Learn more about how to identify NIOSH Approved respirators and counterfeits. Medicos is selling an N95 respirator using the Moldex approval number and label without Moldexs permission. Historical information regarding these EUAs can be found on Historical Information about Device Emergency Use Authorizations. We take your privacy seriously. Catch up on Select's in-depth coverage of personal finance, tech and tools, wellness and more, and follow us on Facebook, Instagram and Twitter to stay up to date. Each Covid-19 Community Level corresponds to a masking recommendation suggested precautions increase alongside the level. (11/6/2019), Images here are examples of counterfeit respirators and sold as if they are NIOSH approved. La Forte brand masks are not NIOSH approved. Our best overall mask DemeTECH NIOSH N95 Respirator Face Mask comes in a pack of 20 for $65, while our budget choice Boncare KN95 Face Mask costs $13 for a pack of 30. 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. They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. Why We Like it: These fun, colorful masks feature a unique parrot design that makes them comfortable for kids to wear. FitSeal, is not a NIOSH approval holder or a private label holder. 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. From fit to comfort and everything in between, we tried KN95 masks that aligned with what medical experts and the CDC recommend looking for. (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. 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. The foldable mask features a triangular design that fits snugly on the face but still leaves plenty of breathing room around the nose and mouth. 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. Parents will love that the mask has a 95 percent filtration rate and can be reused up to 50 times. (1/4/2019). We independently evaluate all recommended products and services. Many shoppers have noted how well the mask can be molded to properly fit their faces. Farah Khan, MD, is an allergist/immunologist that treats pediatric and adult patients in her private practice in Northern Virginia. As of press time, the CDC is advising the general public to upgrade to N95 and KN95 masks to protect against the Omicron variant. 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. Don't use a mask with damaged packaging for your own safety. However, please take extra precautions when purchasing to ensure you receive the authentic product and not the counterfeit version. Powecoms KN95 masks were featured on the FDAs EUA list. Any misuse of these marks is at least a direct violation of applicable trademark laws. Masks are disposable and cannot be washed or reused. They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. Buy FDA facility approved GB2626-2006 Standard KN95 face mask, 50 units, to stay safe from dust, pollution and diseases. Its Worth Noting: Newer masks may run larger than previous batches. 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. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 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. 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. 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. 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. Disclaimer: The links in this section go to websites outside of CDC/NIOSH. (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. (8/7/2020), This is an example of a misrepresentation of a NIOSH approval. Protect yourself from dust and pollution long-time and avoid any unconfirmed or eye fogging. The NIOSH website states manufacturers, distributors, suppliers, and importers cannot use to make claims about their products. (12/17/2021), This is an example of a misrepresentation of NIOSH approval. hbbd``b`>$S8`9$@\F q b``$@ P 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. The Breath Buddy Particulate Filter is NOT a component associated with a NIOSH approval. 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. This model has not been NIOSH approved since 2017. If you click on links we provide, we may receive compensation. Users cannot use this filter in place of the filter component associated with the NIOSH Approved respiratory protective device. Each has six layers and an adjustable nose bridge. The ear loop of this mask is made of a highly stretchable soft material that is latex-free. Additionally, Moaron incorrectly advertises that it is compatible with other NIOSH approved products. 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. The company references NPPTL testing claims , using an image of the test setup from the assessment. Huizhou Yibaidu Medical Device Technology Co., Ltd. XIAMEN LIANYI INDUDSTIRAL & TRADING CO., LTD. Qingdao Bioforce-aid Technology Co., Ltd. Xiamen Chengchuang Automotive Materials Co., Ltd. Foshan Nanhai Chuanzhishang Clothing Co., LTD. Hangzhou Gang Yu Health Products Co., Ltd. Jiangsu Kangershun Protective Equipment Co., Ltd. ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD. 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. Part 84. 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. (5/15/2020), This is an example of a misrepresentation of a NIOSH approved product. 9.":NBG1`L,i!P(7\,Dbe b@;hh 2;rH(W0B4GdJR'+]6 G 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%. For more information, view the NIOSH Conformity Assessment Letter to Manufacturers, NIOSH CA 2022-1041R1. The product package indicates it meets Chinese standard GB 2626-2006 and submitted to NIOSH under an International Respirator Assessment request. The N95 respirator is the most common of the seven types of particulate filtering facepiece respirators. (4/9/2020), Any respirators sold as Maskin are no longer NIOSH approved. Megha International does not have permission not use this certification mark because this is not a NIOSH Approved respirator. 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. We take your privacy seriously. Pangolin and Pangocare do not have permission to use this mark because this is not a NIOSH Approved respirator. Chengde Technology Co., Ltd. markets the product using results from the assessment. NIOSH approved products satisfy the NIOSH regulatory requirements set forth in 42 C.F.R. The product package indicates it meets Chinese standard GB 2626-2006 and submitted to NIOSH under an International Respirator Assessment request. Megha International is marketing the Feel Safe Mask N95 in a package marked NIOSH Certification. "1AQSTaqB EPC Product, LLC is not a NIOSH approval holder or a private label holder. Additionally, Good Mask Co. is misusing NIOSH test information. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Filtering facepiece respirator has ear loops instead of headbands. A KN95 marked with a "GB" number ending in . Yamada brand masks, including models 5241 and 8242, are not NIOSH approved. However, this unit is not NIOSH approved as a filtering facepiece respirator for children. 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. 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); Happy Masks are a hit with children because they come in a variety of colors and designs. Users cannot use this filter in place of the filter component associated with the NIOSH Approved respiratory protective device. You will be subject to the destination website's privacy policy when you follow the link. Az yc>@b,L The U.S. Department of Health and Human Services (HHS) is the owner of these certification marks. (4/21/2021), EPC Product, LLC is misrepresenting product manufactured by their company as a NIOSH Approved respirator. TC-84A-8125 is a valid NIOSH approval number. (5/13/2020), This is an example of a counterfeit respirator. These models have not been NIOSH approved since 2015. Feel Safe Mask N95 is NOT NIOSH approved. KN95 masks are manufactured to offer 95% protection from particulate matter, like the N95 mask. 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. The counterfeit respirators use Shanghai Dasheng Health Products Manufacture Co. Ltds NIOSH approval numbers without their permission. Suitable for adults' daily travel protection, the 5-ply foldable face mask has a filtration efficiency of greaterthan/equal 95%, to protect against microns greater than 0.3 in. (4/28/2020), NIOSH did not issue this letter and test report to Shenzhen Ende Medical Technology Co., Ltd. .css-13y9o4w{display:block;font-family:GraphikBold,GraphikBold-fallback,Helvetica,Arial,Sans-serif;font-weight:bold;margin-bottom:0;margin-top:0;-webkit-text-decoration:none;text-decoration:none;}@media (any-hover: hover){.css-13y9o4w:hover{color:link-hover;}}@media(max-width: 48rem){.css-13y9o4w{font-size:1.05rem;line-height:1.2;margin-bottom:0.25rem;}}@media(min-width: 40.625rem){.css-13y9o4w{font-size:1.28598rem;line-height:1.2;}}@media(min-width: 48rem){.css-13y9o4w{font-size:1.39461rem;line-height:1.2;margin-bottom:0.5rem;}}@media(min-width: 64rem){.css-13y9o4w{font-size:1.23488rem;line-height:1.3;}}The Difference Between a Heart Attack and a Stroke, 9 Signs You May Develop Erectile Dysfunction, 6 Harmless Reasons You Can't Get An Erection, Signs You're Having an Existential Crisis, Covid Shots After the Public Health Emergency Ends, A Day in the Life of a (Clueless) Medical Intern, What the Covid Public Health Emergency End Means, What Is a Pulmonary Embolism From 'Succession', I Stopped Reading Political News for 30 Days. 1953 0 obj <> endobj ______________________________, Makrite Hubei Industrial Co., Ltd is a subsidiary of NIOSH approval holder Makrite Industries Inc. You can find a specific manufacturer by clicking on the first letter of their name on the index below. (10/07/19), This is an example of two counterfeit respirators. When it comes to KN95 masks, experts recommend models that filter out at least 95% of particulates, are constructed with ear loops and are comprised multiple layers. Sobmex is marketing numerous filtering facepiece respirators with NIOSH listed on the technical specifications sheet. Breath Buddy is NOT a NIOSH approval holder. 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. The website lists the SEKURA-321 as NIOSH approved with approval number TC-84A-6660. The NIOSH website statesmanufacturers, distributors, suppliers, and importers cannot use these results to make claims about their products. size . Enro masks feature a 99% virus, bacteria, and particle filtration efficiency rate. The NIOSH stylized logo is a registered certification mark owned by HHS. 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.". Baoding Yinhong Yuhe Medical Device Manufacturing Co., Ltd. Changsha Changjiu Medical Technology Co. Ltd. Creative Concepts Manufacturing Ltd. aka Huizhou RD Plastic Co., Ltd. Dongguan Sengtor Plastics Products Co., Ltd. Fujian Leephick Pharmaceutical Industry Co. Ltd. Fuzhou Chunlan Medical Equipment Co., Ltd. Guangdong Nuokang Medical Technology Co., Ltd. KN95 Non-Surgical Disposable Particulate FFR, GUANGZHOU BIOFIL AIR PURIFICATION MATERIALS CO.,LTD, Guangzhou Harley Commodity Company Limited, Guangzhou Powecom Labor Insurance Supplies Co., LTD. Haishi Hainuo Lexiang Medical Technology (Qingdao) Co., Ltd. Hunan Boltpower Guokang Medical Equipment Co., Ltd. Hunan Jianyuan Medical Science and Technology Co. Ltd. Jinwells (Tianjin) Science and Technology Co., Ltd. ORICH Medical Equipment (Tianjin) Co., Ltd. Stereoscopic type ear worn KN95 Protective Mask, Raxwell Industrial Technology (Shanghai) Co., Ltd, Rizhao Sanqi Medical & Health Articles Co., Ltd, RIZ100CVb, 3Q KN95, 3Q FFP2 NR, RIZQ100Sb, 3Q KN95 9505, Shandong Yuerong Network Technology Co., Ltd. Shanghai Dasheng Health Products Manufacture Company, Ltd. Shanghai Gangkai Purifying Products Co. Ltd. Shenyang Shengshi Medical Technology Co., Ltd. Shenzhen SanheXing Stickers Products Co., Ltd. Shenzhen Yunyifu Health Technology Co., LTD. Suzhou Bolisi Medical Technology Co., Ltd, Suzhou Sanical Protective Product Manufacturing Co., Ltd, FFP2 NR E-300, FFP2 NR E-680, FFP2 NR 952, FFP2 NR F-820, KN95 958, KN95 951, FFP3 NR E-830V, FFP3 NR E-340V, FFP2 NR K-220. 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. 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. However, you dont have to toss a KN95 mask after a single use. 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. NIOSH does not approve KN95 products or any other respiratory protective devices certified to international standards. 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. So if you see the phrases FDA-approved or NIOSH-approved on the packaging of KN95 masks, its a red flag. The NIOSH website statesmanufacturers, distributors, suppliers, and importers cannot use these results to make claims about their products. They come in a pack of 40, are built with an adjustable nose clip, and come in colors like white, black and grey. Regardless of the type of mask you wear, it wont protect you or the people around you unless you wear it correctly. 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. 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. HUKsFWHHL&36S'f7,&W8KJjSu X,v_v]V}_ CYm!^a0;?5/fba~y@+eY}%xKoA; qhI$h# {#cT;/1XgoQxN,Wf;NxYt_)SfEbC43HNPJ!#9("u (3/12/2020), This is an example of a misrepresentation of the NIOSH approval. GWT respirators bearing any NIOSH approval number listed on the user notice isnotNIOSH approved. All information these cookies collect is aggregated and therefore anonymous. (8/25/2020), This is an example of a misrepresentation of a NIOSH approval. 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). Additionally, Raxwell Industrial Technology Co., Ltd. is misrepresenting Raxwell model RX9501P N95 as a NIOSH Approved respirator. The Osprey N95 particulate respirator is not NIOSH approved. The FDA no longer reviewed requests to add new respirator models to Exhibit 1 of this EUA after March 24, 2021. U-SAFE models B120 and B130 N95 particulate respirator are not NIOSH approved. However, the manufacturer, Anhui Tongcheng YaGe Health Materials, Co., Ltd, is not a NIOSH approval holder. Additionally, an abbreviated approval label is on the filtering facepiece respirator (FFR) itself or straps. Using a fitter or brace is especially a good idea for people with facial hair, which can make it difficult to achieve a tight fit. Pure&Safe is not a NIOSH approval holder or a private label assignee. These are examples of counterfeit respirators. NIOSH National Personal Protective Technology Laboratory. Surgical masks also dont fit as snugly as N95 or KN95 masks, so their protection is not as strong. A well-fitted N95 face mask will help reduce the transmission of the virus. It later ended the EUA because NIOSH-approved respirators were no longer in short supply. This product is no longer compliant to the NIOSH approval and sold without Safe Life Corporations permission. 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. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Although they appear to be from NIOSH, these documents include alterations and false information. The NIOSH stylized logo is a registered certification mark owned by HHS. The wording on their website is misleading and not accurate. PDF, Image. These markings indicate a quality. Fits securely over face: to prevent shifting during movement.