View the user notice announcing the rescission. 5-ply design: protects against airborne allergens and pollen greater than 0.3 microns in size. 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. Protection face mask, white, regular size (160 X 105 mm), Ear Loop KN95 face-masks filter at least 95% airborne particles that are non-oil based. efH3~#mM3IrNeYvbPF?$8}'|Oqq6_@Of|\CJq%Zq1. You can find a specific manufacturer by clicking on the first letter of their name on the index below. (11/5/2021), This is an example of a misrepresentation of a NIOSH approval. These models include, but are not limited to, models: Note that any SDH respirators with ear loops arenotNIOSH approved. G & F Products is not a NIOSH approval holder or a private label holder. Raxwell Industrial Technology Co., Ltd. is not a NIOSH approval holder or a private label holder. Using a fitter or brace is especially a good idea for people with facial hair, which can make it difficult to achieve a tight fit. hVQo6+|l2HJ@v,s#TI0jm$ww`4c Kingfa KN95 Face Mask 50 Pcs Disposable Respirator 5-Ply Layer | GB2626 U-SAFE does not have permission to use this certification mark because this is not a NIOSH Approved respirator. No, KN95 masks are not FDA-approved or NIOSH-approved. 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). He has also been a news editor for America Online and has contributed to the Associated Press and The Washington Post. With its unique parrot-beak design, the mask leaves space for your nose and mouth to easily breathe while still protecting you with its five layers of protection. 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. Huheta KN95 Face Mask, Individually Wrapped, Pack of 30, $33.99. Good Mask Co. markets the mask using results from the assessment. Xiantao Fushi Protective Products Co., Ltd. do not have permission to use this mark because this is not a NIOSH Approved respirator. However, the manufacturers website continues to state the ViraMask N99ESC is NIOSH certified. E\^ CO1_`b UjFDVB^uO|cYSNG["@&V21kS|g|m)]1o=HgB$+6_eYkPf]. 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. 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. 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 . They work together to block out more than 95 percent of particles. Why We Like It: These masks can be sent back to the company when youre done using them and the company will recycle them. KN95 masks are the Chinese equivalent of an N95 respirator in the U.S. A Chinese governing body similar to the U.S. National Institute for Occupational Safety and Health sets the standard for KN95 masks in China. With a 95 percent filtration rate, N95 masks reduce the wearer's exposure to particles including small particle aerosols and large droplets. Additionally, Health Protective is misusing NIOSH test information. The CDC has provided a visual aid for NIOSH-approved N95 respirators. You can follow her on Twitter and Instagram at @taylynharmon. These models have not been NIOSH approved since 2015. 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. It later ended the EUA because NIOSH-approved respirators were no longer in short supply. Parents will love that the mask has a 95 percent filtration rate and can be reused up to 50 times. This model has not been NIOSH approved since 2017. Zelbuck 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. The table below includes a list of non-NIOSH-approved disposable FFRs that were authorized under this Umbrella EUA for emergency use in healthcare settings by HCP when used in accordance with CDC recommendations. A respirator labeled as a KN95 respirator is expected to conform to China's GB2626 standard. If so, it will void the NIOSH approval. (3/5/2020), The Guangzhou Weini Technology & Development Co., Ltd. (GWT) respirator with model number K320 is not NIOSH approved. Pairon Solutions LLC - 616392 - 08/09/2021 | FDA Get answers to commonly asked questions about NIOSH Approved respirators and counterfeits. KN95 Mask: 11 Things You Need to Know Before Buying Why We Like it: The unique design makes the mask comfortable to wear for long periods of time (like on a flight). The use of this website means that you accept the confidentiality regulations and the conditions of service. Keep in mind face masks come in all different shapes and sizes. Results from NIOSH's testing are provided at: https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html. Select readers can get 20% off Evolvetogether's masks now through Mar. 'C;M5erf!~s-+8M9c$POJeb/m|:jdf&HI,r|R'{71W | Thank you for taking the time to confirm your preferences. SOUND is not a NIOSH approval holder or a private label holder. They are available in black and white, as well as multiple colors, all of which come in a pack of 10. These masks also feature an adjustable nose bridge. This content is imported from Tiktok. 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. Only manufacturers who are NIOSH approval holders may use these registered certification marks in accordance with applicable laws. The company references NPPTL testing claims , using an image of the test setup 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); Filtech Face Mask Model F860, F862, F890V, F891V, F890, F861. 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). Summaries of FDA's reissuances of this EUA follow. Why We Like it: This KN95 mask is lightweight and comfortable, plus it comes in multiple colors. 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. VIDAs N95 masks are NIOSH- and FDA-approved and are environmentally friendly. 5-pack: of disposable KN95 masks. (4/21/2021), EPC Product, LLC is misrepresenting product manufactured by their company as a NIOSH Approved respirator. Guangzhou Nan Qi Xing Non-Woven Co., Ltd. Huizhou Green Communication Equipment Manufacturing Co., Ltd. Jinhua Jiadaifu Medical Supplies Co., Ltd. Zhengzhou Ruipu Medical Technology Co. Ltd, Zhongkang Protective Equipment Technology (Guangzhou) Co., Ltd. Jiangsu Jiaao Medical Technology Co., Ltd. Liaoning Dalian Jieying Energy Saving Environmental Protection Technology Development Co., Ltd. Hunan Kangweining Medical Devices Co., Ltd. Chongqing China Nano Technology Co., Ltd. JIANGSU HOMCAN MEDICAL TECHNOLOGY CO. LTD, ZIGONG WEIKANG MEDICAL EQUIPMENT CO., LTD, Guangdong GangRong Medical Technology Co., Ltd. Guangdong Winsun Personal Care Products Co., Ltd. Guangzhou Carrot Mall Network Technologies Co., Ltd. Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd, Donghua Siecom Communication Technology Co.,Ltd, ZHEJIANG SHUNFA SAFETY TECHNOLOGY CO., LTD. JiangSu EverSmart Nano Technology Co., Ltd. Guangdong Seyouse Technology and Culture CO,.LTD. Greater than 95% filtration efficiency: to effectively protect respiratory health. Here, a cheat sheet of the different levels of protection offered by different masks and respirators: If youre wondering how to navigate the process of buying KN95 respirators, we talked to medical experts about who will benefit most by using them, when to wear them and how to shop for them. Adobe d '$''''$25552;;;;;;;;;; Cookies collect information about your preferences and your devices and are used to make the site work as you expect it to, to understand how you interact with the site, and to show advertisements that are targeted to your interests. Despite not being regulated, there are ways for these brands and their manufacturers to increase their trustworthiness, like FDA registration or inclusion in the FDAs now-defunct emergency use authorization (EUA), which it passed in 2020 to help medical workers choose KN95 masks. hb```f``zAXX&ACl`PxA>Qq L[c{nZ`_ M2K<2]i@`fUU @h$l8pP]%W%W'9@h$,!aN$T[$Tqs.l At this time, NIOSH has not approved respirators that use ear loops without the use of an approved fastener. If so, it will void the NIOSH approval. Yamada brand masks, including models 5241 and 8242, are not NIOSH approved. (3/12/2020), This is an example of a misrepresentation of the NIOSH approval. Its Worth Noting: Sizes may run larger than the measurements indicated on the website. 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. You should not wear international respirators with exhalation valves or vents, either, according to the CDC this guidance applies to all masks. The product package indicates it meets Chinese standard GB 2626-2006 and submitted to NIOSH under an International Respirator Assessment request. 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. The maximum and minimum filter efficiency was 99.00% and 98.31%, respectively. Additionally, Raxwell Industrial Technology Co., Ltd. is misrepresenting Raxwell model RX9501P N95 as a NIOSH Approved respirator. If you click on links we provide, we may receive compensation. (4/9/2020), This is an example of a counterfeit respirator. Each has six layers and an adjustable nose bridge. 17 with code SELECT20. List of NIOSH Approved Filtering Facepiece Respirators. Face masks, particularly high-filtration N95s and KN95s, were once a hot commodity during the pandemic. Nor does NIOSH approve any other respiratory protective device solely certified to international standards. Emergency Use Authorizations for Medical Devices, Recalls, Market Withdrawals and Safety Alerts, Emergency Use Authorizations for Medical Devices, Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices, Monkeypox (mpox) Emergency Use Authorizations for Medical Devices, Revoked EUAs for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators, Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China, Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment, Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities, Historical Information about Device Emergency Use Authorizations, Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China, Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs), Umbrella EUA: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China, Non-NIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China EUA FAQs, Respirator Models Previously Removed from Appendix A, Strategies for Optimizing the Supply of N95 Respirators, https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html, Umbrella EUA Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators, 9001, 9002, 9501, 9501+, 9501V+, 9502, 9502+, 9502V+, 9505+, 9541, 9541V, 9542, 9542V, 9552, 9552V, AOK Tooling Ltd. (aka Shenzhonghai Medical), 20130040, 20130045A, 20180021, 20130038, 20190019, 910, 20190029. #$%&'()*23456789:CDEFGHIJRTUVWXYZbcdefghijrstuvwxyz ? Vogmaskis not a NIOSH approval holder. The ultra-lightweight mask also provides comfort that helps wearers breathe easier, even while running and exercising. Powecom GB2626-AA KN95 Respirator Mask - FindTape.com They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. Additionally, Moaron incorrectly advertises that it is compatible with other NIOSH approved products. Surgical N95 respirators approved under the MOU do not require FDAs 510(k) clearance. The masks have an adjustable nose bridge, and you can purchase as few as 10 masks, which come individually wrapped. KN95 Face Mask | GB2626-2006 Standard | Mask By Whizley ORp?[_{?"bS?%mWZ| b_KwlxaD= 4?m`" & >O> [;o By7cM/]7v` Dongguan AOXING is marketing product using results from the assessment. The counterfeit respirator uses Shanghai Dasheng Health Products Manufacture Co. Ltds NIOSH approval number, TC 84A-4335, without their permission. They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. Experts we interviewed recommend you review your masks after receiving them and before wearing them with the following in mind: Additionally, Anne Miller, executive director of Project N95, a nonprofit that helps people source personal protective equipment and medical supplies, suggested shoppers review lab testing documents that clearly illustrate how well a mask acts as a filter. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Experts and the CDC recommend wearing a mask that covers your mouth and nose while fitting under your chin. Cookies used to make website functionality more relevant to you. (10/07/19), This is an example of two counterfeit respirators. These KN95 masks were featured on the FDAs EUA list. Use of face masks designated KN95 - Safety alert - HSE For more information, view the NIOSH Conformity Assessment Letter to Manufacturers, NIOSH CA 2022-1041R1. (7/24/2020), NIOSH received notice of websites selling and misrepresenting SAS model 8617A as NIOSH approved under TC-84A-4276. Additionally, KN95 masks will have GB2626 printed on them with 2006 or 2019 listed. To learn more about how to identify a NIOSH Approved FFR, check out the fact sheet and graphic below. This MOU granted NIOSH the authority to approve surgical N95 filtering facepiece respirators. However, the CDC said it continues to recommend that people wear masks in indoor public transportation settings, despite being unable to enforce any rules. The strong but pliable nose wire allows this mask to contour to the face for a snug fit. How to tell if your N95 Respirator is NIOSH Approved (2021) 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. (10/23/2019), This is anexample of misrepresentation of the NIOSH-approval. (2/18/2021), This is an example of a misrepresentation of a NIOSH Approved product. On March 24, 2021, the FDA revised this EUA to authorize for emergency use only those respirators listed in the EUA's Exhibit 1 as of the date of this reissuance. Osprey is not a NIOSH approval holder or a private label assignee. Why We Like it: These disposable surgical masks are made in the United States. Before sharing sensitive information, make sure you're on a federal government site. Pangolin and Pangocare do not have permission to use this mark because this is not a NIOSH Approved respirator. Centers for Disease Control and Prevention. Fits securely over face: to prevent shifting during movement. From fit to comfort and everything in between, we tried KN95 masks that aligned with what medical experts and the CDC recommend looking for.
