NIOSH-approved N95s typically have head bands. 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. CDC twenty four seven. Our experienced staff works closely with NIOSH, … Filtering Efficiency Excerpted from International Assessment Results – Not NIOSH-approved as of September 1, 2020 Manufacturer. FDA has the guidance. International Assessment Results – Not NIOSH-approved NPPTL has completed International Assessments for the products listed below. NIOSH also does not have knowledge about the product’s handling and exposures after leaving its manufacturer’s control. NPPTL makes no representation as to the authenticity of the samples received and assessed. Total inward leakage is defined as the combination of contaminated air that … Only particulate filter efficiency will be assessed as inhalation and exhalation resistance and fit testing are not a part of this assessment. 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. 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. NIOSH-Approved N95 Particulate Filtering Facepiece Respirators – 3M Suppliers List. 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. 3M 9502+ GB2626 98.56 98.24 . 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. Why not think of a mission-focused STEM career? No conclusions can be made regarding equivalency to N95 products that are NIOSH approved. Professionals. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. NPPTL is working closely with the FDA to align Emergency Use Authorizations to communicate the point of use testing results. 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. OSHA requires that respirators used in the workplace be NIOSH approved, and further requires that workers be individually fit tested as part of the respirator selection process. CDC's NPPTL Respirator International Assessments Filtration Results for not NIOSH-approved to determine if filtration levels are adequate for your use. International Assessment Filtration Results – Not NIOSH-approved Considerations for Selecting Respirators. In such cases, NIOSH has no way of verifying which products are counterfeit and which are authentic. Exceptions will be considered for requests made for Federal and State government agencies. The FDA Emergency Use Authorizationsexternal icon provide guidance on the use of these products. International Respirator Assessment Requests originating from any of these email domains will NOT be considered. ... 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. Students who successfully complete the USF/COPH NIOSH-approved spirometry training course will receive a certificate from Dr. Thomas Truncale. 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. Inspect the respirator and/or its packaging for the required labeling, as seen in the image above. One special aspect of this course is the high quality of individual instruction consisting of three (3) days. Requestor must also provide information where the product was purchased/obtained. NPPTL has completed International Assessments for the products listed below. • This assessment is not a confirmation that it conforms with any or all of its specifications in accordance with its certification mark. NPPTL has completed International Assessments for the products listed below. Respirator Assessment Results Considered as Counterfeit and/or Misuse of Company Name, Centers for Disease Control and Prevention. CDC's NPPTL Respirator International Assessments Filtration Results for not NIOSH-approved to determine if filtration levels are adequate for your use. Zhongshan Qiangou Protective Equipment Technology Co., Ltd. Zhongshan Siyuan Electric Appliance Co., Ltd. Zhongshan Zhongxin Medical Technology Co., Ltd. Beijing Ruishan Bozhong Medical Instrument Co., Ltd. Dongguan Leihuo Medical Equipment Co., Ltd. KN95 Foldable Particulate Protection Mask. The ear loop design can make it difficult to ensure that a proper fit is achieved. All submissions must include the respirator manufacturer, the model number/name, and verification of the standard that was used. During the COVID-19 pandemic, the demand for NIOSH-approved N95 filter … Xiamen Probtain Medical Technology Co., Ltd. Xiantao Xianghua Industry & Trade Co., LTD. Xiantao Zhong Yi Safety & Protection Products Co., Ltd. Yiwu Baibian Electronic Techology Co., Ltd. Yiwu Henghao Household Products Co., Ltd. Yufing (Guangdong) Lighting Technology Co., Ltd. ZhangJiaGang ShineYa Sanitary Products Co., Ltd. Zhangjiagang Zhiyi Medical Health Products Co., Ltd. Zhejiang Baiyi Intelligent Garment Co., Ltd. Zhejiang Beilan Protective Equipment Co., Ltd. Zhejiang Kanghao Medical Instruments Co., Ltd. Zhejiang Shengtai Baby Products Co., Ltd. Zhejiang Xingxin Medical Techology Co., Ltd. Zhengzhou Ruipu Medical Technology Co., Ltd. Zhengzhou Wanshenshan Healthcare PPE Co., Ltd. Zhongkang Protective Equipment Technology (Guangzhou) Co., Ltd. Zhongshan Cassiey Biotechnology Co., Ltd. N95 Masks + Particulate Protection Respirator, Zhongshan Dongfeng Huangshang Electronics Factory. NIOSH has the authority to test and approve respiratory protection devices used by workers, under 42 CFR part 84. 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). The test articles submitted by the sponsor conform to this criterion for airflow resistance. NPPTL points out that most of the products on the list have an ear loop design. 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 … NPPTL makes no representation as to the authenticity of the samples received and assessed. The NIOSH technique of a 10% change rarely works in real life. Therefore, validation of the claims that the product meets a particular international standard cannot be made. National Institute for Occupational Safety and Health (NIOSH)-approved respirators are required by the Occupational Safety and Health Administration (OSHA) when personal respiratory protection is used in US occupational settings. 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. Further, no certificates of approval were provided with the samples. NPPTL makes no representation as to the authenticity of the samples received and assessed. On February 29, 2020, CDC published guidance Strategies for Optimizing the Supply of N95 Respirators. Thirty respirators were submitted for evaluation. 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). 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. Guangzhou Harley Commodity Company Limited, through correspondence with NIOSH, has indicated that th eir products have been counterfeited. Our data shows that the majority of products being submitted for evaluation, are not on the FDA EUAs. Wenzhou Younuo Protective Product Co., Ltd. Wuchuan Yuexing Labor Protection Products Co., Ltd. RespiPro Carbon FFP2 Nanofiber Respirator. Explore AIHA. Model Number/Product Line Standard Filtration efficiency NIOSH Test Report Maximum Minimum. While filter efficiency shows how well the filter media performs, users must ensure a proper fit is achieved. Also check the CDC Assessment Results for Not NIOSH-approved respirators for filtration performance. 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 samples were tested using the modified version of NIOSH Standard Test … There are many other requirements that must be met to achieve a NIOSH approval. This assessment is 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. As part of its standard respirator approval process for NIOSH-approved respirators, NPPTL conducts a comprehensive quality assurance … CDC’s Factors to Consider When Planning to Purchase Respirators from Another Country. NIOSH has been informed that many legitimate manufacturers in China have been counterfeited. As part of its standard respirator approval process for NIOSH-approved respirators, NPPTL conducts a comprehensive quality assurance … The ‘KN95’ types present pressure drops which correspond to the … 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. NIOSH also does not have knowledge about the product’s handling and exposures after leaving its manufacturer’s control. 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 … 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). 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. The International Respirator Assessment requires that 10 samples be sent. Saving Lives, Protecting People, The National Personal Protective Technology Laboratory (NPPTL), 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. If assessment of multiple models of respirators is being requested, this form should be completed for each model. 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). The assessment is destructive and the samples cannot be reused. You will be subject to the destination website's privacy policy when you follow the link. This was certainly a record year for NIOSH … 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. 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). COVID-19 Response International Assessment Results - 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. This NIOSH-approved spirometry training course (approval #010) deals with all aspects of spirometry testing. Assessment results can be viewed on the NIOSH website. The results also include a NIOSH test report. • This assessment was not a part of the NIOSH approval program. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 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 … International . While the above-listed product classification has similar performance requirements to NIOSH-approved devices, NIOSH does not have knowledge about the sustained manufacturer quality system and product quality control for these products. The samples were tested using a modified version of NIOSH Standard Test Procedure (STP) TEB-APR-STP-0059. Most of these products have an ear loop design. Guangzhou Aomy Biomedical Technology Co., Ltd. Guangzhou Baoweikang (Powecom) Personal Protection Equipment Co., Ltd. Guangzhou Harley Commodity Company Limited. • This assessment is not a confirmation that it conforms with any or all of its specifications in accordance with its certification mark. No … To protect American workplaces, requests from federal and state agencies, employers, and healthcare systems will be accepted. 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. Examples of new techniques will be presented. * See examples in the CDC Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies, Centers for Disease Control and Prevention. Before proceeding to the form below, please check the International Respirator Assessment Results to see if we have already assessed the product you have. He will issue the certificate on the final day of the course. Notable parts of this effort include the first NIOSH-approved elastomeric half mask respirator without an exhalation valve and a new powered air purifying respirator. While the manufacturer listed in the table is shown as the manufacturer of the product evaluated, NIOSH has been informed that some of these are actually counterfeit products. Pre-certification test data is required by NIOSH as part of their approval process for respiratory protective equipment. International Assessment Results – Not NIOSH-approved NPPTL has completed International Assessments for the products listed below. The results of any filter penetration test can only be used to provide a check of the product’s filter efficiency. 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 … Examples include emails with domains such as @gmail.com, @yahoo.com, @aol.com, @hotnet.net, @vip.126.com, or @qq.com. • This assessment was not a part of the NIOSH approval program. over suppliers and distributors of respirators certified by other national or international parties. As part of its standard respirator approval process for NIOSH-approved respirators, NIOSH conducts a … CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. 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. Check for inconsistent markings. The test articles submitted by the sponsor conform to this NIOSH criterion for airflow resistance. The agency conducted 105 assessments of 102 models made by 87 manufacturers at the … All the resources you ever thought you’d need to advance your career, one click away. None of these reviews were conducted during this limited assessment. 2020-168.1 2020-176.1 2020-156.2. Public Resources. 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. Respirator Assessments to Support the COVID-19 Response, International Assessment Results . Due to heightened concerns over counterfeiting, NPPTL will require review and validation of emails lacking recognizable company or organizational domains. International Assessment Results – Not NIOSH-approved. Furthermore, limited assessment of ear loop designs, indicate difficulty achieving a proper fit. … Become an IH Hero. Only particulate filter efficiency was assessed. 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 … To protect American workplaces, requests from federal and state agencies, employers, and healthcare systems will be accepted. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. NPPTL created the International Respirator Assessment Request to assess the filter efficiency performance of these products. The FDA said it is taking this public health action … 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. “I encourage everyone to not just focus on the filtration efficiency numbers, but to really look at the reports,” Powers told webinar … CDC twenty four seven. All lectures are given by Dr. Roy McKay, who has taught this course for nearly three (3) decades. No certificates of approval were provided with the samples received. Xiamen Lixia Medical Technology Co., Ltd. Xiamen Luan’an Protective Equipment Co., Ltd. Eversafe KN95 Self-Priming Filter Respirator. 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. AIHA is here to help you and your loved ones stay healthy at work and in your community. Jining Jianda Medical Device Technology Co., Ltd. Kaiping Yuanbo Daily Necessities, Co., Ltd. Self-Breathing Filtration Particle-Preventive Respirator. Guangdong Nafei Industrial Holding Co., Ltd. Guangzhou Kangbang Medical Equipment Co., Ltd. Guangzhou Kangling Medical Supplies Co., Ltd. Shenzhen Hangsen Star Technology Co., Ltd. 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.). Resources and Membership. Guangzhou Powecom Labor Insurance Supplies Co., Ltd. … Please see the International Respirator Assessment Planpdf icon for additional information. NIOSH-approved N95s typically have head bands. 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. 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. The most important marking to verify NIOSH … A number of manufacturers have also informed NIOSH that they did not produce the products associated with their name.