… NPPTL makes no representation as to the authenticity of the samples received and assessed. The assessment is destructive and the samples cannot be reused. Also check the CDC Assessment Results for Not NIOSH-approved respirators for filtration performance. NIOSH has been informed that many legitimate manufacturers in China have been counterfeited. How to read a Flow - Volume display Learn how to recognize obstructive & restrictive patterns, hesitating starts, coughs, and other causes of poor subject effort that may invalidate test results. NPPTL makes no representation as to the authenticity of the samples received and assessed. These assessments were developed as an assessment of the filter efficiency for those respirators represented as certified by an international certification authority, other than NIOSH, to support the availability of respiratory protection to US healthcare workers and other workers due to the respirator shortage associated with COVID-19. Mezorrison Health Science & Technology (shenzhen) Co., Ltd. National High-Tech Enterprise Chengde Technology Co., Ltd. Ningbo & Mental Smart & Technology Co., LTD. Ningbo Green Health Science & Technology Co., Ltd. Ningbo Laida Automotive Technology Co., Ltd. Ningbo Yixin Intelligent Technology Co., Ltd. Ningbo YiXin Intelligentized Science and Technology Co. Ltd. Ningjin County Dunwei Labor Insurance Products Co., Ltd. Ningyang Liyuan Filter Material Products Co., Ltd. PUTIAN JINLI.LAISI CLOTHING & ACCESSORIES CO., LTD. Qidong Shenfeng Medical Equipment Co, Ltd. Qingdao Hainuo Biological Engineering Co., Ltd. Qingdao Maysheng Medical Devices Co., Ltd. Qingdao Maysheng Medical Devices Co., Ltd. Qingdao Orphila Medical Technology Co., Ltd. Quanzhou Xinan Medical Technology Co., Ltd. Raxwell Industrial Technology (Shanghai) Co., Ltd. Rizhao Sanqi Medical & Health Articles Co., Ltd. KN95 Non-Powered Air-Purifying Particulate Respirator. Filtering Efficiency Excerpted from International Assessment Results – Not NIOSH-approved as of September 1, 2020 Manufacturer. The International Respirator Assessment is a point-of-use assessment and is not to be used by manufacturers, distributers, suppliers, or importers attempting to sell products in the United States. International Assessment Results – Not NIOSH-approved. Tianjin Benmo Medical Equipment Co., Ltd. Tongcheng Chengfeng Protective Equipment Co., Ltd. Tongcheng Jieli Labor Protection Products Co., Ltd. Trust Loyalty & Glory Epoch Network Technology Co., Ltd. USA (not NIOSH-approved but claimed NIOSH TEB-APR-STP-0059). Therefore, the authenticity of the claims, that the product meets a particular international standard, cannot be validated. Assessment results can be viewed on the NIOSH website. Our data shows that the majority of products being submitted for evaluation, are not on the FDA EUAs. These results are not to be used by manufacturers, distributors, suppliers, and importers to make claims about their products and/or to influence purchasers. FDA has the guidance. Guangzhou Huashan Biotechnology Co., Ltd. Guangzhou Powecom Labor Insurance Supplies Co., Ltd. 9502 Particle filtering half mask (non-medical), Guangzhou Sunrise Sanitary Articles Co., Ltd. Guangzhou Tianyi Zhongliang Biotechnology Group Co., Ltd. Guangzhou Yun Rui Shengshi Protection Technology Co., Ltd. Guizhou Bocai Medical Equipment Co., Ltd. Hangzhou Biopharmaceutical National High-tech Industrial Base Investment Management Co., Ltd. Hefei Kadi Biological Pharmaceutical Co., Ltd. Honeywell Safety Products (Shanghai) Co., Ltd. Huizhou Green Communication Equipment Manufacturing Co., Ltd. Huizhou Zhongna Medical Technology Co., Ltd, Anysound KN95 Self-Priming Filter & Anti-Particle Respirator. • Assessment of Filter Penetration Performance for Non-NIOSH Approved Respirators – NPPTL Assessment to Support the COVID-19 Response (10 samples) Modified TEB … • This assessment is not a confirmation that it conforms with any or all of its specifications in accordance with its certification mark. CDC’s Factors to Consider When Planning to Purchase Respirators from Another Country. CDC's NPPTL Respirator International Assessments Filtration Results for not NIOSH-approved to determine if filtration levels are adequate for your use. While the above-listed product classifications have similar performance requirements to NIOSH-approved devices, CDC does not have knowledge about sustained manufacturer quality system and product quality control for these products. Examples of new techniques will be presented. 3M 9502+ GB2626 98.56 98.24 . This assessment was developed as an assessment of the filter efficiency for those respirator’s represented as certified by a foreign certification authority, other than NIOSH, to support the availability of respiratory protection to US healthcare workers due to the respirator shortage associated with COVID-19. Xiamen Lixia Medical Technology Co., Ltd. Xiamen Luan’an Protective Equipment Co., Ltd. Eversafe KN95 Self-Priming Filter Respirator. NIOSH-approved N95s typically have head bands. NIOSH urges purchasers of masks and respirators that may have questions about the authenticity of these products to contact directly the manufacturers and others in the supply chain as needed to verify that they are obtaining legitimate products. While filter efficiency shows how well the filter media performs, users must ensure a proper fit is achieved. Wenzhou Younuo Protective Product Co., Ltd. Wuchuan Yuexing Labor Protection Products Co., Ltd. RespiPro Carbon FFP2 Nanofiber Respirator. Shandong Daddy’s Choice Health Science and Technology Co., Ltd. Shandong Haidike Medical Products Co., Ltd. Shandong Minghang Nonwoven Products Co., Ltd. Shandong Shengquan New Materials Co., Ltd. Biomass Graphene Particulate Respirator (C-Shaped), Biomass Graphene Particulate Respirator (Willow leaf-Shaped). Location: This program is usually held at a local hotel, located between … The NIOSH technique of a 10% change rarely works in real life. The ear loop design can make it difficult to ensure that a proper fit is achieved. • This assessment was not a part of the NIOSH approval program. During the COVID-19 pandemic, the demand for NIOSH-approved N95 filter … NPPTL initiated these assessments to provide users and purchasers of respirators brought into the US to quantify the product’s filtration efficiency in advance of or before purchases are made from distributors. ... Counterfeit respirators are products that are falsely marketed and sold as being NIOSH-approved and may not be capable of providing appropriate respiratory protection to workers. Before proceeding to the form below, please check the International Respirator Assessment Results to see if we have already assessed the product you have. It needs to be understood that product test results meeting the requirements of a single STP, TEB-APR-STP-0059 pdf icon, does not imply the respirator is NIOSH approved. The results posted to the NIOSH website identify the manufacturer of the respirator, the model number or product line, the international standard the product claims to meet, and filtration efficiency. Check for inconsistent markings. 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. This course uses a combination of lectures and hands-on practice … As part of its standard respirator approval process for NIOSH-approved respirators, NPPTL conducts a comprehensive quality assurance … NIOSH-Approved Particulate Filtering Facepiece Respirators. Thirty respirators were submitted for evaluation. The National Institute for Occupational Safety and Health today released a report summarizing the particulate filtration efficiency of non-NIOSH-approved N95 respirators made in other countries and authorized for emergency use during the COVID-19 public health emergency.. NPPTL makes no representation as to the authenticity of the samples received and assessed. Guangdong Kaper Protection Technology Co., Ltd. Guangdong Mingxiang Medical Instrument Co., Ltd. Guangdong Nuokang Medical Technology Co., Ltd. Guangdong Shantou Haimeisi Clothing Co., LTD. Guangdong Zhizhen Biological Medicine Co., Ltd. KN95 Three-Dimensional Protective Respirator, KN95 Three-Dimensional Protective Respirator (disposable respirator). Respirator Assessments to Support the COVID-19 Response, International Assessment Results . This guidance provides Crisis Alternate Strategies that includes the option: “Use of respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators.” The other countries listed in the guidance and their associated product classifications are shown below. NPPTL points out that most of the products on the list have an ear loop design. Total inward leakage is defined as the combination of contaminated air that … As part of its standard respirator approval process for NIOSH-approved respirators, NIOSH conducts a … over suppliers and distributors of respirators certified by other national or international parties. The test articles submitted by the sponsor conform to this criterion for airflow resistance. At the onset of the COVID-19 pandemic, international respirator products, mostly from China, were being imported into the United States. If assessment of multiple models of respirators is being requested, this form should be completed for each model. Explore AIHA. Do your safety and health job better … Our experienced staff works closely with NIOSH, … Changshu City Hengyun Nonwoven Products Co., Ltd. Chongqing China Nano Technology Co., Ltd. Dongguan Angel Leather Technology Co. Ltd. Dongguan HuaGang Communication Technology Co., Ltd. Dongguan Liangji Technology Development Co., Ltd. Dongguan Oukangda Medical Technology Co., Ltd. Dongguan Sengtor Plastics Products Co., Ltd. Foldable Protective Earloop Mask Non-Medical, Dongguan Tian Ren He Yi intelligent Co., LTD. Dongguan Weicon Medical Equipment Technology Co., Ltd. Dongguan Wei Sheng Medical Technology Co., Ltd. Dongguan Xianda Medical Equipment Co., Ltd. Dongyang Qingdou Household Commodity Co., Ltd. Elizabeth (Guangzhou) Medical Technology Co., Ltd. Fengxian Ratone Medical Technology Co., Ltd. Foshan Daylead Newcon Technology Co., Ltd. Foshan Nanhai Weijian Sanbang Protective Equipment Technology Co., Ltd. Foshan Nanhai Weijian SanBang Protective Products Technology Co., Ltd. Fujian Jimei Household Products Co., Ltd. Fujian Little Forest Technology Co., Ltd. Fujian Sunkinetic Smart Technology Co., Ltd. N95 Particulate Respirator (non-medical mask). NIOSH also does not have knowledge about the product’s handling and exposures after leaving its manufacturer’s control. Jiangsu Newborn Medical Technology Co., Ltd. Jiangsu Weibang Medical Products Co., Ltd. Jiangsu Weichuangli New Materials Co., Ltd. Jiangxi Guoyou Medical Technology Co., LTD. Jiangxi Guoyou Medical Technology Co., Ltd. Jiangxi Yifengyuan Biological Engineering CO., Ltd. Jiaxing Furuibang New Material Technology Co., Ltd. Jinhua Jiadaifu Medical Supplies Co., Ltd. Jinhua Jinchuang Labor Protection Tools Factory. * See examples in the CDC Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies, Centers for Disease Control and Prevention. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. You will be subject to the destination website's privacy policy when you follow the link. CDC's NPPTL Respirator International Assessments Filtration Results for not NIOSH-approved to determine if filtration levels are adequate for your use. Only particulate filter efficiency will be assessed as inhalation and exhalation resistance and fit testing are not a part of this assessment. No … Students who successfully complete the USF/COPH NIOSH-approved spirometry training course will receive a certificate from Dr. Thomas Truncale. None of these reviews were conducted during this limited assessment. For each model listed, ten respirators were submitted for evaluation. for Your Health Care Facility. You will be subject to the destination website's privacy policy when you follow the link. ICS has continually demonstrated competence to perform testing to the 75+ NIOSH test methods listed on its ISO/IEC scope of accreditation issued by the American Association for Laboratory Accreditation. The agency conducted 105 assessments of 102 models made by 87 manufacturers at the … The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Respirator Assessment Results Considered as Counterfeit and/or Misuse of Company Name, Centers for Disease Control and Prevention. Please see the International Respirator Assessment Planpdf icon for additional information. No certificates of approval were provided with the samples received. AIHA is here to help you and your loved ones stay healthy at work and in your community. The test articles submitted by the sponsor conform to this NIOSH criterion for airflow resistance. International Respirator Assessment Requests originating from any of these email domains will NOT be considered. NPPTL created the International Respirator Assessment Request to assess the filter efficiency performance of these products. Gaomi City Hancheng Personal Protective Products Co., Ltd. Gaomi Chenheng Labor Protection Supplies Co., Ltd. Guangdong Aixida Pharmaceutical Co., Ltd. Guangdong Energy Fortress Pharmaceutical Co., Ltd. Guangdong For You Essentials Manufacturing Co., Ltd. Guangdong Golden Leaves Technology Development Co., Ltd. Guangdong Jiangmen Huayue Industrial Co. Ltd. Three-Dimensional Protective Respirator (disposable respirator). All the resources you ever thought you’d need to advance your career, one click away. Model Number/Product Line Standard Filtration efficiency NIOSH Test Report Maximum Minimum. The results confirm that the NIOSH certification offers good protection according to the normative criteria. NIOSH has the authority to test and approve respiratory protection devices used by workers, under 42 CFR part 84. The results of these tests are for the sample tested and may or may not be representative of a larger lot or population of similar respirators. performance assessments on some of the international FFRs available in the United States that are not NIOSH approved, and posts the results on its website.17 The postings include the name of the manufacturer, the model number, the international standard used to manufacture the respirator, the maximum and minimum filtration efficiency (%) results and a link to a copy of the complete test … Saving Lives, Protecting People, The National Personal Protective Technology Laboratory (NPPTL), Strategies for Optimizing the Supply of N95 Respirators, CDC Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies, 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 Respirator Assessment Request, Beyond Shelf Life/Stockpiled Assessment Results, International Respirator Assessment Request, Decontaminated Respirator Assessment Request, Non-NIOSH approved Innovative Filtering Facepiece Respirator Assessment Request, Decontaminated International Respirators Assessment Request, 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. Shandong Sino Medical Equipment Co., Ltd. Shandong Tricol Marine Biological Technology Co., Ltd. Shandong Zhushi Pharmaceutical Group Co., Ltd. Shanghai Dasheng Health Products Manufacture Co., Ltd. Shanghai Gangkai Purifying Products Co., Ltd. Shanghai Huaxiang Woolen Dressing Co., Ltd. Shanghai Kindly Medical Instruments Automation Research Center Co., Ltd. Shenzhen Dingwei Optical Technology Co., Ltd. Shenzhen FITTOP Health Technology Co., Ltd. Shenzhen Guidong Information Consulting Co., Ltd. Shenzhen Jiameilantai Industrial Co., Ltd. Shenzhen Kawang Network Technology Co., Ltd. Shenzhen Mingjiang Medical Supplies Development Co., Ltd. Shenzhen Sanai Medical Devices Group Co., Ltd. SHENZHEN XIANDA INFORMATION TECHNOLOGY CO., LTD. Shenzhen Zhanhuwei Medical Supplies Co., Ltd. Shenzhen Zhongyue Health Technology Co., Ltd. Suzhou Jinruida Protective Equipment Co, Inc. Suzhou Letian Protective Products Co., Ltd. TF-003 Effective Particles Filtering Mask. All submissions must include the respirator manufacturer, the model number/name, and verification of the standard that was used. Furthermore, limited assessment of ear loop designs, indicate difficulty achieving a proper fit. These assessments are not a part of the NIOSH respirator approval process and will in no way lead to or preclude NIOSH approval through the official approval process. CEL Data last Updated: February 2, 2021 11:15 AM Page last reviewed: Decemer 17, 2020 Page last updated: December 17, 2020 Content source: National Institute for Occupational Safety and Health (NIOSH) Liaoning Baosheng Medical Technology Co., Ltd. Liaoning Shengjingtang Biotechnology Co., Ltd. Makrite Industries, Inc. (Dongguan Sure-on Industrial Ltd.), Makrite Industries, Inc. (Makrite Hubei Industrial Co., Ltd.), Makrite Industries, Inc. (Dongguan Sure-On Plastic & Fiber Products Co., Ltd.), Makrite Industries, Inc. (Dongguan Sure-On Industrial Ltd.). The FDA Emergency Use Authorizationsexternal icon provide guidance on the use of these products. To protect American workplaces, requests from federal and state agencies, employers, and healthcare systems will be accepted. The samples were tested using a modified version of NIOSH Standard Test Procedure (STP) TEB-APR-STP-0059. Indicators of Fraudulent or Counterfeit Vendors/Suppliers The Indicators of Fraudulent 3M Personal Protective Equipment Liaison Information Report, prepared by the FBI and 3M, highlights the following tactics commonly used by criminals: Demand up-front payment of all or a … In such cases, NIOSH has no way of verifying which products are counterfeit and which are authentic. • This assessment was not a part of the NIOSH approval program. The results of any filter penetration test can only be used to provide a check of the product’s filter efficiency. Become an IH Hero. The International Respirator Assessment requires that 10 samples be sent. Further, no certificates of approval were provided with the samples. Guangzhou Harley Commodity Company Limited, through correspondence with NIOSH, has indicated that th eir products have been counterfeited. Assessment results confirm that some of these products have poor filter efficiency and are of poor quality. As part of its standard respirator approval process for NIOSH-approved respirators, NIOSH conducts a comprehensive quality assurance review of the quality process and manufacturing site. A number of manufacturers have also informed NIOSH that they did not produce the products associated with their name. International Assessment Filtration Results – Not NIOSH-approved Considerations for Selecting Respirators. 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. This was certainly a record year for NIOSH … Any submission missing this information will not be assessed. Guangdong Nafei Industrial Holding Co., Ltd. Guangzhou Kangbang Medical Equipment Co., Ltd. Guangzhou Kangling Medical Supplies Co., Ltd. Shenzhen Hangsen Star Technology Co., Ltd. Examples include emails with domains such as @gmail.com, @yahoo.com, @aol.com, @hotnet.net, @vip.126.com, or @qq.com. The Letter of Authorization states that FDA has concluded that certain imported disposable FFRs that are not NIOSH-approved may still be appropriate to protect the public health or safety if they are used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during the shortages of FFRs as a result of the … The laboratory evaluated filtration performance of more than 8,500 respirators during the COVID-19 response, resulting in 550 reports informing the use of respirators that were 1) conforming to international … The CDC NPPTL has also released the International Assessment Results—not NIOSH—approved respirators. Public Resources. NIOSH also does not have knowledge about the product’s handling and exposures after leaving its manufacturer’s control. Therefore, validation of the claims that the product meets a particular international standard cannot be made. The results also include a NIOSH test report. The ‘KN95’ types present pressure drops which correspond to the … Pre-certification test data is required by NIOSH as part of their approval process for respiratory protective equipment. Some products with legitimate manufacturer names, showing poor filter penetration results (<95%), are counterfeit products. NPPTL has recently received new information from Stakeholders across the United States regarding products from China claiming to meet GB2626 and EN149. The data show a high disparity between different FFRs purchased by healthcare establishments, and between those that are NIOSH-approved and those that are not NIOSH-approved.