about NIOSH Approved respirators and counterfeits. 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. 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. Additionally, Health Protective is misusing NIOSH test information. Greater than 95% filtration efficiency: to effectively protect respiratory health. ! 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. Changshu City Hengyun Nonwoven Products Co., Ltd. is not a NIOSH approval holder or a private label assignee. However, note the misspelling of NIOSH on the front of the respirator. Standard: GB2626-2019.KN95. Neither Pangolin nor Pangocare is a NIOSH approval holder or a private label holder. The NIOSH website statesmanufacturers, distributors, suppliers, and importers cannot use these results to make claims about their products. (9/9/2021), Moaron is NOT a NIOSH approval holder, and they are misrepresenting product as meeting NIOSH approval. ####''',,, Powecom's KN95 masks were featured on the FDA's EUA list. UPDATE (Aug. 26, 2021, 5:45 p.m.): A previous version of this article included the VIDA KN95 face mask. Its Worth Noting: The masks are not individually wrapped, so they may be hard to carry as spares when out and about. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Masking up also protects other people, as demonstrated in numerous studies like these gathered by the CDC. Pacifico Salud SAC is selling units using Suzhou Sanical Protection (SSP) approval number (TC-84A-6766) and label without SSPs permission. (8/25/20), This is an example of a misrepresentation of a NIOSH Approved product. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. KN95 respiratory masks are masks that are regulated by the Chinese government under regulations GB2626-2006, GB262-2019, and GB19083-2010. However, you dont have to toss a KN95 mask after a single use. 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. These respirators were authorized for use by healthcare personnel in healthcare settings in accordance with the CDC's recommendations. This is especially relevant for KN95 masks, which arent regulated the way N95 masks are. Please refer to ouruser noticefor more information. FDA Advisory No. #$%&'()*23456789:CDEFGHIJRTUVWXYZbcdefghijrstuvwxyz ? The .gov means its official.Federal government websites often end in .gov or .mil. (4/9/2020), This is an example of a counterfeit respirator. SAS allowed private labeling for this model until SAS voluntarily rescinded the NIOSH approval in 2014. Xiantao Fushi Protective Products Co., Ltd. is not a NIOSH approval holder or a private label holder. When comparing different types of masks, properly fitted respirators provide the highest level of protection, including N95s and KN95s, according to the CDC. When you visit the site, Dotdash Meredith and its partners may store or retrieve information on your browser, mostly in the form of cookies. SafeShields marketing of model FS-N95 is misleading and may cause users to believe it is NIOSH approved. Regardless of the type of mask you wear, it wont protect you or the people around you unless you wear it correctly. Therefore, Moaron does not have permission to use this certification mark. The masks come in six different sizes that range from XXS to XL. 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. The FDA does not permit their logo to appear on packaging of any sort, KN95 masks shouldnt cost more than $3 apiece, according to the CDC. (2/18/2021), Chengde Technology Co., Ltd. is misusing NIOSH test information regarding WWDOLL model CD9501B KN95 Foldable Protective Masks. 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. 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. Nor are they a private label holder. Learn more about how to identify NIOSH Approved respirators and counterfeits. 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). Before sharing sensitive information, make sure you're on a federal government site. 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). Any N95 filtering facepiece respirators from Shenzhen Ende claiming NIOSH approval or accompanied by these documents arenot NIOSH approved.(4/27/2020). 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. The product package indicates it meets Chinese standard GB 2626-2006 and submitted to NIOSH under an International Respirator Assessment request. 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. 'p^c8EN%VR[44g EtglF 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. 0e$Yp59 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. Megha International does not have permission not use this certification mark because this is not a NIOSH Approved respirator. Pangolin and Pangocare do not have permission to use this mark because this is not a NIOSH Approved respirator. ####''',,, K " Guangdong Languan Medical Biotechnology Co., Ltd. Zhejiang Dongmeng Medical Equipment Co., LTD, Changshu Dayi Health Protection Articles Co., Ltd, FOSHAN FLOCON MEDICAL EQUIPMENTS CO., LTD, QUANZHOU LIGAO PROTECTIVE PRODUCT MANUFACTURER CO.,LTD, Zhuhai HealthPro Medical Equipment Co., Ltd. Fujian Yifa Healthcare Products Co., Ltd. Dongguan Rysam Medical Equipment Manufacturing Co. Price at time of publication: $75 Product Details: Type of. As we mentioned above, KN95 masks are designed to meet a Chinese standard and theyre not regulated in the U.S. However, the website is selling a counterfeit respirator and using Makrites approval number without their permission. 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. On March 24, 2020, the FDA issued an umbrella EUA for certain imported disposable filtering facepiece respirators (FFRs) that are not approved by the National Institute for Occupational Safety. The outer layers are made with a non-woven material that is soft against the skin, while the three inner layers are made from hot air cotton and melt-blown fabric. Although they appear to be from NIOSH, these documents include alterations and false information. This product filters at least 95% of airborne particles but is not resistant to oil-based particles. Why We Like It: These masks can be sent back to the company when youre done using them and the company will recycle them. 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. Learn more. No certificate of approval was provided with the samples received; therefore, the authenticity of the claims cannot be validated. (1/11/2022), Guangzhou Zhen Tao Culture Media Co., Ltd. is marketing Benehal Model 8865 as a NIOSH Approved respirator for kids. To confirm that the KN95 you're buying is legitimate, make sure the manufacturer is listed on the FDA's Emergency Use Authorization list. The mask also features headbands that go over the head versus around the ears to add more comfort for long-term wear. Dongguan AOXING is not a NIOSH approval holder or a private label assignee. E\^ CO1_`b UjFDVB^uO|cYSNG["@&V21kS|g|m)]1o=HgB$+6_eYkPf]. The mask features double-welded head straps with an adjustable nose piece to provide a strong fit and seal against the wearer's face. Read honest and unbiased product reviews from . Subscribe to NPPTLs listservto stay informed about changes to a respirators approval status and other relevant notifications. Pangocare models MSKP4001 and MSKP4002 are not NIOSH approved. 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. Additionally, the TC number belongs to a 3M full facepiece respirator with cartridges. hey cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. An official website of the United States government, : Additionally, the FDA, in collaboration with CDC's NIOSH, increased surveillance and sampling of all respirators imported from China.