If not, they're likely safe. They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. They are available in black and white, as well as multiple colors, all of which come in a pack of 10. 5-ply design: protects against airborne allergens and pollen greater than 0.3 microns in size. You should not wear international respirators with exhalation valves or vents, either, according to the CDC this guidance applies to all masks. 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 (9/9/2021), This is an example of a misrepresentation of a NIOSH approval. Check out more tips to spot counterfeit respirators. VIDA has a sustainability program to help ensure the masks get properly recycled. The Model Number/Product Line in bold text followed by (FDA) indicates these surgical N95 respirators in the table below. Additionally, Raxwell Industrial Technology Co., Ltd. is misrepresenting Raxwell model RX9501P N95 as a NIOSH Approved respirator. According to Dr. Gandhi, masks work on an individual level as long as the individual is properly wearing the face mask. As part of the federal government's quality assessment of these respirators, the FDA, working with CDC's NIOSH, conducted additional assessments and found that NIOSH's data indicated that some of the respirators authorized under the April 3, 2020 EUA did not meet the expected performance standards. Zelbuck does not have permission to use the certification mark because this is not a NIOSH Approved respirator. NIOSH does not approve KN95 products or any other respiratory protective devices certified to international standards. The website lists the SEKURA-321 as NIOSH approved with approval number TC-84A-6660. Another thing to look for: The packaging must indicate the manufacturing date. Learn more. Why We Like it: This KN95 mask is lightweight and comfortable, plus it comes in multiple colors. The counterfeit box is glossy and primarily green, and the package contains 2 stacks of 10 units. Stella Clavecillo, D.O. To confirm that the KN95 youre buying is legitimate, make sure the manufacturer is listed on the FDA's Emergency Use Authorization list. 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. Simply saying so on the box or mask is not approval. 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. 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. Why We Like it: The unique design makes the mask comfortable to wear for long periods of time (like on a flight). Masks absolutely have expiration dates. "1AQSTaqB (7/10/2020), NIOSH has not issued any letters to Foshan Flying Medical Products Co., Ltd. Alterations to this letter made it appear that Foshan Flying Medical Products was the recipient. 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. You will be subject to the destination website's privacy policy when you follow the link. The product package indicates it meets Chinese standard GB 2626-2006 and submitted to NIOSH under an International Respirator Assessment request. (10/22/2020) Experts told us that transparency regarding face masks is a must-have in any brand you shop. No certificate of approval was provided with the samples received; therefore, the authenticity of the claims cannot be validated. (9/9/2021), Moaron is NOT a NIOSH approval holder, and they are misrepresenting product as meeting NIOSH approval. (4/21/2021), EPC Product, LLC is misrepresenting product manufactured by their company as a NIOSH Approved respirator. Changshu City Hengyun Nonwoven Products Co., Ltd. is not a NIOSH approval holder or a private label assignee. Buy FDA facility approved GB2626-2006 Standard KN95 face mask, 50 units, to stay safe from dust, pollution and diseases. 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. 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. (1/4/2019). Why We Like It: These masks can be sent back to the company when youre done using them and the company will recycle them. Nor does NIOSH approve any other respiratory protective device solely certified to international standards. Models sold by EPC, including but not limited to, PT-N95F-01, PT-N95C-02, and PT-N95CS-02 are NOT NIOSH approved. 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. A KN95 mask should not be damaged in any way, Packaging should never include false claims or logos from the FDA. These cookies may also be used for advertising purposes by these third parties. You can review and change the way we collect information below. They are counterfeit, or they are no longer compliant to the NIOSH approval. 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. . To determine your areas Covid-19 Community Level, use the CDC's Covid-19 county check. As of October 15, 2020, this EUA no longer included the three eligibility criteria that were included in the previous June 6, 2020 authorization letter, meaning the FDA no longer reviewed requests to add new respirator models to Appendix A based on those criteria as of October 15, 2020. La Forte brand masks are not NIOSH approved. Our KN95 masks are FDA registered and meet Chinese standard GB2626-2006 and/or GB2626-2019 as applicable. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage: Strategies for Optimizing the Supply of N95 Respirators. Look at the markings on the front. The NIOSH website statesmanufacturers, distributors, suppliers, and importers cannot use these results to make claims about their products. List of NIOSH Approved Filtering Facepiece Respirators. Hearst Magazine Media, Inc. All Rights Reserved. NIOSH approved products satisfy the NIOSH regulatory requirements set forth in 42 C.F.R. endstream endobj 1958 0 obj <>stream Friese added that a KN95 mask generally offers more protection than double-masking anyway, as long as it fits well. From fit to comfort and everything in between, we tried KN95 masks that aligned with what medical experts and the CDC recommend looking for. Wwdoll KN95 Face Mask, Pack of 25, $28.74 (orig. Products labeled as ECO Solutions NIOSH N95 are NOT NIOSH approved. SAS allowed private labeling for this model until SAS voluntarily rescinded the NIOSH approval in 2014. A KN95 marked with a "GB" number ending in . Parents will love that the mask has a 95 percent filtration rate and can be reused up to 50 times. The counterfeit respirator uses a 3M TC number (TC 84A-0427) without 3Ms permission. 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. This counterfeit respirator, NT-V2 Nano Bi-Directional respirator, is advertised as a NIOSH approved, using a NIOSH approval number. 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. 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. Subscribe to NPPTLs listservto stay informed about changes to a respirators approval status and other relevant notifications. Health Protective advertises the KN95 mask using results from the assessment. Additionally, the TC number belongs to a 3M full facepiece respirator with cartridges. These companies cannot use this certification mark because this is not a NIOSH Approved respirator. Any misuse of these marks is at least a direct violation of applicable trademark laws. How to tell if your N95 Respirator is NIOSH Approved (2021) However, as time passed, manufacturers began to increase production of those masks, allowing the general public to purchase the most protective masks against COVID-19. N95 is a registered certification mark owned by HHS. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. (8/25/2020), This is an example of a misrepresentation of a NIOSH approval. ApePal 5-Layer Disposable KN95 Safety Face Mask at Amazon, Kimberly-Clark Professional N95 Pouch Respirator at Amazon, VIDA NIOSH and FDA Approved N95 Mask at Shopvida.com, MagiCare Medical Grade Disposable Face Masks at Amazon, ApePal 5-Layer Disposable KN95 Safety Face Mask, Kimberly-Clark Professional N95 Pouch Respirator (53358), MagiCare Medical Grade Disposable Face Masks, How Much to Expect to Pay for N95 Face Mask. Manufacturers for masks from Evolvetogether, Hope Health and Well Before are not on the list, but are only registered with the FDA. Markings required on the KN95 packaging: The name, trademark, or other means to identify the manufacturer or supplier; Type of facepiece, model, and size (if applicable); They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. The product package indicates it meets Chinese standard GB 2626-2019 and submitted to NIOSH under an International Respirator Assessment request. Experts and the CDC recommend wearing a mask that covers your mouth and nose while fitting under your chin. The CDC has provided a visual aid for NIOSH-approved N95 respirators. The masks have an adjustable nose bridge, and you can purchase as few as 10 masks, which come individually wrapped. Additionally, SAS did not give permission for the manufacturing or selling of this product. 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. However, the website is selling a counterfeit respirator and using Makrites approval number without their permission. 'C;M5erf!~s-+8M9c$POJeb/m|:jdf&HI,r|R'{71W | The N95 respirator is the most common of the seven types of particulate filtering facepiece respirators. Thank you for taking the time to confirm your preferences. To determine the best face masks for COVID-19 protection, we asked experts for their recommendations and why. At this time, NIOSH has not approved respirators that use ear loops without the use of an approved fastener. 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. Our KN95 masks are composed of a 6 ply design of meltblown and spunbond polypropylene. Cookies used to make website functionality more relevant to you. You can also purchase . (11/5/2020), This is an example of a misrepresentation of a NIOSH approval. Az yc>@b,L size . Weve kept them on the list because they meet guidance from medical experts. Standard: GB2626-2019.KN95. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. 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. Centers for Disease Control and Prevention. ####''',,, K " The mask also features headbands that go over the head versus around the ears to add more comfort for long-term wear. The masks come in six different sizes that range from XXS to XL. This respirator is not a NIOSH Approved respirator. The FDA no longer reviewed requests to add new respirator models to Exhibit 1 of this EUA after March 24, 2021. Chengde Technology Co., Ltd. is not a NIOSH approval holder or a private label assignee. However, this unit is not NIOSH approved as a filtering facepiece respirator for children. DUKAL is not a NIOSH approval holder or a private label holder. At Select, we work with experts who have specialized knowledge and authority based on relevant training and/or experience. Shapiro said KN95s should be stored in a paper bag between uses. Anshun Health and Medical Technology Co., Ltd. Meizhuangchen Health Technology (Shenzhen) Co., Ltd. Jinyi (Tianjin) Medical Technology Co., Ltd. Heyuan COE Communication Technology Co., Ltd. Guangdong Tengrui Pharmaceutical Technology Co., Ltd. AnDum Protective Equipment Technology (Changzhou) Co.,Ltd. NIOSH posts information about misrepresented and counterfeit respirators here to alert users, purchasers, and manufacturers. What experts want you to know about dog food, National Institute for Occupational Safety and Health, factors to consider when purchasing an international respirator, Covid vaccination card holders from Etsy, Amazon and more, HYPE: A Doctors Guide To Medical Myths, Exaggerated Claims and Bad Advice, The Ultimate Kids Guide To Being Super Healthy. (7/24/2020), NIOSH received notice of websites selling and misrepresenting SAS model 8617A as NIOSH approved under TC-84A-4276. Guangzhou Bofeite Safety Protective Supplies Co., Ltd. UHEALTH MEDICAL (BEIJING) PROTECTIVE PRODUCTS CO., LTD. Jingzhou Strong Sciences & Technology Development Co.,ltd. 5&eB\L"Y-QgJ#w;Toniw-z2}04jGXmbyzLk~Z-P .7OtF\gkp>Z0~IY &X'ouw1eWJW4_7n?ueHKK{L*]4,N5m>NBto++Nh nzeI4vv?^0n],P&WqBaAx;\[-)-HLkCR%3$SJM:luu>h1^ The NIOSH website states manufacturers, distributors, suppliers, and importers cannot use to make claims about their products. (3/5/2020), The Guangzhou Weini Technology & Development Co., Ltd. (GWT) respirator with model number K320 is not NIOSH approved. The Centers for Disease Control and Prevention has updated its mask guidance to fight the spread appropriately, advising against cloth masks and surgical masks alone to protect against the virus. (2/4/2021), This is an example of a misrepresentation of a NIOSH approved product. *UPDATE Shanghai Dasheng Health Products Manufacture Co., Ltd issued a user notice for select lots of the DUKALTMN95 respirator. SafeShield is not a NIOSH approval holder or private label assignee, and model FS-N95 is NOT NIOSH approved. Surgical masks can protect you from large viral droplets, but they dont filter out the smallest particles. Model TY 0424 is not NIOSH approved. 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. 1961 0 obj <>/Filter/FlateDecode/ID[<4934D10D090E404999D820306277A183>]/Index[1953 19]/Info 1952 0 R/Length 60/Prev 989616/Root 1954 0 R/Size 1972/Type/XRef/W[1 2 1]>>stream N95 is a registered certification mark owned by HHS. These models have not been NIOSH approved since 2015. 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. meets GB2626-2006 (the Chinese standard for Respiratory Protective Equipment - Non-Powered Air-Purifying Particle Respirator). We take your privacy seriously. However, please take extra precautions when purchasing to ensure you receive the authentic product and not the counterfeit version. These areexamples of counterfeit respirators and sold as if they are NIOSH approved. As of press time, the CDC is advising the general public to upgrade to N95 and KN95 masks to protect against the Omicron variant. "s "I2oa #AG |ol+\ B#)-vEon3wd)RM]qnl`0Z*OV# d7o\)bF\l|>7(='Tm`qX+Q8%Zsvgp?8xt,c\>=m{ hb```f``zAXX&ACl`PxA>Qq L[c{nZ`_ M2K<2]i@`fUU @h$l8pP]%W%W'9@h$,!aN$T[$Tqs.l 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. Shenzhen Ende Medical Technology Co., Ltd. is not a NIOSH approval holder. 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. Additionally, Good Mask Co. is misusing NIOSH test information. Saving Lives, Protecting People, The National Personal Protective Technology Laboratory (NPPTL), Factors to Consider When Planning to Purchase Respirators from Another Country, Herramientas Importadas Monterrey SA DE CV, Hong Kong Environmental Protection & Energy Saving Company, Jiangyin Chang-hung Industrial Manufacturing Factory LLC of China (JCH), Suzhou Sanical Protective Product Manufacturing Company, Ltd, Xiantao Zhongyi Safety Protection Products. Previously FDA-Approved KN95 Face Masks. Its Worth Noting: Newer masks may run larger than previous batches. 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. %PDF-1.6 % (2/19/2019). HUKsFWHHL&36S'f7,&W8KJjSu X,v_v]V}_ CYm!^a0;?5/fba~y@+eY}%xKoA; qhI$h# {#cT;/1XgoQxN,Wf;NxYt_)SfEbC43HNPJ!#9("u The NIOSH website statesmanufacturers, distributors, suppliers, and importers cannot use these results to make claims about their products. The fastener connects the loops behind the head. The product package indicates it meets Chinese standard GB 2626-2006 and submitted to NIOSH under an International Respirator Assessment request. What is a Medical-Grade Face Mask and When Do We Need to Use Them? The NIOSH stylized logo is a registered certification mark owned by HHS. SS Paper Convertors is not a NIOSH approval holder or private label holder. 5-pack: of disposable KN95 masks. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. A well-fitted N95 face mask will help reduce the transmission of the virus. Please refer to ouruser noticefor more information. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. The masks have an adjustable nose piece and their earloops are latex-free, according to the brand. The softer pouch style of this NIOSH-approved N95 mask provides a lighter and more comfortable wear than the traditional cup-shaped N95 masks, which makes it great for traveling, The design of the mask makes it easier to breathe while still forming a seal around the nose and mouth to help protect the wearer. WWDOLLs KN95 masks were also featured on the FDAs EUA list. 0e$Yp59 (12/1/2021), This is an example of a misrepresentation of a NIOSH approval. Shapiro said she wouldnt wear a KN95 more than three or four times maximum, especially if doing so for multiple hours. The wording on their website is misleading and not accurate. 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). NIOSH rescinded GWT respirator approvals in 2009. Additionally, there are two errors on the respirator package. We may earn commission from links on this page, but we only recommend products we back. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. g!c J* |D(}(a!*"x?/b*RI+!D8x:7. The KN95 masks come in multiple colors, and you can also purchase a color variety set, which comes with 15 KN95 masks. (2/18/2021), Raxwell Industrial Technology Co., Ltd. is misusing NIOSH test information regarding Raxwell model RX9501 KN95 Face Masks. Therefore, Moaron does not have permission to use this certification mark. 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. TC-84A-8125 is a valid NIOSH approval number. Intech Safety Pvt. They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements.
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