For masks that appeared on the FDAs EUA, we got documentation from the. Before sharing sensitive information, make sure you're on a federal government site. Why We Like it: The unique design makes the mask comfortable to wear for long periods of time (like on a flight). Example of correct exterior markings on a NIOSH Approved filtering facepiece respirator. You can also purchase . If so, it will void the NIOSH approval. Huizhou Green Communication Equipment Manufacturing Co., Ltd. is not a NIOSH approval holder or a private label assignee. (4/9/2020), This is an example of a counterfeit respirator. Face masks, particularly high-filtration N95s and KN95s, were once a hot commodity during the pandemic. 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. Search for NIOSH Approved respirators. Parents will love that the mask has a 95 percent filtration rate and can be reused up to 50 times. GUANGDONG GOLDEN LEAVES TECHNOLOGY DEVELOPMENT CO., LTD. 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. 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). These respirators were authorized for use by healthcare personnel in healthcare settings in accordance with the CDC's recommendations. . NIOSH also provides a table of the surgical N95 respirators approved prior to the MOU. It later ended the EUA because NIOSH-approved respirators were no longer in short supply. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. KN95 GB2626-2006 Today we introduce our newest product, the KN95 Respirator Mask to the Chinese standard GB2626-2006. 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. Many shoppers have noted how well the mask can be molded to properly fit their faces. The NIOSH website states manufacturers, distributors, suppliers, and importers cannot usethese results to make claims about their products. To do so, it analyzes how many Covid-related hospital beds are in use, hospital admissions and the total number of new Covid cases in that area. A banged up or partially opened box is an obvious sign of damage or tampering. TC-84A-8125 is a valid NIOSH approval number. 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. The Best KN95 Face Masks on Amazon, According to Reviews - People Some of the masks below appeared on the FDAs EUA we note which ones. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. For all of the masks below, weve obtained associated lab tests regarding filtration. Cookies used to make website functionality more relevant to you. Web links in the table go to the NIOSH Approval Holders website. This information is inaccurate. (1/4/2019). 5-ply design: protects against airborne allergens and pollen greater than 0.3 microns in size. The CDC also has a list of NIOSH-approved manufacturers to ensure your mask is certified for your protection. The mask must be snug on your face while allowing you to breathe easily. They come in a pack of 40, are built with an adjustable nose clip, and come in colors like white, black and grey. Pasture Pharma did not manufacture this counterfeit respirator. Its Worth Noting: These masks are on the smaller side, so they may not be a good choice for people with large faces. 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. 5-pack: of disposable KN95 masks. 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. They work together to block out more than 95 percent of particles. The mask has five layers with 2 filtration layers that filter more than 98 percent of all airborne particles. N95 is a registered certification mark owned by HHS. Based on a comparison from 3M, it is reasonable to consider China KN95, AS/NZ P2, Korea 1st Class, and Japan DS FFRs as "equivalent" to US NIOSH N95 and European FFP2 respirators, for filtering non-oil-based particles . ####''',,, 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. 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. 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. COVID-19: International Respirator Purchase | CDC 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. The soft inner lining is designed for comfort and to keep your face cool and moisture free. INSAFE is not a NIOSH approval holder or a private label holder. To confirm that the KN95 youre buying is legitimate, make sure the manufacturer is listed on the FDA's Emergency Use Authorization list.
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