Look at the markings on the front. Masks produced after July 1, 2021, bear the standard number. The mask must be snug on your face while allowing you to breathe easily. It filters 95% of particulate matter, just like the N95 mask, explained Dr. Nina Shapiro, a pediatric ear, nose and throat specialist at Westside Head and Neck in California. Masking up also protects other people, as demonstrated in numerous studies like these gathered by the CDC. All respirator shipments from China that came into the U.S. were subject to random sampling and testing by CDC's NIOSH to determine whether the respirator meets the expected particulate filtration standards. The ultra-lightweight mask also provides comfort that helps wearers breathe easier, even while running and exercising. To recommend when Americans should wear face masks, the CDC determines an areas Covid-19 Community Level risk on a scale of low, medium or high. Experts told us that transparency regarding face masks is a must-have in any brand you shop. 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a list of non-NIOSH-approved respirator models manufactured in China that were authorized at the time this Umbrella EUA was revoked. The counterfeit box is glossy and primarily green, and the package contains 2 stacks of 10 units. Manufacturers for masks from Evolvetogether, Hope Health and Well Before are not on the list, but are only registered with the FDA. Nor does the inclusion of the donning procedure or user instructions included on the website and PDF versions. With a 95 percent filtration rate, N95 masks reduce the wearer's exposure to particles including small particle aerosols and large droplets. SOUND is not a NIOSH approval holder or a private label holder. How do you know which masks are legit, and even more so where to get one? Valpro Safety uses 3Ms approval number (TC-84A-0007) to sell the Ranger 821 and Ranger 821V respirators. More information is available on the Respiratory Protection Information Trusted Source. Chengde Technology Co., Ltd. is not a NIOSH approval holder or a private label holder. Az yc>@b,L CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. The website misrepresents it as NIOSH certified but is not NIOSH approved. However, note the misspelling of NIOSH on the front of the 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 and Health (NIOSH) and that met eligibility criteria as described in the EUA. INSAFE is not a NIOSH approval holder or a private label holder. Guangzhou Bofeite Safety Protective Supplies Co., Ltd. UHEALTH MEDICAL (BEIJING) PROTECTIVE PRODUCTS CO., LTD. Jingzhou Strong Sciences & Technology Development Co.,ltd. 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. KN95 Protective Face Mask GB2626 Standard (5-Pack) - The Home Depot 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9480V (FFP2). The site is secure. E\^ CO1_`b UjFDVB^uO|cYSNG["@&V21kS|g|m)]1o=HgB$+6_eYkPf]. (12/3/2020), This is an example of a misrepresentation of a NIOSH approval. Parents will love that the mask has a 95 percent filtration rate and can be reused up to 50 times. If you suspect you have a counterfeit or misrepresented respirator, contact NIOSH at ppeconcerns@cdc.gov. Models sold by EPC, including but not limited to, PT-N95F-01, PT-N95C-02, and PT-N95CS-02 are NOT NIOSH approved. Chengde Technology Co., Ltd. is not a NIOSH approval holder or a private label assignee. Statements made alongside an image of the Arun KN95 Folding Face Mask that it is "listed on FDA EUA for Non-NIOSH Devices" and representing compliance with "GB2626-2006" [https://www . 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); View examples of counterfeit or misrepresented respirators below. If you notice that a mask is wet or dirty, or if its damaged for example, if any part of it is worn away, or if the straps are broken or stretched you should throw it out, she said. (2/18/2021), Raxwell Industrial Technology Co., Ltd. is misusing NIOSH test information regarding Raxwell model RX9501 KN95 Face Masks. (2/18/2021), This is an example of a misrepresentation of a NIOSH Approved product. 1. Check if the manufacturer is listed here. (12/21/2020), This is an example of a misrepresentation of a NIOSH approval. As we mentioned above, KN95 masks are designed to meet a Chinese standard and theyre not regulated in the U.S. TC-84A-8125 is a valid NIOSH approval number. All NIOSH Approved respirators have a testing and certification (TC) approval number (e.g., TC 84A-XXXX). The masks come in six different sizes that range from XXS to XL. Dongguan AOXING is not a NIOSH approval holder or a private label assignee. Evolvetogethers KN95 masks come in a pack of five and are individually wrapped in what the company has said are biodegradable pouches. All information these cookies collect is aggregated and therefore anonymous. 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. The mask features double-welded head straps with an adjustable nose piece to provide a strong fit and seal against the wearers face. 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. Although they appear to be from NIOSH, these documents include alterations and false information. (12/1/2021), This is an example of a misrepresentation of a NIOSH approval. GUANGDONG GOLDEN LEAVES TECHNOLOGY DEVELOPMENT CO., LTD. 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. Additionally, Moaron incorrectly advertises that it is compatible with other NIOSH approved products. 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. These models have not been NIOSH approved since 2015. NIOSH also registered the certification marks N95, N99, N100, P95, R95, P100, PAPR100-N, PAPR100-P, HE, and NIOSH Approved with the USPTO. You can find a specific manufacturer by clicking on the first letter of their name on the index below. It has four protective layers, two headbands, and an adjustable nose bridge wire. When it comes to . A KN95 mask should not be damaged in any way, Packaging should never include false claims or logos from the FDA. KN95 Mask: 11 Things You Need to Know Before Buying 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. This is no longer a valid NIOSH approval number. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Powecom GB2626-AA KN95 Respirator Mask - FindTape.com Please refer to ouruser noticefor more information. 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. KN95 respiratory masks are masks that are regulated by the Chinese government under regulations GB2626-2006, GB262-2019, and GB19083-2010. (11/6/2019), This product is not NIOSH approved. Why We Like it: These fun, colorful masks feature a unique parrot design that makes them comfortable for kids to wear. 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. (9/9/2021), This is an example of a misrepresentation of a NIOSH approval. These are examples of counterfeit respirators. The 5-ply foldable KN95 mask has over 95% filtration . The CDC has said you should not double-mask while wearing a KN95 mask. (11/6/2019), NIOSH does not approve any type of respiratory protection for kids. efH3~#mM3IrNeYvbPF?$8}'|Oqq6_@Of|\CJq%Zq1. N95, KN95 or KF94? How to Find the Right Covid Mask - New York Times 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. You will be subject to the destination website's privacy policy when you follow the link. ~p.`QFFX%A._}Ba) .k[xx1qIbs6e)IOd#L) NDdUd}1|" Additionally, Good Mask Co. is misusing NIOSH test information. (8/25/2020), This is an example of a misrepresentation of a NIOSH approval. Experts have repeatedly stressed that masks help reduce the risk of viral transmission. The N95 respirator is the most common of the seven types of particulate filtering facepiece respirators. . (2/10/2020), There are no markings on the face of the respirator. 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. With all the different masks to choose from, many factors come into play when choosing a mask, such as when to wear one, the level of protection you want, fit, comfort, and cost-effectiveness. Pacifico Salud SAC is selling units using Suzhou Sanical Protection (SSP) approval number (TC-84A-6766) and label without SSPs permission. FDA Advisory No. 2020-2040 - Food and Drug Administration Its Worth Noting: The masks are not individually wrapped, so they may be hard to carry as spares when out and about. (11/6/2019), Images here are examples of counterfeit respirators and sold as if they are NIOSH approved. They also include an adjustable nose bridge and adjustable ear loops. Counterfeit Respirators | NPPTL | NIOSH | CDC A KN95 marked with a "GB" number ending in . The logo is wrong, there is no approval number (TC-84A-xxxx). ORp?[_{?"bS?%mWZ| b_KwlxaD= 4?m`" & >O> [;o By7cM/]7v` They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. G & F Products is not a NIOSH approval holder or a private label holder. hbbd``b`>$S8`9$@\F q b``$@ P Dongguan AOXING is marketing product using results from the assessment. This model has not been NIOSH approved since 2017. View official letters announcing NIOSH polices, notices for users (e.g., changes in a respirators approval status), and more. Greater than 95% filtration efficiency: to effectively protect respiratory health. hey cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. Yamada Safety First is not a NIOSH approval holder or a private label holder. NIOSH National Personal Protective Technology Laboratory. How to Spot Fake N95, KN95, and KF94 Masks, According to Experts This list is reviewed and updated weekly. Previously reported by Men's Health, the CDC is warning against several N95 respirators falsely claiming to be approved by NIOSH flooding the market, and therefore won't effectively protect you from COVID-19, especially the Omicron variant, spread. 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. (5/26/2021), This is an example of a misrepresentation of a NIOSH approval. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage: Strategies for Optimizing the Supply of N95 Respirators.