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). 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. (4/9/2020), Any respirators sold as Maskin are no longer NIOSH approved. However,. If so, it will void the NIOSH approval. Some brands publish these online, while others may send them to you if you ask. The use of this website means that you accept the confidentiality regulations and the conditions of service. 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 Happy Masks come in different sizes however the adjustable nose wire and ear straps help ensure a perfect fit for various face shapes. Filtech Face Mask Model F860, F862, F890V, F891V, F890, F861. They help us to know which pages are the most and least popular and see how visitors move around the site. KN95 masks are manufactured to offer 95% protection from particulate matter, like the N95 mask. Xiantao Fushi Protective Products Co., Ltd. do not have permission to use this mark because this is not a NIOSH Approved respirator. 1961 0 obj <>/Filter/FlateDecode/ID[<4934D10D090E404999D820306277A183>]/Index[1953 19]/Info 1952 0 R/Length 60/Prev 989616/Root 1954 0 R/Size 1972/Type/XRef/W[1 2 1]>>stream Its Worth Noting: These masks are on the smaller side, so they may not be a good choice for people with large faces. PROTECTIVE FACE MASK Expiry Date: 2 years Standard :GB2626-2006 (Non-Medical Device) Manufacturer:SILVERFOX CORPORATION LIMITED Manufacturing Address: No. Sobmex respirators are NOT NIOSH approved. E\^ CO1_`b UjFDVB^uO|cYSNG["@&V21kS|g|m)]1o=HgB$+6_eYkPf]. (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. They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. Surgical N95 respirators approved under the MOU do not require FDAs 510(k) clearance. Stella Clavecillo, D.O. FDA Advisory No. | How to wear a KN95 mask. 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. Its Worth Noting: This mask may not be a great option for people with small faces. This counterfeit respirator, NT-V2 Nano Bi-Directional respirator, is advertised as a NIOSH approved, using a NIOSH approval number. (2/4/2021), This is an example of a misrepresentation of a NIOSH approved product. 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. Notice on HHS Ownership of Respirator Certification Marks. Xiantao Fushi Protective Products Co., Ltd. is not a NIOSH approval holder or a private label holder. If you click on links we provide, we may receive compensation. g1>Es}( 4 Pz:GH This is no longer a valid NIOSH approval number. How do you know which masks are legit, and even more so where to get one? 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. Additionally, an abbreviated approval label is on the filtering facepiece respirator (FFR) itself or straps. Filtering facepiece respirator has ear loops instead of headbands. The site is secure. 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. With a 95 percent filtration rate, N95 masks reduce the wearer's exposure to particles including small particle aerosols and large droplets. 'p^c8EN%VR[44g EtglF Example of correct exterior markings on a NIOSH Approved filtering facepiece respirator. View the user notice announcing the rescission. Any misuse of these marks is at least a direct violation of applicable trademark laws. The mask has five layers with 2 filtration layers that filter more than 98 percent of all airborne particles. Check if the manufacturer is listed here. Learn more about how to identify NIOSH Approved respirators and counterfeits. Proper KN95s will be given a two- to three-year expiration date, says Passas. Zhengzhou Ruipu Medical Technology Co., Ltd. advertises the product using results from the assessment. Pure&Safe is not a NIOSH approval holder or a private label assignee. (1/4/2019). From fit to comfort and everything in between, we tried KN95 masks that aligned with what medical experts and the CDC recommend looking for. The counterfeit respirator uses Shanghai Dasheng Health Products Manufacture Co. Ltds NIOSH approval number, TC 84A-4335, without their permission. Powecoms KN95 masks were featured on the FDAs EUA list. However, you dont have to toss a KN95 mask after a single use. Neither Pangolin nor Pangocare is a NIOSH approval holder or a private label holder. DUKAL is not a NIOSH approval holder or a private label holder. (9/9/2021), Moaron is NOT a NIOSH approval holder, and they are misrepresenting product as meeting NIOSH approval. Surgical masks also dont fit as snugly as N95 or KN95 masks, so their protection is not as strong. (11/5/2021), Dongguan AOXING is misusing NIOSH test information for its KN95 Protective Mask model AX-KF95. Surgical N95 respirators approved under the MOU do not require FDA's 510 (k) clearance. 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. Guangdong Languan Medical Biotechnology Co., Ltd. Zhejiang Dongmeng Medical Equipment Co., LTD, Changshu Dayi Health Protection Articles Co., Ltd, FOSHAN FLOCON MEDICAL EQUIPMENTS CO., LTD, QUANZHOU LIGAO PROTECTIVE PRODUCT MANUFACTURER CO.,LTD, Zhuhai HealthPro Medical Equipment Co., Ltd. Fujian Yifa Healthcare Products Co., Ltd. Dongguan Rysam Medical Equipment Manufacturing Co. The product listing claims the filter meets NIOSH P100-series. NIOSH only approves whole respirator configurations, not individual components. SOUND is not a NIOSH approval holder or a private label holder. 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 ear loop of this mask is made of a highly stretchable soft material that is latex-free. They issued a notice to alert customers of a product potentially manufactured without the permission of Makrite. They cannot use the results to influence purchasers or make claims that the product meets NIOSH approval requirements. The product package indicates it meets Chinese standard GB 2626-2006 and submitted to NIOSH under an International Respirator Assessment request. (11/5/2021), This is an example of a misrepresentation of a NIOSH approval. When comparing different types of masks, properly fitted respirators provide the highest level of protection, including N95s and KN95s, according to the CDC. ZHEJIANG LUYAO ELECTRONICS TECHNOLOGY CO., LTD. Chongqing Zisun (Zaisheng) Technology Corp., Ltd. Shandong Haidike Medical Products Co., Ltd. Read honest and unbiased product reviews from . The strong ear loop wont break as easily as other disposable face masks. No, KN95 masks are not FDA-approved or NIOSH-approved. View official letters announcing NIOSH polices, notices for users (e.g., changes in a respirators approval status), and more. These models include, but are not limited to, models: Note that any SDH respirators with ear loops arenotNIOSH approved. For more information, view, Private label of Foss Manufacturing Company. The masks have an adjustable nose bridge, and you can purchase as few as 10 masks, which come individually wrapped. 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); On June 6, 2020, the FDA further revised the Scope of Authorization of this EUA, including, among other changes, further revision to the eligibility criteria to provide additional specificity regarding the jurisdictions eligible for review and to remove decontaminated respirators from the scope of authorized products such that authorized respirator models listed in Appendix A are not authorized if they are decontaminated. Powecom's KN95 masks were featured on the FDA's EUA list. 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. Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V. If youre wondering which type of face covering to choose, respirators among them KN95 masks and N95 masks offer more protection than cloth masks, according to the CDC, which stops short of directly recommending one mask over another. 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. . If you dont have an N95 or KN95 mask, a surgical mask is the next best option. The fastener connects the loops behind the head. Pacifico Salud SAC is selling units using Suzhou Sanical Protection (SSP) approval number (TC-84A-6766) and label without SSPs permission. Dongguan AOXING is not a NIOSH approval holder or a private label assignee. Additionally, Good Mask Co. is misusing NIOSH test information. 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. All information these cookies collect is aggregated and therefore anonymous. You can also purchase individually packaged KN95s. Look for the KN95 standard printed on the mask In 2020, the FDA granted emergency-use authorization (EUA) for some KN95 masks due to N95 masks supply being scarce. NIOSH successfully registered the NIOSH stylized logos with the U.S. Patent and Trademark Office (USPTO). The NIOSH stylized logo is a registered certification mark owned by HHS. hb```f``zAXX&ACl`PxA>Qq L[c{nZ`_ M2K<2]i@`fUU @h$l8pP]%W%W'9@h$,!aN$T[$Tqs.l 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). On March 28, 2020, FDA revised this EUA to authorize the use of certain authorized respirators that have been decontaminated pursuant to the terms and conditions of an authorized decontamination system. These respirators were authorized for use by healthcare personnel in healthcare settings in accordance with the CDC's recommendations. The CDC also has a list of NIOSH-approved manufacturers to ensure your mask is certified for your protection. To confirm that the KN95 you're buying is legitimate, make sure the manufacturer is listed on the FDA's Emergency Use Authorization list. These masks also feature an adjustable nose bridge. We also take steps to ensure that all expert advice and recommendations are made independently and with no undisclosed financial conflicts of interest. (3/26/2021), SS Paper Convertors is misrepresenting protective masks as NIOSH approved. Guangzhou Bofeite Safety Protective Supplies Co., Ltd. UHEALTH MEDICAL (BEIJING) PROTECTIVE PRODUCTS CO., LTD. Jingzhou Strong Sciences & Technology Development Co.,ltd. 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. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage: Strategies for Optimizing the Supply of N95 Respirators.
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