International . 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. 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. The results of any filter penetration test can only be used to provide a check of the product’s filter efficiency. 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. Become an IH Hero. You will be subject to the destination website's privacy policy when you follow the link. Find Help Here . International Assessment Results – Not NIOSH-approved NPPTL has completed International Assessments for the products listed below. The FDA said it is taking this public health action … Students who successfully complete the USF/COPH NIOSH-approved spirometry training course will receive a certificate from Dr. Thomas Truncale. For each model listed, ten respirators were submitted for evaluation. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. International Respirator Assessment Requests originating from any of these email domains will NOT be considered. NPPTL has completed International Assessments for the products listed below. On February 29, 2020, CDC published guidance Strategies for Optimizing the Supply of N95 Respirators. Therefore, the authenticity of the claims, that the product meets a particular international standard, cannot be validated. The FDA Emergency Use Authorizationsexternal icon provide guidance on the use of these products. 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. Thirty respirators were submitted for evaluation. Only particulate filter efficiency was assessed. In such cases, NIOSH has no way of verifying which products are counterfeit and which are authentic. 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. Any submission missing this information will not be assessed. Only particulate filter efficiency will be assessed as inhalation and exhalation resistance and fit testing are not a part of this assessment. The agency conducted 105 assessments of 102 models made by 87 manufacturers at the … This NIOSH-approved spirometry training course (approval #010) deals with all aspects of spirometry testing. 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. 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. 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. International Assessment Results – Not NIOSH-approved. for Your Health Care Facility. CDC twenty four seven. Do your safety and health job better … 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 is not responsible for Section 508 compliance (accessibility) on other federal or private website. COVID-19 Response International Assessment Results - Not NIOSH - Approved. NIOSH-Approved Particulate Filtering Facepiece Respirators. The ‘KN95’ types present pressure drops which correspond to the … AIHA is here to help you and your loved ones stay healthy at work and in your community. To protect American workplaces, requests from federal and state agencies, employers, and healthcare systems will be accepted. Please see the International Respirator Assessment Planpdf icon for additional information. Further, no certificates of approval were provided with the samples. The CDC NPPTL has also released the International Assessment Results—not NIOSH—approved respirators. Some products with legitimate manufacturer names, showing poor filter penetration results (<95%), are counterfeit products. Examples of new techniques will be presented. Assessment results confirm that some of these products have poor filter efficiency and are of poor quality. The results also include a NIOSH test report. NPPTL has completed International Assessments for the products listed below. Counterfeit Respirators / Misrepresentation of NIOSH-Approval. Guangdong Nafei Industrial Holding Co., Ltd. Guangzhou Kangbang Medical Equipment Co., Ltd. Guangzhou Kangling Medical Supplies Co., Ltd. Shenzhen Hangsen Star Technology Co., Ltd. NIOSH also does not have knowledge about the product’s handling and exposures after leaving its manufacturer’s control. Resources and Membership. Furthermore, limited assessment of ear loop designs, indicate difficulty achieving a proper fit. 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 … Wenzhou Younuo Protective Product Co., Ltd. Wuchuan Yuexing Labor Protection Products Co., Ltd. RespiPro Carbon FFP2 Nanofiber Respirator. This was certainly a record year for NIOSH … 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. During the COVID-19 pandemic, the demand for NIOSH-approved N95 filter … 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. Due to heightened concerns over counterfeiting, NPPTL will require review and validation of emails lacking recognizable company or organizational domains. Therefore, validation of the claims that the product meets a particular international standard cannot be made. Exceptions will be considered for requests made for Federal and State government agencies. This course uses a combination of lectures and hands-on practice … The ear loop design can make it difficult to ensure that a proper fit is achieved. One special aspect of this course is the high quality of individual instruction consisting of three (3) days. Respirator Assessments to Support the COVID-19 Response, International Assessment Results . 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. 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. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. The results of any filter penetration test can only be used to provide a check of the product’s filter efficiency. No … • This assessment is not a confirmation that it conforms with any or all of its specifications in accordance with its certification mark. Explore AIHA. over suppliers and distributors of respirators certified by other national or international parties. … All the resources you ever thought you’d need to advance your career, one click away. 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 NIOSH technique of a 10% change rarely works in real life. 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. Inspect the respirator and/or its packaging for the required labeling, as seen in the image above. Most of these products have an ear loop design. The results confirm that the NIOSH certification offers good protection according to the normative criteria. NIOSH also does not have knowledge about the product’s handling and exposures after leaving its manufacturer’s control. NIOSH-Approved N95 Particulate Filtering Facepiece Respirators – 3M Suppliers List. As part of its standard respirator approval process for NIOSH-approved respirators, NIOSH conducts a … • This assessment was not a part of the NIOSH approval program. 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. 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). 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. Filtering Efficiency Excerpted from International Assessment Results – Not NIOSH-approved as of September 1, 2020 Manufacturer. At the onset of the COVID-19 pandemic, international respirator products, mostly from China, were being imported into the United States. 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). NPPTL has recently received new information from Stakeholders across the United States regarding products from China claiming to meet GB2626 and EN149. Jining Jianda Medical Device Technology Co., Ltd. Kaiping Yuanbo Daily Necessities, Co., Ltd. Self-Breathing Filtration Particle-Preventive Respirator. 3M 9502+ GB2626 98.56 98.24 . The assessment is destructive and the samples cannot be reused. NIOSH-approved N95s typically have head bands. The test articles submitted by the sponsor conform to this NIOSH criterion for airflow resistance. NPPTL initiated these assessments to … While filter efficiency shows how well the filter media performs, users must ensure a proper fit is achieved. No certificates of approval were provided with the samples received. 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. 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). 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 … 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 … 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. Public Resources. There are many other requirements that must be met to achieve a NIOSH approval. 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. Guangzhou Powecom Labor Insurance Supplies Co., Ltd. … CDC's NPPTL Respirator International Assessments Filtration Results for not NIOSH-approved to determine if filtration levels are adequate for your use. Xiamen Lixia Medical Technology Co., Ltd. Xiamen Luan’an Protective Equipment Co., Ltd. Eversafe KN95 Self-Priming Filter Respirator. The test articles submitted by the sponsor conform to this criterion for airflow resistance. International Assessment Results – Not NIOSH-approved NPPTL has completed International Assessments for the products listed below. NPPTL makes no representation as to the authenticity of the samples received and assessed. 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) 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. 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. 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. None of these reviews were conducted during this limited assessment. The most important marking to verify NIOSH … CDC twenty four seven. The International Respirator Assessment requires that 10 samples be sent. If assessment of multiple models of respirators is being requested, this form should be completed for each model. Pre-certification test data is required by NIOSH as part of their approval process for respiratory protective equipment. Also check the CDC Assessment Results for Not NIOSH-approved respirators for filtration performance. 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. 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 samples were tested using the modified version of NIOSH Standard Test … 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. Check for inconsistent markings. Why not think of a mission-focused STEM career? ... 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. Professionals. NPPTL makes no representation as to the authenticity of the samples received and assessed. NIOSH has been informed that many legitimate manufacturers in China have been counterfeited. 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.
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