... 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. A number of manufacturers have also informed NIOSH that they did not produce the products associated with their name. Also check the CDC Assessment Results for Not NIOSH-approved respirators for filtration performance. If assessment of multiple models of respirators is being requested, this form should be completed for each model. 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) The ‘KN95’ types present pressure drops which correspond to the … 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. The agency conducted 105 assessments of 102 models made by 87 manufacturers at the … 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. NPPTL makes no representation as to the authenticity of the samples received and assessed. Hunan Royal Crown Medical Products Co., Ltd. Medical Protective Mask (Non-Sterile) – Foldable Type, Hunan YuanKang Biological Technology Co, Ltd, Hunan Youhong Medical Technology Co., Ltd. Jiangmen Huadizhiguang Lighting Co., Ltd. JT-KN95 Reusable and Sterilizable Nano-mask KN95. NPPTL created the International Respirator Assessment Request to assess the filter efficiency performance of these products. 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). 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 … Model Number/Product Line Standard Filtration efficiency NIOSH Test Report Maximum Minimum. The NIOSH technique of a 10% change rarely works in real life. While filter efficiency shows how well the filter media performs, users must ensure a proper fit is achieved. Xiamen Lixia Medical Technology Co., Ltd. Xiamen Luan’an Protective Equipment Co., Ltd. Eversafe KN95 Self-Priming Filter Respirator. All the resources you ever thought you’d need to advance your career, one click away. Therefore, the authenticity of the claims, that the product meets a particular international standard, cannot be validated. The samples were tested using the modified version of NIOSH Standard Test … 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. The samples were tested using a modified version of NIOSH Standard Test Procedure (STP) TEB-APR-STP-0059. 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. 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. CDC’s Factors to Consider When Planning to Purchase Respirators from Another Country. Some products with legitimate manufacturer names, showing poor filter penetration results (<95%), are counterfeit products. 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 … packaging and labeling indicate that it is a NIOSH-approved produc t, under approval number TC -84A-7228. NPPTL makes no representation as to the authenticity of the samples received and assessed. Inspect the respirator and/or its packaging for the required labeling, as seen in the image above. 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. International Assessment Results – Not NIOSH-approved NPPTL has completed International Assessments for the products listed below. for Your Health Care Facility. Wenzhou Younuo Protective Product Co., Ltd. Wuchuan Yuexing Labor Protection Products Co., Ltd. RespiPro Carbon FFP2 Nanofiber Respirator. Assessment results can be viewed on the NIOSH website. Requestor must also provide information where the product was purchased/obtained. 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. No conclusions can be made regarding equivalency to N95 products that are 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. over suppliers and distributors of respirators certified by other national or international parties. International Assessment Results – Not NIOSH-approved NPPTL has completed International Assessments for the products listed below. Public Resources. Resources and Membership. NPPTL has completed International Assessments for the products listed below. 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.. Further, no certificates of approval were provided with the samples. Most of these products have an ear loop design. To protect American workplaces, requests from federal and state agencies, employers, and healthcare systems will be accepted. Check for inconsistent markings. Any submission missing this information will not be assessed. The assessment is destructive and the samples cannot be reused. As part of its standard respirator approval process for NIOSH-approved respirators, NPPTL conducts a comprehensive quality assurance … • Assessment of Filter Penetration Performance for Non-NIOSH Approved Respirators – NPPTL Assessment to Support the COVID-19 Response (10 samples) Modified TEB … Only particulate filter efficiency will be assessed as inhalation and exhalation resistance and fit testing are not a part of this assessment. CDC's NPPTL Respirator International Assessments Filtration Results for not NIOSH-approved to determine if filtration levels are adequate for your use. The most important marking to verify 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. These results are not to be used by manufacturers, distributors, suppliers, and importers to make claims about their products and/or to influence purchasers. Anhui Baishidun Protective Equipment Co., Ltd. Anhui Changli Environmental Protection Technology Co., Ltd. Anhui Huabai Photoelectric Technology Co., Ltd. Anhui Jiabao Protective Equipments Co., Ltd. Anhui Kangweijia Labor Protection Articles Co., Ltd. Anhui Meihu Medical Supplies Technology Co., Ltd. Anhui Zhongke Duling Commercial Appliance Co., Ltd. Anshun Health & Medical Technology Co., Ltd. Baoji Taidakang Medical Technology Co., Ltd. Changning Lingjiakang Protective Products Factory. None of these reviews were conducted during this limited assessment. CDC's NPPTL Respirator International Assessments Filtration Results for not NIOSH-approved to determine if filtration levels are adequate for your use. 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. For each model listed, ten respirators were submitted for evaluation. Guangzhou Powecom Labor Insurance Supplies Co., Ltd. … 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. Pre-certification test data is required by NIOSH as part of their approval process for respiratory protective equipment. NPPTL has completed International Assessments for the products listed below. over suppliers and distributors of respirators certified by other national or international parties. NIOSH-Approved Particulate Filtering Facepiece Respirators. Students who successfully complete the USF/COPH NIOSH-approved spirometry training course will receive a certificate from Dr. Thomas Truncale. Our experienced staff works closely with NIOSH, … The results of any filter penetration test can only be used to provide a check of the product’s filter efficiency. As part of its standard respirator approval process for NIOSH-approved respirators, NIOSH conducts a … He will issue the certificate on the final day of the course. FDA has the guidance. CDC twenty four seven. • This assessment is not a confirmation that it conforms with any or all of its specifications in accordance with its certification mark. No … In such cases, NIOSH has no way of verifying which products are counterfeit and which are authentic. Guangdong Nafei Industrial Holding Co., Ltd. Guangzhou Kangbang Medical Equipment Co., Ltd. Guangzhou Kangling Medical Supplies Co., Ltd. Shenzhen Hangsen Star Technology Co., Ltd. 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). This was certainly a record year for NIOSH … NPPTL is working closely with the FDA to align Emergency Use Authorizations to communicate the point of use testing results. NPPTL initiated these assessments to … To protect American workplaces, requests from federal and state agencies, employers, and healthcare systems will be accepted. 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 … The results of any filter penetration test can only be used to provide a check of the product’s filter efficiency. 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. Respirator Assessments to Support the COVID-19 Response, International Assessment Results . 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 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. International Assessment Filtration Results – Not NIOSH-approved Considerations for Selecting Respirators. 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 results confirm that the NIOSH certification offers good protection according to the normative criteria. One special aspect of this course is the high quality of individual instruction consisting of three (3) days. Filtering Efficiency Excerpted from International Assessment Results – Not NIOSH-approved as of September 1, 2020 Manufacturer. 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. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. NPPTL has recently received new information from Stakeholders across the United States regarding products from China claiming to meet GB2626 and EN149. 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 test articles submitted by the sponsor conform to this NIOSH criterion for airflow resistance. As part of its standard respirator approval process for NIOSH-approved respirators, NPPTL conducts a comprehensive quality assurance … 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. NPPTL makes no representation as to the authenticity of the samples received and assessed. 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. “I encourage everyone to not just focus on the filtration efficiency numbers, but to really look at the reports,” Powers told webinar … Therefore, validation of the claims that the product meets a particular international standard cannot be made. NIOSH-approved N95s typically have head bands. 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. 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.). Become an IH Hero. Jining Jianda Medical Device Technology Co., Ltd. Kaiping Yuanbo Daily Necessities, Co., Ltd. Self-Breathing Filtration Particle-Preventive Respirator. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. On February 29, 2020, CDC published guidance Strategies for Optimizing the Supply of N95 Respirators. COVID-19 Response International Assessment Results - Not NIOSH - Approved. 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. 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.