A real KF94 is made in South Korea, and a KN95 made according to the latest standards should be stamped with "GB2626-2019," Wirecutter reports. The 8 Best Face Masks of 2023 | by Health It has four protective layers, two headbands, and an adjustable nose bridge wire. (10/07/19), This is an example of two counterfeit respirators. Users cannot use this filter in place of the filter component associated with the NIOSH Approved respiratory protective device. Powecom's KN95 masks were featured on the FDA's EUA list. Masks are disposable and cannot be washed or reused. Get answers to commonly asked questions about NIOSH Approved respirators and counterfeits. ), SKIP AHEAD What is a KN95 mask? Parents will love that the mask has a 95 percent filtration rate and can be reused up to 50 times. The NIOSH approval label, which you can find on or within the respirator packaging, includes the TC approval number. The mask features double-welded head straps with an adjustable nose piece to provide a strong fit and seal against the wearers face. 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. 1*2={Z:4l#H2 b 0@>?Cz9Xsie^ The Moaron 2091 P100 filter is NOT a component associated with a NIOSH approval. ~p.`QFFX%A._}Ba) .k[xx1qIbs6e)IOd#L) NDdUd}1|" Both counterfeit and misrepresented respirators may not be capable of providing the appropriate or necessary respiratory protection to workers and users. However, please take extra precautions when purchasing to ensure you receive the authentic product and not the counterfeit version. In their guide to masks and respirators, the CDC further prioritized respirators above masks with emphasis on a proper fit and specified theyre better than cloth products. (12/3/2020), This is an example of a misrepresentation of a NIOSH approval. 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. (5/13/2020), This is an example of a counterfeit respirator. Moaron is not a NIOSH approval holder; P100 is a registered certification mark owned by HHS. 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. The masks come in six different sizes that range from XXS to XL. This disposable face mask has a three-layer protection made of soft breathable material. NIOSH entered a Memorandum of Understanding (MOU) in 2018 with the Food and Drug Administration (FDA). 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. | How to wear a KN95 mask. Shining Star Electronic Technology Co., Ltd. Shanghai Gangkai Purifying Products Company, Ltd. MSA do Brasil Equipamentos e Instrumentos de Seguranca Ltd.a. FitSeal, is not a NIOSH approval holder or a private label holder. 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. Taylyn Washington-Harmon is a writer and editor based in Chicago. They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. (8/25/20), This is an example of a misrepresentation of a NIOSH Approved product. endstream endobj startxref endstream endobj 1957 0 obj <>stream This counterfeit respirator uses NIOSH approval holder Shining Star Electronic Technologys NIOSH approval number (TC-84A-8125, model SS6001-N95) without their permission. 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. Please refer to ouruser noticefor more information. (2/18/2021), Raxwell Industrial Technology Co., Ltd. is misusing NIOSH test information regarding Raxwell model RX9501 KN95 Face Masks. Introduced in the US market in response to the Corona virus pandemic and approved for use under the CDC's EAU, the KN95 is currently being used for protection against Covid-19. View official letters announcing NIOSH polices, notices for users (e.g., changes in a respirators approval status), and more. Additionally, the FDA, in collaboration with CDC's NIOSH, increased surveillance and sampling of all respirators imported from China. But theyre harder to shop for heres what to know. The counterfeit respirator uses a 3M TC number (TC 84A-0427) without 3Ms permission. 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. They are available in black and white, as well as multiple colors, all of which come in a pack of 10. They are counterfeit, or they are no longer compliant to the NIOSH approval. The FDA no longer reviewed requests to add new respirator models to Exhibit 1 of this EUA after March 24, 2021. Subscribe to NPPTLs listservto stay informed about changes to a respirators approval status and other relevant notifications. 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. For more information, view, Private label of Foss Manufacturing Company. (8/25/2020), This is an example of a misrepresentation of a NIOSH approval. The Osprey N95 particulate respirator is not NIOSH approved. 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. All information these cookies collect is aggregated and therefore anonymous. 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. endstream endobj 1958 0 obj <>stream These markings indicate a quality. Report Counterfeit or Misrepresented Respirators, Centers for Disease Control and Prevention. CDC twenty four seven. 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. hVQo6+|l2HJ@v,s#TI0jm$ww`4c Buyer's Guide to KN95 Respirator Masks: 7 Things to know Model TY 0424 is not NIOSH approved. Price at time of publication: $75 Product Details: Type of. Valpro Safety uses 3Ms approval number (TC-84A-0007) to sell the Ranger 821 and Ranger 821V respirators. 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. However,. The 10 Best Eye Masks for Sleeping of 2023, 13 Lightweight Face Masks for More Airflow and Less Glasses Fog, Finding the Best KF94 Masks and Where To Buy One, The 9 Best Earplugs for Sleeping for 2023, Tested and Reviewed, How to Know if Your N95 Mask Is Counterfeit or Real, The CDC's New Mask Guidance Recommends Double-Masking and a Tighter FitHere's the Latest, The 12 Best Sports Bras for Support and Comfort, covers your mouth and nose while fitting under your chin, National Institute for Occupational Safety and Health. You can follow her on Twitter and Instagram at @taylynharmon. (3/12/2020), This is an example of a misrepresentation of the NIOSH approval. NIOSH received this product through an International Respirator Assessment request. WellBefore offers KN95 masks in multiple colors and allows a choice between standard ear loops and head straps. Why We Like It: The shape naturally conforms to the wearers face to allow for comfortable talking and facial movement. Zhengzhou Ruipu Medical Technology Co., Ltd. is not a NIOSH approval holder or a private label holder. Nor does the inclusion of the donning procedure or user instructions included on the website and PDF versions. Dongguan AOXING is not a NIOSH approval holder or a private label assignee. It states the respirator is manufactured by Benehal China, who is not a NIOSH approval holder. The NIOSH website states manufacturers, distributors, suppliers, and importers cannot usethese results to make claims about their products. Experts have repeatedly stressed that masks help reduce the risk of viral transmission. Farah Khan, MD, is an allergist/immunologist that treats pediatric and adult patients in her private practice in Northern Virginia. Shenzhen Ende Medical Technology Co., Ltd. is not a NIOSH approval holder. Find helpful customer reviews and review ratings for Kingfa KN95 Face Mask 50 Pcs Disposable Respirator 5-Ply Layer | GB2626-2019 Compliant at Amazon.com. 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 . Ltd. is not a NIOSH approval holder or a private label holder. KN95 masks are made abroad in China, thus adhering to Chinese standards. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. According to the CDC, as many as 60 percent of KN95 masks available could be fakes. UPDATE (Aug. 26, 2021, 5:45 p.m.): A previous version of this article included the VIDA KN95 face mask. Only manufacturers who are NIOSH approval holders may use these registered certification marks in accordance with applicable laws. N95 is a registered certification mark owned by HHS. 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. Yamada brand masks, including models 5241 and 8242, are not NIOSH approved. If so, it will void the NIOSH approval. (6/3/2020), Translation of letter: Makrite Hubei Industrial Co., Ltd has not signed any purchase contracts or agreement with any company or issued any distribution authorization. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Its Worth Noting: The masks are not individually wrapped, so they may be hard to carry as spares when out and about. The NIOSH website statesmanufacturers, distributors, suppliers, and importers cannot use these results to make claims about their products. Wwdoll KN95 Face Mask, Pack of 25, $28.74 (orig. 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. PitBull Safety Products is not a NIOSH approval holder nor are they a NIOSH private label holder. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage: Strategies for Optimizing the Supply of N95 Respirators. Xiantao Fushi Protective Products Co., Ltd. is not a NIOSH approval holder or a private label holder. (5/14/2020), The website, www.covidness.net, misrepresents these two examples of respirators as NIOSH approved. See the Notes section for information about private labels. The NIOSH stylized logo is a registered certification mark owned by HHS. An official website of the United States government, : These companies cannot use this certification mark because this is not a NIOSH Approved respirator. We offer a range of different types of face masks that fit various budgets and various levels of protection. Why We Like it: The mask comes in six different sizes with adjustable nose and ear loops. The NIOSH website statesmanufacturers, distributors, suppliers, and importers cannot use to make claims about their products. $47.42) ChiSip KN95 Face Mask, Pack of 20 . Chengde Technology Co., Ltd. markets the product using results from the assessment. They help us to know which pages are the most and least popular and see how visitors move around the site. Previously FDA-Approved KN95 Face Masks. Another factor to consider while shopping for KN95 masks is FDA registration. Each Covid-19 Community Level corresponds to a masking recommendation suggested precautions increase alongside the level. hb```f``zAXX&ACl`PxA>Qq L[c{nZ`_ M2K<2]i@`fUU @h$l8pP]%W%W'9@h$,!aN$T[$Tqs.l 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. Check if the manufacturer is listed here. Why We Like it: This KN95 mask is lightweight and comfortable, plus it comes in multiple colors. This MOU granted NIOSH the authority to approve surgical N95 filtering facepiece respirators. (Most people use mask and respirator interchangeably, but when the CDC and medical professionals say respirator, they specifically mean specialized, fitted face coverings like N95s, KN95s and KF94s. However, you dont have to toss a KN95 mask after a single use. N95 is a registered certification mark owned by HHS. Fido Industrial Safety Masks Manufacturer Company, Ltd. National Institute for Occupational Safety and Health, Respirator Assessments to Support COVID-19 Response, Beyond Shelf Life/Stockpiled Assessment Results, Non-NIOSH Approved Innovative Filtering Facepiece Respirator Assessment Results, Healthcare Respiratory Protection Resource, Support for Firefighter Personal Protective Equipment, Participation on Standards Setting Organizations, Considerations for Selecting Protective Clothing, NPPTL Participation in Standard Development Committees, Respiratory Protection Information Trusted Source, Approved Particulate Filtering Facepiece Respirators, Conformity Assessment Notices and Letters to Respirator Manufacturers and Interested Parties, U.S. Department of Health & Human Services, A respirator labeled as a KN95 respirator is expected to conform to Chinas GB2626 standard. 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 Additionally, respirators from the box include the CE (European) approval mark and NIOSH N95. 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. 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. Any N95 filtering facepiece respirators for sale accompanied by this letter areNOT NIOSH approved. Sobmex does not have permission to use this certification mark because this is not a NIOSH Approved respirator. Learn more about signs that a mask is a counterfeit through CDC resources here. 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. Its Worth Noting: Newer masks may run larger than previous batches. 9.":NBG1`L,i!P(7\,Dbe b@;hh 2;rH(W0B4GdJR'+]6 G Buy FDA facility approved GB2626-2006 Standard KN95 face mask, 50 units, to stay safe from dust, pollution and diseases. NIOSH may pursue enforcement action. Prior to this MOU, both NIOSH and FDA approved and cleared surgical N95s. (3/26/2021), SS Paper Convertors is misrepresenting protective masks as NIOSH approved. The second example is MIUTON. To determine your areas Covid-19 Community Level, use the CDC's Covid-19 county check. Masks produced after July 1, 2021, bear the standard number. Nor does NIOSH approve any other respiratory protective device solely certified to international standards. While reviewing the various face masks on the market, we took into account whether the mask is NIOSH- and FDA-approved, the level of protection, the cost-effectiveness, the comfort, and the ease of use and breathing. Although they appear to be from NIOSH, these documents include alterations and false information. The site is secure. INSAFE is not a NIOSH approval holder or a private label holder. 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. Adobe d '$''''$25552;;;;;;;;;; Some brands publish these online, while others may send them to you if you ask. GWT respirators bearing any NIOSH approval number listed on the user notice isnotNIOSH approved. View the user notice announcing the rescission. Xiantao Fushi Protective Products Co., Ltd. do not have permission to use this mark because this is not a NIOSH Approved respirator. 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. Vogmaskis not a NIOSH approval holder. Additionally, an abbreviated approval label is on the filtering facepiece respirator (FFR) itself or straps. Cookies used to make website functionality more relevant to you. Raxwell Industrial Technology Co., Ltd. is not a NIOSH approval holder or a private label holder. The NIOSH stylized logo is a registered certification mark owned by HHS. When it comes to . No certificate of approval was provided with the samples received; therefore, the authenticity of the claims cannot be validated. 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. 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. Check out more tips to spot counterfeit respirators. (10/07/2019), No markings at all on the filtering facepiece respirator, No approval (TC) number on filtering facepiece respirator or headband, Presence of decorative fabric or other decorative add-ons (e.g., sequins), Claims approval for children (NIOSH does not approve any type of respiratory protective device for children at this time). To learn more about how to identify a NIOSH Approved FFR, check out the fact sheet and graphic below. (2/26/2021), Zhengzhou Ruipu Medical Technology Co., Ltd. is misusing NIOSH test information regarding RUIPU RIPE DOCTORS KN95. With a 95 percent filtration rate, N95 masks reduce the wearer's exposure to particles including small particle aerosols and large droplets. Find NIOSH Approved particulate filtering facepiece respirators and their donning instructions. How to shop for medical masks like N95s, KN95s and KF94s and how - NPR They provide customers with a shipping label so used masks can be sent back to their facility. (11/6/2019), This product is not NIOSH approved. A respirator labeled as a KN95 respirator is expected to conform to China's GB2626 standard. (5/26/2021), This is an example of a misrepresentation of a NIOSH approval. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. 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. The ear loop of this mask is made of a highly stretchable soft material that is latex-free. Friese added that a KN95 mask generally offers more protection than double-masking anyway, as long as it fits well. How to Spot a a Fake N95 or KN95 Mask? - News @ Northeastern They can be worn on a day-to-day basis in any environment. GUANGDONG GOLDEN LEAVES TECHNOLOGY DEVELOPMENT CO., LTD. Personal Protective Equipment EUAs | FDA Example of correct exterior markings on a NIOSH Approved filtering facepiece respirator. Filtering facepiece respirator has ear loops instead of headbands. Why We Like it: These fun, colorful masks feature a unique parrot design that makes them comfortable for kids to wear. Monica Gandhi, MD, MPH, Director of UCSF-Bay Area Center for AIDS Research (CFAR), recommends N95, KN95, KF94, FFP2, or double-masking while indoors to block respiratory pathogens. Anyone claiming that they have authorization or a purchase contract with Makrite Hubei Industrial Co., Ltd is forgery and infringement. According to the CDCs recent guidance, masks should be worn when there is a high level of COVID in your community. Surgical N95 respirators approved under the MOU do not require FDAs 510(k) clearance. Saving Lives, Protecting People, The National Personal Protective Technology Laboratory (NPPTL), Respiratory Protection Information Trusted Source, Shanghai Dasheng Health Products Manufacture Co., Ltd issued a user notice for select lots of the DUKAL, View the user notice announcing the rescission, National Institute for Occupational Safety and Health, Respirator Assessments to Support COVID-19 Response, Beyond Shelf Life/Stockpiled Assessment Results, Non-NIOSH Approved Innovative Filtering Facepiece Respirator Assessment Results, Healthcare Respiratory Protection Resource, Support for Firefighter Personal Protective Equipment, Participation on Standards Setting Organizations, Considerations for Selecting Protective Clothing, NPPTL Participation in Standard Development Committees, Approved Particulate Filtering Facepiece Respirators, Conformity Assessment Notices and Letters to Respirator Manufacturers and Interested Parties, U.S. Department of Health & Human Services, These areexamples of misrepresentation of the NIOSH approval. We take your privacy seriously. ______________________________, Makrite Hubei Industrial Co., Ltd is a subsidiary of NIOSH approval holder Makrite Industries Inc. The maximum and minimum filter efficiency was 99.00% and 98.31%, respectively. View larger version. Keep in mind face masks come in all different shapes and sizes. The counterfeit respirators use Shanghai Dasheng Health Products Manufacture Co. Ltds NIOSH approval numbers without their permission. This model has not been NIOSH approved since 2017. meets GB2626-2006 (the Chinese standard for Respiratory Protective Equipment - Non-Powered Air-Purifying Particle Respirator). They work together to block out more than 95 percent of particles. These masks also feature an adjustable nose bridge. Rich Scherr is an updates strategist and fact checker for Dotdash Meredith brands, including Health and Verywell. (2/18/2021), This is an example of a misrepresentation of a NIOSH Approved product. Part 84. Models sold by EPC, including but not limited to, PT-N95F-01, PT-N95C-02, and PT-N95CS-02 are NOT NIOSH approved. 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. If you dont have an N95 or KN95 mask, a surgical mask is the next best option. 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. Weve removed it from the list because the brand is shipping M95 face masks for some orders of KN95 face masks given "global shortages," according to its site. "1AQSTaqB Medicos is selling an N95 respirator using the Moldex approval number and label without Moldexs permission. 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. 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. Huizhou Green Communication Equipment Manufacturing Co., Ltd. is not a NIOSH approval holder or a private label assignee. VIDA has a sustainability program to help ensure the masks get properly recycled. (11/5/2021), Dongguan AOXING is misusing NIOSH test information for its KN95 Protective Mask model AX-KF95. KN95 Protective Face Mask GB2626 Standard, Black (5-Pack) - The Home Depot KN95 masks are manufactured to offer 95% protection from particulate matter, like the N95 mask. Products labeled as DermaCare or Espomega, with model numbers HY8710, HY8812, and HY8816, are NOT NIOSH approved. (2/4/2021), This is an example of a misrepresentation of a NIOSH approved product. This is the official listing of all NIOSH Approved respirators. 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). Good Mask Co. markets the mask using results from the assessment. When you visit the site, Dotdash Meredith and its partners may store or retrieve information on your browser, mostly in the form of cookies. Chengde Technology Co., Ltd. is not a NIOSH approval holder or a private label holder. The U.S. Department of Health and Human Services (HHS) is the owner of these certification marks. At Select, we work with experts who have specialized knowledge and authority based on relevant training and/or experience. (4/9/2020), This is an example of a counterfeit respirator. List of NIOSH Approved Filtering Facepiece Respirators. 0 Historical information regarding these EUAs can be found on Historical Information about Device Emergency Use Authorizations. (12/18/2020), This is an example of a misrepresentation of a NIOSH approved product. 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. Zhengzhou Ruipu Medical Technology Co., Ltd. advertises the product using results from the assessment.
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