Dongguan AOXING is marketing product using results from the assessment. 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); The logo is wrong, there is no approval number (TC-84A-xxxx). NIOSH may pursue enforcement action. This counterfeit respirator uses NIOSH approval holder Shining Star Electronic Technologys NIOSH approval number (TC-84A-8125, model SS6001-N95) without their permission. Web links in the table go to the NIOSH Approval Holders website. (1/4/2019). The KN95 mask could be an effective method of protection against airborne pathogens. Nor does the inclusion of the donning procedure or user instructions included on the website and PDF versions. N95 is a registered certification mark owned by HHS. Its Worth Noting: VIDA masks are non-washable and should be replaced on a daily basis. 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. efH3~#mM3IrNeYvbPF?$8}'|Oqq6_@Of|\CJq%Zq1. At Select, we work with experts who have specialized knowledge and authority based on relevant training and/or experience. NIOSH also provides a table of the surgical N95 respirators approved prior to the MOU. Manufacturers for masks from Evolvetogether, Hope Health and Well Before are not on the list, but are only registered with the FDA. NIOSH posts information about misrepresented and counterfeit respirators here to alert users, purchasers, and manufacturers. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage: Strategies for Optimizing the Supply of N95 Respirators. meets GB2626-2006 (the Chinese standard for Respiratory Protective Equipment - Non-Powered Air-Purifying Particle Respirator). Xiantao Fushi Protective Products Co., Ltd. is not a NIOSH approval holder or a private label holder. Dongguan AOXING is not a NIOSH approval holder or a private label assignee. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Thank you for taking the time to confirm your preferences. Hearst Magazine Media, Inc. All Rights Reserved. (6/19/19), This is an example of a counterfeit respirator. But theyre harder to shop for heres what to know. SafeShields marketing of model FS-N95 is misleading and may cause users to believe it is NIOSH approved. We took the experts' recommendations into consideration alongside the recommendations of the CDC when picking each face mask listed. However, the manufacturers website continues to state the ViraMask N99ESC is NIOSH certified. UPDATE (Aug. 26, 2021, 5:45 p.m.): A previous version of this article included the VIDA KN95 face mask. Protect yourself from dust and pollution long-time and avoid any unconfirmed or eye fogging. The product package indicates it meets Chinese standard GB 2626-2006 and submitted to NIOSH under an International Respirator Assessment request. The NIOSH stylized logo is a registered certification mark owned by HHS. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 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. Its Worth Noting: These masks are on the smaller side, so they may not be a good choice for people with large faces. Cookies used to make website functionality more relevant to you. WWDOLLs KN95 masks were also featured on the FDAs EUA list. Evolvetogethers KN95 masks come in a pack of five and are individually wrapped in what the company has said are biodegradable pouches. What is a KN95 respirator mask? All . ! 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. Adobe d '$''''$25552;;;;;;;;;; N95 and NIOSH Approved are certification marks of the U.S. Department of Health and Human Services (HHS) registered in the United States and several international jurisdictions. Additionally, Moaron incorrectly advertises that it is compatible with other NIOSH approved products. SS Paper Convertors is not a NIOSH approval holder or private label holder. KN95 Protective Face Mask GB2626 Standard (10-Pack) Protect yourself from airborne dust, pollen Protect yourself from airborne dust, pollen and other allergens with the KN95 Protective Face Mask from SUPPLYAID. SOUND is not a NIOSH approval holder or a private label holder. Experts and the CDC recommend wearing a mask that covers your mouth and nose while fitting under your chin. hbbd``b`>$S8`9$@\F q b``$@ P (2/10/2020), There are no markings on the face of the respirator. 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. endstream endobj startxref 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. These cookies may also be used for advertising purposes by these third parties. Since they sell out quickly and can be hard to come by, many people have turned to the Chinese equivalent, KN95 masks, instead. Respirators and replacement cartridges and filters marked as Zelbuck are NOT NIOSH approved. Sobmex is marketing numerous filtering facepiece respirators with NIOSH listed on the technical specifications sheet. 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. The NIOSH stylized logo is a registered certification mark owned by HHS. Farah Khan, MD, is an allergist/immunologist that treats pediatric and adult patients in her private practice in Northern Virginia. Valpro Safety uses 3Ms approval number (TC-84A-0007) to sell the Ranger 821 and Ranger 821V respirators. The wide elastic ear loops provide comfort and do not irritate behind the ears when wearing the mask for a long period. Why We Like it: It filters out more than 98 percent of airborne particles and is made in the United States. 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. Although Kingfa has products listed on the FDA website as approved for use in the US under the EUA, those are for models: KF-A F01 and KF-A . View the user notice announcing the rescission. The 5-ply foldable KN95 mask has over 95% filtration . Additionally, the TC number belongs to a 3M full facepiece respirator with cartridges. For all of the masks below, weve obtained associated lab tests regarding filtration. Additionally, Health Protective is misusing NIOSH test information. KN95 masks are disposable face coverings, so you cant wash and reuse them like you can a cloth mask. However, you dont have to toss a KN95 mask after a single use. Prior to this MOU, both NIOSH and FDA approved and cleared surgical N95s. 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. (12/1/2021), This is an example of a misrepresentation of a NIOSH approval. Additionally, if you knowingly come into close contact with someone infected with Covid, or you yourself have Covid while wearing it, you should throw the mask out after a single use. 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). These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Zelbuck is not a NIOSH approval holder or a private label holder. (4/30/2021), This is an example of a misrepresentation of a NIOSH approval. The CDC has said you should not double-mask while wearing a KN95 mask. 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%. Please provide the following details with your email: The NIOSH stylized logos (shown below), N99, N100, R95, P95, P100, PAPR100-N, PAPR100-P, and HE are certification marks of the U.S. Department of Health and Human Services (HHS) registered in the United States. 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. However, the manufacturer, Anhui Tongcheng YaGe Health Materials, Co., Ltd, is not a NIOSH approval holder. NIOSH also registered the certification marks N95, N99, N100, P95, R95, P100, PAPR100-N, PAPR100-P, HE, and NIOSH Approved with the USPTO. The mask features double-welded head straps with an adjustable nose piece to provide a strong fit and seal against the wearer's face. Sobmex does not have permission to use this certification mark because this is not a NIOSH Approved respirator. If so, it will void the NIOSH approval. The Moaron 2091 P100 filter is NOT a component associated with a NIOSH approval. CDC twenty four seven. Masks are disposable and cannot be washed or reused. 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. 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. As the federal entity responsible for the Respirator Approval Program, NIOSH is the custodian of these certification marks. Guangzhou Bofeite Safety Protective Supplies Co., Ltd. UHEALTH MEDICAL (BEIJING) PROTECTIVE PRODUCTS CO., LTD. Jingzhou Strong Sciences & Technology Development Co.,ltd. Additionally, Good Mask Co. is misusing NIOSH test information. U-SAFE does not have permission to use this certification mark because this is not a NIOSH Approved respirator. (8/7/2020), NIOSH received notice of websites selling and misrepresenting Safe Life model B130 and model B150 as NIOSH approved. (10/22/2020) Megha International is not a NIOSH approval holder or private label assignee. Find NIOSH Approved particulate filtering facepiece respirators and their donning instructions. They come in a pack of 25 and are available in multiple colors. 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. Experts have repeatedly stressed that masks help reduce the risk of viral transmission. All information these cookies collect is aggregated and therefore anonymous. He is a seasoned financial and technology journalist who served as editor-in-chief of the Potomac Tech Wire for nearly two decades, and is a regular contributor to the sports pages of The Baltimore Sun. For masks that appeared on the FDAs EUA, we got documentation from the. Zoe Malin is an associate updates editor for Select on NBC News. Search for NIOSH Approved respirators. Our KN95 masks for sale are FDA approved and CE certified, genuine, and made following industry standards. 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. Friese added that a KN95 mask generally offers more protection than double-masking anyway, as long as it fits well. Shapiro said she wouldnt wear a KN95 more than three or four times maximum, especially if doing so for multiple hours. Masks absolutely have expiration dates. Nor does NIOSH approve any other respiratory protective device solely certified to international standards. (10/23/2019), This is anexample of misrepresentation of the NIOSH-approval. (7/16/2020), This is an example of counterfeit respirators. Moaron is not a NIOSH approval holder; P100 is a registered certification mark owned by HHS. 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. You can review and change the way we collect information below. Pasture Pharma did not manufacture this counterfeit respirator. Shapiro said KN95s should be stored in a paper bag between uses. The Model Number/Product Line in bold text followed by (FDA) indicates these surgical N95 respirators in the table below. Nor are they a private label holder. The cost of N95 face masks can vary depending on where the masks are purchased, the quality of the masks, and if its being purchased as a singular mask or a pack of masks. This face mask can also be washed up to 100 times in the washing machine, which makes it one of the most sustainable face masks. Buy FDA facility approved GB2626-2006 Standard KN95 face mask, 50 units, to stay safe from dust, pollution and diseases. 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. Taylyn Washington-Harmon is a writer and editor based in Chicago. No certificate of approval was provided with the samples received; therefore, the authenticity of the claims cannot be validated. NIOSH entered a Memorandum of Understanding (MOU) in 2018 with the Food and Drug Administration (FDA). The NIOSH stylized logo is a registered certification mark owned by HHS. See the Notes section for information about private labels. "1AQSTaqB KN95 GB2626-2006 Today we introduce our newest product, the KN95 Respirator Mask to the Chinese standard GB2626-2006. 'p^c8EN%VR[44g EtglF This item: Kingfa KN95 Face Mask 50 Pcs Disposable Respirator 5-Ply Layer | GB2626-2019 Compliant $14.99 ($0.30/Count) Hotodeal KN95 Face Mask 20 PCS,5 Layers Cup Dust Mask Against PM2.5 from Fire Smoke, Dust, for Men, Women, Essential Workers (Grey) $19.99 ($1.00/Count) HUKsFWHHL&36S'f7,&W8KJjSu X,v_v]V}_ CYm!^a0;?5/fba~y@+eY}%xKoA; qhI$h# {#cT;/1XgoQxN,Wf;NxYt_)SfEbC43HNPJ!#9("u Read honest and unbiased product reviews from . 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.". Ltd. is not a NIOSH approval holder or a private label holder. Subscribe to NPPTLs listservto stay informed about changes to a respirators approval status and other relevant notifications. 2020-2040 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product "FFP2 PROTECTIVE MASK GB2626-2006 (CIVIL GRADE) 5 LAYERS KN95" They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. Chengde Technology Co., Ltd. is not a NIOSH approval holder or a private label holder. 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. This product is no longer compliant to the NIOSH approval and sold without Safe Life Corporations permission. The company references NPPTL testing claims , using an image of the test setup from the assessment. The masks come in six different sizes that range from XXS to XL. 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^ Some brands publish these online, while others may send them to you if you ask. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Intech Safety Pvt. Feel Safe Mask N95 is NOT NIOSH approved. A legitimate KN95 should also be stamped with text, including the name of the manufacturer, the model, and "GB2626-2019," which is a reference to a quality control standard approved by the. Surgical masks also dont fit as snugly as N95 or KN95 masks, so their protection is not as strong. (8/25/20), This is an example of a misrepresentation of a NIOSH Approved product. "If GB ends in 2006 its still legit if not [past the expiration date]. You can review and change the way we collect information below. This product may also appear as a misrepresentation of NIOSH approval. 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. Face masks, particularly high-filtration N95s and KN95s, were once a hot commodity during the pandemic. This web page provides a table of NIOSH-approved N95 respirators listed by manufacturer from A-Z. GUANGDONG GOLDEN LEAVES TECHNOLOGY DEVELOPMENT CO., LTD. Look at the markings on the front. 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. 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. Chengde Technology Co., Ltd. is not a NIOSH approval holder or a private label assignee. The website misrepresents it as NIOSH certified but is not NIOSH approved. 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. This list is reviewed and updated weekly. Our KN95 masks are composed of a 6 ply design of meltblown and spunbond polypropylene. Shenzhen Ende Medical Technology Co., Ltd. is not a NIOSH approval holder. Zhengzhou Ruipu Medical Technology Co., Ltd. is not a NIOSH approval holder or a private label holder. N95 is a registered certification mark owned by HHS. The KN95 masks come in multiple colors, and you can also purchase a color variety set, which comes with 15 KN95 masks. A KN95 marked with a "GB" number ending in . However,. The Breath Buddy Particulate Filter is NOT a component associated with a NIOSH approval. 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. If you click on links we provide, we may receive compensation. N95 is a registered certification mark owned by HHS. *UPDATE Shanghai Dasheng Health Products Manufacture Co., Ltd issued a user notice for select lots of the DUKALTMN95 respirator. 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. %PDF-1.6 % Additionally, respirators from the box include the CE (European) approval mark and NIOSH N95. 1953 0 obj <> endobj 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. The first error is that they claim the N95 respirator is 96% efficient. They are falsely indicating product can be used with half and full facepieces made by other NIOSH approval manufacturers. 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. a board certified internal medicine doctor based in San Francs, shows you how to determine whether the masks you bought is real or counterfeit and what to look for to determine real masks from fakes. Check if all the masks are identical and there aren't any mix-ups. S TX%Z1dS8*B0 V KV>NRy+zSLHSb(}-/7-R2D 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9480V (FFP2). Additionally, there are two errors on the respirator package. (11/6/2019), This product is not NIOSH approved. 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. You can also purchase individually packaged KN95s. The Osprey N95 particulate respirator is not NIOSH approved. The product package indicates it meets Chinese standard GB 2626-2006 and submitted to NIOSH under an International Respirator Assessment request. The CDC also has a list of NIOSH-approved manufacturers to ensure your mask is certified for your protection. They are available in black and white, as well as multiple colors, all of which come in a pack of 10. While all masks and respirators provide some level of protection, properly fitted respirators provide the highest level of protection, the CDC noted. Changshu City Hengyun Nonwoven Products Co., Ltd. is not a NIOSH approval holder or a private label assignee. WellBefore offers KN95 masks in multiple colors and allows a choice between standard ear loops and head straps. Both counterfeit and misrepresented respirators may not be capable of providing the appropriate or necessary respiratory protection to workers and users. Pure&Safe is not a NIOSH approval holder or a private label assignee. These respirators filter out 95 percent of particles that are 0.3 microns or larger in diameter, Dr. Michael Schivo, a pulmonologist and an associate professor of internal medicine at UC Davis Health, previously told Men's Health. U-SAFE is not a NIOSH approval holder or a private label assignee. 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 and Health (NIOSH) and that met eligibility criteria as described in the EUA. The NIOSH website statesmanufacturers, distributors, suppliers, and importers cannot use these results to make claims about their products. 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. Many shoppers have noted how well the mask can be molded to properly fit their faces. This content is imported from Tiktok. Get answers to commonly asked questions about NIOSH Approved respirators and counterfeits. (2/18/2021), Chengde Technology Co., Ltd. is misusing NIOSH test information regarding WWDOLL model CD9501B KN95 Foldable Protective Masks. Our KN95 masks are FDA registered and meet Chinese standard GB2626-2006 and/or GB2626-2019 as applicable. For an optimal experience visit our site on another browser. It later ended the EUA because NIOSH-approved respirators were no longer in short supply. We independently evaluate all recommended products and services. . (12/3/2020), This is an example of a misrepresentation of a NIOSH approval. NIOSH is the National Institute for Occupational Safety and Health (NIOSH) in the U.S., providing the standards for protective N95 face masks across several occupations that require them. Stella Clavecillo, D.O. 2023 SELECT | All rights reserved. (9/9/2021), This is an example of a misrepresentation of a NIOSH approval. Megha International does not have permission not use this certification mark because this is not a NIOSH Approved respirator. The counterfeit respirator uses a 3M TC number (TC 84A-0427) without 3Ms permission. Surgical N95 respirators approved under the MOU do not require FDA's 510 (k) clearance. These respirators were authorized for use by healthcare personnel in healthcare settings in accordance with the CDC's recommendations. Products labeled as DermaCare or Espomega, with model numbers HY8710, HY8812, and HY8816, are NOT NIOSH approved. 0e$Yp59 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 strong ear loop wont break as easily as other disposable face masks. (11/6/2019), Images here are examples of counterfeit respirators and sold as if they are NIOSH approved.

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