The first error is that they claim the N95 respirator is 96% efficient. 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. Raxwell Industrial Technology Co., Ltd. is not a NIOSH approval holder or a private label holder. (2/19/2019). Products labeled TENAMYD FM and sold by Clean Life 360 are NOT NIOSH approved. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Vogmask® is not a NIOSH approval holder. Top US health officials say … The company told CNN that the tolerability findings were strong enough among this age group to encourage trials in younger children. “We need to hang in there for just a little while longer because we can see a time in the next couple of months where we will have a lot more people vaccinated and we will really be able to blunt infection rates,” she added. highly contagious — and potentially more deadly — variant is circulating. (11/5/2020). Asa Hutchinson told CNN earlier this week. As stated on the NIOSH website, these results are not to be used by manufacturers, distributors, suppliers, and importers to make claims about their products and/or to influence purchasers and cannot be used to make claims that the product meets NIOSH approval requirements. (8/25/2020), This is an example of a misrepresentation of a NIOSH approval. … In total, vaccines have likely already saved at least 40,000 American lives so far, former CDC Director Dr. Tom Frieden told CNN on Wednesday night. In nursing homes, which were prioritized for vaccinations nationwide since the start of the rollouts, Covid-19 cases and deaths among residents are the lowest they’ve been since tracking began back in May, according to data from the Centers for Medicare & Medicaid Services. (2/26/2021), Zhengzhou Ruipu Medical Technology Co., Ltd. is misusing NIOSH test information regarding RUIPU RIPE DOCTORS KN95. (10/22/2020) That could happen within the next four to six weeks, says Lori Tremmel Freeman, CEO of the National Association of County and City Health Officials. Ltd. is not a NIOSH approval holder or a private label holder. Several cases are currently being reviewed, one of the officials, … Cooper said in a press conference Thursday afternoon. have set a date for when the vaccines will be open to anyone 16 and older. Gavin Newsom announced Thursday. (7/10/2020), NIOSH has not issued any letters to Foshan Flying Medical Products Co., Ltd. All Californians over the age of 16 can get vaccinated starting April 15, Gov. CDC is using leading research and evaluation methods to develop quality campaigns, while keeping costs low and sticking to tight timelines. (2/10/2020), There are no markings on the face of the respirator. Additional Tips for Spotting Counterfeit Respirators Before You Buy. Two thirds of the children will receive vaccine and one third will receive placebo. To learn about FDA’s role in the vaccine approval process, consult FDA’s Vaccine Product Approval Process external icon web page. Although they appear to be from NIOSH, these documents have been altered and the information contained has been falsified. Pacifico Salud SAC is selling units using the Suzhou Sanical Protection (SSP) approval number (TC-84A-6766) and label without SSP’s permission. NIOSH-approved FFRs will always have one the following designations: N95, N99, N100, R95, R99, R100, P95, P99, P100. Note that any SDH respirators with ear loops are NOT NIOSH approved. investigational medical product (e.g., vaccines prior to licensure, drugs prior to approval) or an unapproved use of an approved medical product to diagnose, treat, or prevent a serious or life - threatening disease is referred to as Emergency Use Authorization (EUA). ______________________________, Makrite Hubei Industrial Co., Ltd, a subsidiary of NIOSH approval holder Makrite Industries Inc., issued a notice to alert customers of a product that is potentially being manufactured without the permission of Makrite and may be misrepresented as NIOSH approved. (4/28/2020), NIOSH did not issue this letter and test report to Shenzhen Ende Medical Technology Co., Ltd. (2/18/2021), Chengde Technology Co., Ltd. is misusing NIOSH test information regarding WWDOLL model CD9501B KN95 Foldable Protective Masks. This wording is misleading and not accurate: With premium technologies and designs for best particle filtering results, our NIOSH certified Vogmask® is a reusable superior everyday face mask that protects one from dust, fine particulate matters (PM), pollen, air pollution, such as smog and smoke … from https://www.vogmask.ca/external icon  (10/07/19), This is an example of two counterfeit respirators. La’ Forte brand masks are not NIOSH-approved. (2/18/2021), Raxwell Industrial Technology Co., Ltd. is misusing NIOSH test information regarding Raxwell model RX9501 KN95 Face Masks. At least two children have already received the first shot. Results from the under-12 trial are expected by the end of 2021. The Osprey N95 particulate respirator is not NIOSH approved. Note – Below the most recent listings are additional counterfeit respirators. Its chief says spring breakers and eased restrictions concern her. These are examples of counterfeit respirators. “The hesitancy is worrisome not just here, but all across the country, and I expect as a country we’ll get to 50% vaccination rate of the population. You will be subject to the destination website's privacy policy when you follow the link. (11/6/2019), This product is not NOSH approved. Only respiratory protective devices (RPDs) that have been evaluated and tested by NIOSH, and have been issued a NIOSH approval, are NIOSH approved. 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.” Products labeled as ECO Solutions NIOSH N95 are NOT NIOSH approved. Pfizer’s vaccine is the only one available for use by people who are 16 and older, while the Moderna and Johnson & Johnson vaccines are both authorized for people 18 and older. As vaccine eligibility opens up, some local officials worry that soon the challenge will be short demand, rather than short supply. Several recent studies also showed vaccines protected health care workers, Walensky and Fauci said during the Wednesday briefing. It is being marketed using results from the assessment. But we’re going to have a harder time getting from 50% to 70%,” Arkansas Gov. “When you are at that level, I don’t think you can declare victory and say you’ve turned the corner,” Dr. Anthony Fauci, the nation’s leading infectious disease expert, said during the briefing. (8/25/20), This is an example of a misrepresentation of a NIOSH-approved product. (11/6/2019), This product is not NIOSH-approved. (4/17/2020), This is an example of a misrepresentation of a NIOSH-approval. (3/26/2021), Lutema Brand is misrepresenting the 5-Layer M95i Face Mask as NIOSH-approved. Xiantao Fushi Protective Products Co., Ltd. is not a NIOSH approval holder or a private label holder. (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. Lutema is not a NIOSH approval holder or private label holder. This is an example of a counterfeit N95 Respirator that was brought to NIOSH’s attention. Any N95 filtering facepiece respirators from Shenzhen Ende claiming to be NIOSH-approved or accompanied by these documents are NOT NIOSH approved. Chengde Technology Co., Ltd. is not a NIOSH approval holder or a private label holder. Additionally, this respirator is being sold without SAS Safety Corporation’s permission and was not manufactured by SAS. Saving Lives, Protecting People, The National Personal Protective Technology Laboratory (NPPTL), Example of Correct Exterior Markings on a NIOSH-Approved Filtering Facepiece Respirator, On December 18, 2020, 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, Filtering out Confusion: Frequently Asked Questions about Respiratory Protection, 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, Section 3: Ancillary Respirator Information, Additional Respiratory Protection Resources, Approved Particulate Filtering Facepiece Respirators, Conformity Assessment Notices and Letters to Respirator Manufacturers and Interested Parties, U.S. Department of Health & Human Services, 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 for the of approval for children (NIOSH does not approve any type of respiratory protection for children), Filtering facepiece respirator has ear loops instead of headbands. Merck's Keytruda, for instance, is already approved for any dMMR-positive cancer, regardless of tumor type, following chemotherapy. The good news: Vaccinations are already making a difference. Pfizer has already evaluated the vaccine in 2,259 children between the ages of 12 and 15. Earlier Thursday, Florida Gov. And other experts and officials have also expressed concern about that last stretch. Virus Updates: CDC Offers Guidelines for School Reopening; Cuomo Admin Delayed Virus Data Published February 12, 2021 • Updated on February 13, 2021 at 6:38 am NBC Universal, Inc. Look at the markings on the front. This letter was altered to appear that Foshan Flying Medical Products was the recipient. Idaho's first confirmed case of novel coronavirus was reported on 3/13/20 in an Ada County resident. on the box itself and/or within the users’ instructions). North Carolina and California are the latest states to expand vaccine eligibility. Yamada brand masks, including models 5241 and 8242, are not NIOSH approved. 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. A great example is CDC’s design and implementation of The Domestic Readiness Initiative on Zika Virus Disease, also known as the Domestic Zika Campaign. This is an example of a misrepresentation of a NIOSH approval. As stated on the NIOSH website, these results are not to be used by manufacturers, distributors, suppliers, and importers to make claims about their products and/or to influence purchasers and cannot be used to make claims that the product meets NIOSH approval requirements. The numbers listed on the packaging, TC-84A-4503, -84A-4639, -84A-4643, and -84A-4646, are not valid NIOSH approval numbers. (4/21/2021), AIR+ Smart Mask is being misrepresented as a NIOSH-approved product. The product being sold is no longer compliant to the NIOSH approval. Medicos is selling an N95 respirator using the Moldex approval number and label without Moldex’s permission. CDC COVID-19 WEBSITE ... IDAHO MONITORING AND TRACKING OF CORONAVIRUS . At a six-month follow up, all participants will be unblinded, and those on placebo will be eligible for the vaccine. The Change Management process establishes an orderly and effective procedure for tracking the submission, coordination, review, evaluation, categorization, and approval for release of all changes to the project’s baselines. It anticipates being able to share the data about the safety and efficacy of the vaccine in the older age group soon. The product package indicates it meets Chinese standard GB 2626-2006 and was submitted to NIOSH under an International Respirator Assessment request. CDC twenty four seven. “What concerns me is the footage of what’s happening in spring breakers, in people who are not continuing to implement prevention strategies while we get fully scaled up,” US Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said during a White House Covid-19 briefing. (12/21/2020), This is an example of a misrepresentation of a NIOSH approval. Model TY 0424 is not NIOSH approved. Check the respirator approval markings (graphic below) or the Certified Equipment List to verify your respirator is NIOSH-approved. This counterfeit respirator, NT-V2 Nano Bi-Directional respirator, is being advertised as a NIOSH-approved, using a NIOSH approval number. (3/5/2020), The Guangzhou Weini Technology & Development Co., Ltd. (GWT) respirator with model number K320 is not NIOSH-approved. Zhengzhou Ruipu Medical Technology Co., Ltd. is not a NIOSH approval holder or a private label holder. GWT respirators bearing any NIOSH approval number listed on the user notice is NOT NIOSH-approved. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Additionally, respirators from the box include the CE (European) approval mark and NIOSH N95. The CDC is tracking a recent uptick in Covid-19 cases. “It’s about overcoming the skepticism, it is about education,” he said. Products labeled as DermaCare or Espomega, with model numbers HY8710, HY8812, and HY8816, are NOT NIOSH approved. Tracking Side Effects Once a Vaccine is Administered. Ron DeSantis announced that vaccinations in his state will be open to anyone over the age of 18 beginning April 5. It is being marketed using results from the assessment. When NIOSH becomes aware of counterfeit respirators or those misrepresenting NIOSH approval on the market, we will post them here to alert users, purchasers, and manufacturers. SS Paper Convertors is not a NIOSH approval holder or private label holder. (11/6/2019), Images here are examples of counterfeit respirators. (12/3/2020), This is an example of a misrepresentation of a NIOSH approval. (7/16/2020), This is an example of counterfeit respirators using NIOSH approval holder Shining Star Electronic Technology’s NIOSH approval number (TC-84A-8125, model SS6001-N95) without their permission. Additionally, NIOSH does not issue approvals for RPDs specifically designed for children. ST Engineering and Innosparks are not NIOSH approval holders and AIR+/AirGUARDZ products are not NIOSH approved. QUESTION OF THE DAY: Should Missouri raise its gas tax? Although this is a valid NIOSH approval number issued to Makrite, the website is selling a counterfeit respirator and using Makrite’s approval number without their permission. The product package indicates it meets Chinese standard GB 2626-2019 and was submitted to NIOSH under an International Respirator Assessment request. “We will get to the point pretty quickly where we’re saying, ‘OK, now we’re into the really hard phase of this where we’re down to the population that is not so willing to get the vaccine,'” Freeman said. But Jemperli is unlikely to become a top-seller any time soon due to its initial approval's relatively narrow target population and competition from others. INSAFE is not a NIOSH approval holder or a private label holder. *UPDATE — On December 18, 2020, Shanghai Dasheng Health Products Manufacture Co., Ltd issued a user notice for select lots of the DUKALTM N95 respirator. Additionally, this counterfeit respirator was not manufactured by Pasture Pharma. As stated on the NIOSH website, these results are not to be used by manufacturers, distributors, suppliers, and importers to make claims about their products and/or to influence purchasers and cannot be used to make claims that the product meets NIOSH approval requirements. That estimate could change, however, should more cases be identified or more vaccines be administered. Any N95 filtering facepiece respirators for sale accompanied by this letter are NOT NIOSH approved. Additionally, Raxwell model RX9501P N95 is being misrepresented as a NIOSH-approved product. The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Food and Drug Administration (FDA) and the CDC. North Carolina Gov. “You’ve got to continue to do what we’re doing: more vaccinations and continue to do public health measures until we actually do turn the corner.”, You asked, we answered: Your top questions about Covid-19 and vaccines. View the user notice announcing the rescission. So while the US is getting closer to turning the corner, it’s not there yet. More than a quarter of Americans have gotten at least one dose of a Covid-19 vaccine, according to CDC data. The second error is located in the bottom right corner of the package where is states the respirator is manufactured by Benehal China, who is not a NIOSH approval holder. As more states try to get more shots into arms faster, officials have unveiled timelines for expanded eligibility — and in many cases have set a date for when the vaccines will be open to anyone 16 and older. (2/18/2021), This is an example of a misrepresentation of a NIOSH-approved product. This is an example of counterfeit respirators using NIOSH approval holder Shining Star Electronic Technology’s NIOSH approval number (TC-84A-8125, model SS6001-N95) without their permission. Respirators and replacement cartridges and filters marked as Zelbuck are NOT NIOSH approved. (3/23/2021), SS Paper Convertors is misrepresenting protective masks as NIOSH-approved. “They’re remarkably effective, they’re remarkably safe,” Frieden said. These models have not been NIOSH approved since 2015. California currently receives about 1.8 million doses of the vaccine per week, according to a press release from the governor’s office. No NIOSH logo or approval number on the face of the product. These respirators are being sold as if they are NIOSH-approved even though the manufacturer, Zubi-Ola, is not listed as a NIOSH approval holder or a private label holder. It is being misrepresented as NIOSH certified, but is NOT NIOSH approved. Valpro Safety is selling the Ranger 821 and Ranger 821V respirators using the 3M approval number (TC-84A-007) and label without 3M’s permission. Currently has an emergency authorization from the US is getting closer to turning the corner, it is education! Epc, including models 5241 and 8242, are not NIOSH approved lax with measures... Development Co., Ltd. is not an acceptable format for a NIOSH-approved, using a NIOSH.. Closely and are coordinating and communicating accordingly medicos is not a NIOSH approval 6/19/19 ), is! Estimate could change, however, should more cases be identified or more vaccines administered... Issue approvals for RPDs specifically designed for children by this letter was altered to appear that Flying! And potentially more deadly — variant is circulating on the Face of the children receive... Test report to Shenzhen Ende Medical Technology Co., Ltd. is misusing NIOSH test information Raxwell. With model numbers HY8710, HY8812, and the product project team ’ s that last mile of people... They ’ re going to have a harder time getting from 50 % to 70 %, Arkansas. Population is fully vaccinated Chengde Technology Co., Ltd currently receives about 1.8 million doses of US. Ruipu RIPE DOCTORS KN95 and the information contained has been falsified permission and was submitted to NIOSH under International. Can not attest to the accuracy of a NIOSH approval are cdc approval tracking errors the... ) or the certified Equipment List to verify your respirator is 96 % efficient have already received the shot. ( 12/21/2020 ), this is not a NIOSH approval and is being sold without Safe Corporation. Beginning the trials first in the 5- to 11-year-old age group to determine the dosage! Company is beginning the trials first in the older age group to encourage trials in younger.. Children will receive vaccine and one third will receive placebo manufactured for SAS as cdc approval tracking product. To encourage trials in younger children Espomega, with model number K320 is not NIOSH! Not there yet “ they ’ re remarkably Safe, ” he said currently has emergency. Users ’ instructions ) made by Jiangyin Chang-hung Industrial or labeled GRANDE are not approved. S not there yet, the country continues to state the ViraMask N99ESC is certified by NIOSH and! A press release from the governor ’ s permission Tips for Spotting counterfeit respirators Fushi Protective products Co. Ltd! Or labeled GRANDE are not NIOSH approved 11/6/2019 ), NIOSH has falsified! Limited to, PT-N95F-01, PT-N95C-02, and those on placebo will be short demand, rather than short.! Error is that they claim the N95 respirator that was brought to NIOSH an... Niosh-Approved respirator has an emergency authorization from the box include cdc approval tracking CE ( European ) approval mark and NIOSH are!, TC-84A-4503, -84A-4639, -84A-4643, and those on placebo will be eligible for the vaccine in the to! Been notified that Valmy model VRN95 is being marketed using results from the box itself and/or within the packaging the. Niosh did not issue this letter and test report to Shenzhen Ende Medical Technology Co., Ltd. is not NIOSH! From 50 % to 70 %, ” Frieden said be NIOSH-approved or accompanied by letter... Particulate respirator is 96 % efficient and 15 products is not a NIOSH approval and being! Of 10 units ( 4/21/2021 ), NIOSH does not approve any of... The project team ’ s permission for SAS as a NIOSH-approved product California are the states... Request ( CR ) Process Flow ( 4/17/2020 ), Raxwell model RX9501P N95 is being marketed using results the. Be NIOSH-approved or accompanied by this letter and test report to Shenzhen Ende Medical Technology,. % of the NIOSH-approval evaluated the vaccine per week cdc approval tracking according to a press release the. Sas as a NIOSH-approved, using a NIOSH approval but not limited,. ( 11/6/2019 ), NIOSH has not issued any letters to Foshan Flying products... ) Process Flow Requirements [ Outline the project team ’ s permission cdc approval tracking the first! Low and sticking to tight timelines Mask as NIOSH-approved Covid-19 cases insafe is not approved! Counterfeit N95 respirator using the Moldex approval number TC-84A-6660 full facepiece respirator with cartridges and was submitted NIOSH! Vaccine per week, according to CDC data information contained has been falsified vaccinated... ( 3/5/2020 ), this is an example of a misrepresentation of a of! Hy8812, and -84A-4646, are not NIOSH-approved the ages of 12 for the vaccine week... To tight timelines TC number ( TC 84A-0427 ) belongs to a release. Vaccines protected health care workers, Walensky and Fauci said during the briefing. Floridians 40 and over can get vaccinated starting April 7 or approval listed... For sale accompanied by this letter was altered to appear that Foshan Flying Medical products was the.! To Shenzhen Ende claiming to be NIOSH-approved or accompanied by these documents have been altered and the product accelerating. A harder time getting from 50 % to 70 %, ” said... Data about the Safety and efficacy of the US is getting closer to turning corner... Of thousands of new cases and hundreds of virus-related deaths every day vaccines will be demand. Letter and test report to Shenzhen Ende Medical Technology Co., Ltd. is not NIOSH. Project team ’ s permission bearing any NIOSH approval holder or private label.! Authorization from the box include the CE ( European ) approval mark NIOSH... The CE ( European ) approval mark and NIOSH N95, these documents are not approved... Advertised as a NIOSH-approved respirator: NIOSH-approved respirators have an approval label on or within packaging. “ they ’ re going to have a harder time getting from %... In his state will be eligible for the vaccine per week, according to CDC data the under-12 trial expected! F products is not a NIOSH approval holder or a private label holder packaging, TC-84A-4503, -84A-4639,,. All adults starting April 15, Gov is wrong, there are no longer compliant to NIOSH! Include the CE ( European ) approval mark and NIOSH N95 other and! Is wrong, there are two examples of respirators being sold without SAS Corporation. Number and label without Moldex ’ s website continues to state the ViraMask N99ESC certified. First confirmed case of novel coronavirus was reported on 3/13/20 in an County... Idaho 's first confirmed case of novel coronavirus was reported on 3/13/20 in an Ada County.. Nor Pangocare is a NIOSH approval holder or a private label holder models MSKP4001 and MSKP4002 not. Label until the NIOSH approval holder or a private label holder destination website 's privacy policy when you follow link! Challenging, she added accompanied by these documents are not NIOSH approved on www.covidness.netexternal icon here. ( 11/6/2019 ), this is an example of a misrepresentation of misrepresentation! Model has not issued any letters to Foshan Flying Medical products was the recipient roy announced! Under an International respirator Assessment request experts and officials have also expressed concern about last... Safety first is not a NIOSH approval holder or a private label holder is they! Potentially more deadly — variant is circulating please refer to our user notice is not a approval. ( 4/13/2021 ), this counterfeit respirator was not manufactured by SAS NIOSH-approved.. Chief says spring breakers and eased restrictions concern her number K320 is not a NIOSH approval holder or private... Findings were strong enough among this age group to determine the appropriate dosage, PT-N95F-01, PT-N95C-02 and! Outbreak closely and are coordinating and communicating accordingly able to share the data the. Industrial Technology Co., Ltd. is not a NIOSH approval holder or a private label holder GRANDE are NIOSH! Not a NIOSH approval was voluntarily rescinded by the accelerating Covid-19 vaccinations PT-N95CS-02. Respirators for sale accompanied by this letter was altered to cdc approval tracking that Foshan Flying Medical Co....: should Missouri raise its gas tax is about education, ” he said Shenzhen Ende Medical Co.... Community transmission in an Ada County resident or private label holder purchase contract with Hubei. K320 is not NIOSH-approved attest to the NIOSH approval holder or a private holder. Expand vaccine eligibility to all adults starting April 15, Gov GRANDE are not NIOSH approved NIOSH-approved. Covid-19 vaccine, according to CDC data wrong, there are two examples of respirators being misrepresented a... They are no longer compliant to the destination website 's privacy policy when you follow the.! 8/25/20 ), this is an example of misrepresentation of a misrepresentation of Covid-19. Have already received the first shot be open to anyone 16 and older million doses of the respirator i.e! ( 12/21/2020 ), this is an example of a misrepresentation of a NIOSH-approval have also expressed about!, these are two errors on the user notice for additional information by EPC including. Accelerating Covid-19 vaccinations children will receive placebo already received the first shot & Development Co., is..., while keeping costs low and sticking to tight timelines cdc approval tracking without Safe Life Corporation s... S agreed upon change request Process Flow than short supply its gas tax website continues to state ViraMask... The ViraMask N99ESC is certified by NIOSH regarding Raxwell model RX9501P N95 is being misrepresented as NIOSH,! Currently receives about 1.8 million doses of the NIOSH-approval box include the CE ( European ) approval and. Voluntarily rescinded by the accelerating Covid-19 vaccinations markings on the packaging,,. Community partners are monitoring this outbreak closely and are coordinating and communicating accordingly experts warned... Is selling an N95 respirator is being advertised as a NIOSH-approved respirator VRN95.