医械创新资讯
本文摘译自FDA 2020年5月7日
以下为详文
美国食品药品监督管理局（FDA）担心，根据美国国家职业安全与健康研究所（NIOSH）------美国疾病控制与预防中心（CDC）的国家个人防护技术实验室（NPPTL）（以下称为NIOSH测试）进行的额外过滤性能测试，部分来自中国的过滤式防护口罩（以下称：防护口罩）可能无法为接触COVID-19的医护人员，提供一致性和充分性的呼吸保护。因此，FDA修订并重新发布了2020年4月3日的EUA，如下所述。
2020年5月7日，FDA重新发布了中国制造的非NIOSH批准的一次性过滤式防护口罩的紧急使用授权（EUA），修订其中的一条适用条款------防护口罩的授权标准以制造商或进口商提交给FDA的检测评审报告为依据，该报告来自认可独立测试实验室-----据此，也从附录A中删除了根据该标准授权的防护口罩，无论它们是通过还是未通过NIOSH测试1。FDA之所以采取这种行动，是因为许多此类防护口罩在NIOSH进行测试时，均未能证明其最低颗粒过滤效率达到95％。
从EUA附录A中删除的防护口罩，且不符合其标注性能标准的（如下所列），不再具有资格；也不再被批准在美国销售或分销。如果根据《口罩总则EUA》满足了某些其他标准，它们还有机会重新贴上“口罩”的标签并获得授权。其他相关信息，请参阅FDA关于口罩的实施政策，如在《2020年4月冠状病毒疾病（COVID-19）突发公共卫生事件期间口罩及防护口罩的实施政策（修订版）》中的指导意见所述。
在重新发布的《紧急使用授权》中，符合其他资格标准的非NIOSH批准的防护口罩，FDA授权依然不变，可以在COVID-19大流行期间使用，且继续在附录A中列出。
注意事项
使用清单中这些防护口罩的医疗卫生机构应该审阅下列注意事项。该事项专门针对防护口罩，旨在实现非常紧密地贴合面部并过滤空气中的颗粒物。这些注意事项不适用于外科口罩，或宽松型口罩，它们可以在医护人员的口鼻和周围环境中的潜在污染物之间产生一道物理屏障。
▲ 不再出现在附录A中的防护口罩，可能在提供95％的最低颗粒过滤效率方面不可靠。请参阅《NIOSH评估网页》，以确定中国生产的非NIOSH批准的防护口罩是否经过检测，并审查检测结果。
▲ 迄今为止，从附录A删除的产品中，有60多个产品未能在NIOSH进行的检测中证明最低颗粒过滤效率为95％：
▲ NIOSH将定期更新其测试结果列表。以下为5月8日前103个中国防护口罩PFE(颗粒物过滤效率）测试结果清单
| 生产厂 | 型号规格 | 采纳标准 |
PFE （max) |
PFE （min) |
| Shanghai Dasheng Health Products Manufacture Co., Ltd. | DTC3B-1 | GB2626 | 99.92 | 99.83 |
| Shanghai Dasheng Health Products Manufacture Co., Ltd. | DTC3B | USA (claimed, 42 CFR 84) | 99.76 | 99.67 |
| Anhui Hongqiaosi Hometextile Co., Ltd. | KN95 Disposable Protective Face Mask | UNKNOWN | 99.8 | 99.64 |
| Shanghai Dasheng Health Products Manufacture Co., Ltd. | DTC3X | USA (claimed, 42 CFR 84) | 99.95 | 99.58 |
| Shanghai Dasheng Health Products Manufacture Co., Ltd. | DTC3X | USA (claimed, 42 CFR 84) | 99.84 | 99.45 |
| Shanghai Dasheng Health Products Manufacture Co., Ltd. | DTC3X (Sample Group 3 of 3) | USA (claimed, 42 CFR 84) | 99.76 | 99.34 |
| Xiamen Lixia Medical Technology Co., Ltd. | Lixia Medical Respirator | GB2626 | 99.96 | 99.31 |
| Shanghai Dasheng Health Products Manufacture Co., Ltd. | DTC3X (Sample Group 2 of 3) | USA (claimed, 42 CFR 84) | 99.63 | 99.31 |
| Qingdao Maysheng Medical Devices Co., Ltd | KN95 Protective Mask(Self Suction Filter Respirator FFP2) | GB2626 | 99.59 | 99.3 |
| Guangzhou Baoweikang (Powecom) Personal Protection Equipment Co., Ltd. | KN95 Protective Mask | GB2626 | 99.4 | 99.21 |
| Guangzhou Harley Commodity Co., Ltd. | L-103V KN95 | GB2626 | 99.49 | 99.02 |
| Te Yin | TY0929 FFP2 NR | EN149 | 99.7 | 98.89 |
| Shenzhen Kawang Network Technology Co., Ltd. | FFP3 | EN149 | 99.17 | 98.77 |
| Jiande Chaomei Daily Chemicals Co. Ltd. | Jan-05 | GB2626 | 99.19 | 98.73 |
| Anhui Jinling Plastics Company Limited | Protective Mask | EN149 | 99.66 | 98.67 |
| Zhandjiagang Meijie Commodity Co., Ltd | MJ-N02A (Particulate Respirator) | GB2626 | 99.47 | 98.55 |
| Jiangmen Huayue Industrial Co., Ltd. | HY9501 Folding Mask – KN95 | GB2626 | 99.55 | 98.48 |
| Honeywell Safety Products (Shanghai) Co., Ltd. | H801 Particulate Respirator | GB2626 | 99.32 | 98.4 |
| Shanghai Dasheng Health Products Manufacture Co., Ltd. | DTC3X (Sample Group 1 of 3) | USA (claimed, 42 CFR 84) | 99.66 | 98.32 |
| Gaomi City Hancheng Personal Protective Products Co., Ltd. | Baokangjie 9001 | GB2626 | 99.15 | 98.19 |
| UNKNOWN | UNKNOWN | GB2626 | 99.6 | 98.14 |
| Shanghai Gangkai Purifying Products Co., Ltd. | 8012 | GB2626 | 99.13 | 98.11 |
| Qingdao Hainuo Bioengineering Co., Ltd. | Hynaut KN95 Protective Face Mask | GB2626 | 98.37 | 97.98 |
| Zhangjiagang Zhiyi Medical Materials Co. | Self-Priming Filter Respirator KN95 | GB19083 | 99.26 | 97.93 |
| Guangdong Medical Technology Co., Ltd. | KN95 Stereo Protective Mask | EN149 | 99.18 | 97.91 |
| Suzhou Jinruida Protective Equipment Co, Inc. | KN95 Three Dimensional Respirator | GB2626 | 99.31 | 97.87 |
| Jiande Chaomei Daily Chemicals Co., Ltd. | CM 9527 | GB19083 | 99.29 | 97.87 |
| Laianzhi | KLT01 | GB2626 | 99.68 | 97.83 |
| Jiande Chaomei Daily Chemicals Co. Ltd. | F-Y3-A Medical Protective Masks | GB19083 | 99.68 | 97.75 |
| Xiamen Luan’an Protective Equipment Co., Ltd. | Eversafe KN95 Self-Priming Filter Respirator | GB2626 | 98.16 | 97.56 |
| Chunyu | Chunyu FFP2 | EN149 | 99.03 | 97.54 |
| Shanghai Huaxiang Woolen Dressing Co., Ltd. | Disposable Mask | GB2626 | 98.51 | 97.48 |
| Zhejiang Lv Mei Biotech Co. | BeBetty Particulate Respirator | GB2626 | 98.71 | 97.1 |
| Rizhao Sanqi Medical & Health Articles Co., Ltd. | 3Q 9505 | GB2626 | 99.39 | 96.95 |
| CSIC Pacli (Nanjng) Tech Co. Ltd. | Filtered Protective Mask KN95 | GB2626 | 97.72 | 96.74 |
| Liaoning Shengjingtang Biotechnology Co., Ltd. | Medical Protective Mask N95 | GB19083 | 98.74 | 96.71 |
| Scotics Science & Technology Co. | SKSS Sterile N95 | GB19083 | 97.36 | 96.65 |
| Guangdong Energy Fortress Pharmaceutical Co., Ltd. | KN95 Protective Respirator | GB2626 | 100 | 95.36 |
| Lanshan Shendun Technology Co., Ltd. | SD-KN95 | GB2626 | 98.14 | 94.91 |
| Anhui Changli Environmental Protection Technology Co., Ltd | KN95 Protective Mask | EN149 | 95.74 | 94.73 |
| Baoji Taidakang Medical Technology Co., Ltd | Medical Protective Mask | GB19083 | 99.27 | 94.3 |
| Zhejiang Allta Industrial Co., LTD | ALLTA Respirator 9591 | GB2626 | 98.08 | 93.61 |
| Delta Plus | CA 38.504 | ABNT/NBR 13698 | 99.43 | 93.09 |
| Senke Pharmaceutical (Chengdu) Co., Ltd. | KN95 Non-Powered Air-Purifying Particulate Respirator | EN149, GB2626 | 98.36 | 92.19 |
| Anhui Kangweijia Labor Protection Articles Co., Ltd. | 9501 Protective Mask | EN149, GB2626 | 98.92 | 92.05 |
| Jiangsu Jiton Clothing Corporation | JT-KN95 Reusable and Sterilizable Nano-mask KN95 | EN149 | 96.74 | 91.61 |
| UNKNOWN | KN95 Ear Face Mask | EN149, GB2626 | 93.6 | 91.55 |
| Daddybaby Co., Ltd. | KN95 4-PLY | EN149 | 93.45 | 91.15 |
| Zhejiang Xingxin Medical Techology Co., Ltd. | KN95 Protective Face Masks | GB2626 | 98.81 | 90.93 |
| Huizhou Huinuo Technology Co., Ltd. | HV-N White KN95 | GB2626 | 94.98 | 90.58 |
| Dongguan Oukangda Medical Technology Co., Ltd. | Kangerda KN95 Particulate Respirator | EN149, GB2626 | 93.68 | 90.28 |
| Flyhorse Industrial Co., Ltd. | FL 0616 | EN149 | 92.58 | 90.18 |
| Kindly Care Products Co., Ltd. | Y-9500 | GB2626 | 91.64 | 89.8 |
| Lamdown | SD-KN95 | GB2626 | 99.22 | 89.6 |
| Huizhou Huinuo Technology Co., Ltd. | HV-N 9501B (Non-Sterile Mask) | GB2626 | 96.55 | 88.81 |
| Changshu City Hengyun Nonwoven Products Co., Ltd. | KN95 Respirator Masks | GB2626 | 97.29 | 88.53 |
| Kindly Care Products Co., Ltd. | Y-9500 | GB2626 | 90.71 | 88.2 |
| Guangzhou Tianyi Zhongliang Biotechnology Group Co., Ltd. | KN95 Disposable Protective Mask | GB2626 | 97.29 | 87.2 |
| CTT Co., Ltd. | KN95 (8410) | EN149, GB2626 | 98.83 | 85.7 |
| UNKNOWN | KN95 Daily Protective Mask | GB2626 | 97.08 | 84.8 |
| Nantong Gold-Sufang Weaving Co. Ltd. | KN95 Face Mask | GB2626 | 93.39 | 84.2 |
| King Year and Packaging Co., Ltd. | Self-Breathing Filtration Particle-Preventive Respirator | EN149, GB2626 | 91.12 | 83.4 |
| King Year and Packaging Co., Ltd. | Self-Breathing Filtration Particle-Preventive Respirator | EN149, GB2626 | 90.03 | 82.7 |
| San Jiao | JS95-01 | EN149 | 89 | 82.4 |
| Hangzhou Senrunqing Technology Co., Ltd. | KN95 Mask-C | EN149, GB2626 | 85.9 | 78.7 |
| UNKNOWN | Haze Mask KN95 | EN149, GB2626 | 81.2 | 78.1 |
| Anhui Jinling Plastics Co., Ltd. | UNKNOWN | GB2626 | 96.13 | 77.6 |
| Huizhou Zhongna Medical Technology Co., Ltd | Anysound KN95 Self-Priming Filter & Anti-Particle Respirator | EN149, GB2626 | 83.41 | 77.3 |
| Guangzhou Kangbang Medical Equipment Co., Ltd. | KN95 Mask | EN149 | 98.86 | 72 |
| Purvigor | KN95 Antibacterial Mask | GB2626 | 74.2 | 69.8 |
| Guangdong Qian Jing Testing Co., LTD. | DNW Protective Mask | EN149, GB2626 | 76.5 | 69.2 |
| Huabai | 9501 | GB2626 | 97.07 | 69 |
| Lanshan Shendun Technology Co., Ltd. | SD-KN95 | GB2626 | 99.71 | 66.8 |
| UNKNOWN | PLOW KN95 | GB2626 | 91.05 | 66.4 |
| Guangdong Fei Fan Mstar Technology LTD | Purvigor KN95 | EN149, GB2626 | 68.83 | 61.6 |
| Jining Jianda Medical Device Technology Co., Ltd. | PM2.5 KN95 | EN149, GB2626 | 64.8 | 59.6 |
| Shenzhen Meili Medical Devices Co., Ltd. | KN95 Protective Mask | EN149, GB2626 | 98.29 | 58.4 |
| Shenzhen Hangsen Star Technology Co., Ltd. | Alchemy KN95 Face Mask A1 | EN149, GB2626 | 92.77 | 56 |
| Ningbo YiXin Intelligentized Science and Technology Co. Ltd. | KN95 (Non-medical) | GB2626 | 59.5 | 53.2 |
| Henan Kang Medical Devices Co., Ltd. | KN95 Protective Mask – KS16 | GB2626 | 97.5 | 52.1 |
| Sinpup Health (Shenzhen) Co., Ltd. | Face Mask KN95 | EN149, GB2626 | 74.3 | 43.1 |
| LitezAll | Wanning Protective Mask | GB2626 | 98.14 | 43 |
| Guanyang Yuhan Textile Co., Ltd. | KN95 Protective Face Mask | GB2626 | 56.59 | 42.15 |
| Zhongshan Cassiey Biotechnology Co., Ltd. | N95 Masks + Particulate Protection Respirator | EN149, GB2626 | 49.5 | 41.5 |
| Garry Galaxy Biotechnology Co., Ltd. | Respirator Mask With TruTone Technology | GB/T 32610 | 44.3 | 35.2 |
| Guangdong Shantou Machinery | KN95 Mask | EN149, GB2626 | 49 | 34.7 |
| UNKNOWN | KN95 | UNKNOWN | 90.5 | 34.6 |
| Changning Lingjiakang Protective Products Factory | KN95 Stereo Protective Mask | EN149 | 50.74 | 33.75 |
| Ningbo Green Health Science & Technology Co., Ltd. | KN95 Protective Mask | GB2626 | 45.8 | 33.2 |
| Tongcheng Chengfeng Protective Equipment Co., Ltd. | Wanhuizhong Anti-Dust Respirator | GB2626 | 59.2 | 32.5 |
| An Hui Su Bo Lun Clothing Co., Ltd. | SU KN95 | GB2626 | 95.1 | 28.45 |
| Zhejiang Kanghao Medical Instruments Co., Ltd. | KN95 Respirator | GB2626 | 50.2 | 28.3 |
| Guangzhou Huashan Biotechnology Co., Ltd. | GF-Mask KN95 Mask | GB2626 | 74.9 | 27.1 |
| Anhui RYZUR Medical Equipment Manufacturing Co., Ltd. | KN95B | EN149, GB2626 | 33.9 | 27 |
| Guangdong Nuokang Medical Technology Co., Ltd. | KN95-Certified Particulate Respirator | GB2626 | 98.73 | 24.22 |
| Dongguan Xianda Medical Equipment Co., Ltd. | KN95 Protective Mask | EN149, GB2626 | 35 | 24.1 |
| Dongguan Oukangda Medical Technology Co., Ltd. | Self-Priming Filter Respirator | GB2626 | 93.76 | 20 |
| Jiangsu Homcan Medical Technology Co., Ltd. | HC-NP95A Self-Priming Filter | EN149 | 51.8 | 17.2 |
| UNKNOWN | KN95 Protective Mask | GB2626 | 68.9 | 14.8 |
| Guangdong Nafei Industrial Holding Co., Ltd. | NAFY Protective Mask | EN149 | 20.4 | 13.9 |
| Kuangye (Dongguan) Technology Co., Ltd. | Geyou KN95 Environmental Protective Respirator | GB2626 | 97.1 | 13.6 |
| Ningbo Green Health Science & Technology Co., Ltd. | Disposable Protective Mask (Non-Medical) | GB2626 | 23.9 | 11.2 |
| Guangdong Nafei Industrial Holding Co., Ltd. | Efficient Nursing Protective Mask | EN149, GB2626 | 10.5 | 1.1 |
■ 已经过NIOSH检测但未能证明最低颗粒过滤效率为95％的防护口罩，可考虑改用作源头控制的口罩，帮助减缓人在讲话，咳嗽或打喷嚏时的感染传播。医疗卫生机构应意识到，这种口罩的功能有别于医护人员的个人防护设备。
■ 使用这些防护口罩的医疗卫生机构，如未通过NOISH检测，在决定用这些产品作口罩时，不妨考虑一些因素，包括当前需求、库存、设备操作和可接受的用途。
▲ FDA认为，在COVID-19大流行期间，不再出现在附录A中的防护口罩，可能无法在任何已授权使用的净化空间中可靠地使用。
▲ 如果您持有从附录A中删除的防护口罩，而且您想让NIOSH检测其过滤效率，您可以通过提交《国际防护口罩评估申请》来要求NIOSH进行检测。
附加信息
医疗卫生机构在考虑购买或使用N95和KN95等防护口罩时，可能会发现以下有用信息：
▲ 标有“respirators（防护口罩）”的产品必须符合FDA的适用要求，或者获得在美国进口和分销的紧急使用授权。但是，标有“face masks（口罩）”而不是“respirators（防护口罩）”的产品有不同的要求，它们进口美国和分销不需要出现在重新发布的EUA的附录A中，不需要出现在2020年3月28日的附件1中，不需要出现在进口防护口罩的EUA中。有关更多信息，请参见《口罩总则EUA》以及《2020年4月冠状病毒疾病（COVID-19）突发公共卫生事件期间口罩及防护口罩的实施政策（修订版）》，《口罩总则EUA》授权了符合某些标准的口罩。
▲ 使用FDA批准或NIOSH批准的防护口罩。在COVID-19突发公共卫生事件期间，FDA授权紧急使用NIOSH批准的用于医疗机构的所有空气净化防护口罩。CDC提供了NIOSH批准的颗粒物过滤式防护口罩和电动净化空气防护口罩的列表。
▲ 如果FDA批准的或NIOSH批准的防护口罩不可用，请考虑使用其他FDA防护口罩紧急使用授权中所涉及的任一项。根据FDA全部的科学证据和其他信息，有理由相信授权的防护口罩可能会有效地防止接触某些颗粒，以防止COVID-19扩散。这些防护口罩列于《2020年3月28日进口、其他国家制造的非NIOSH批准的一次性防护口罩紧急使用授权》的附件1中，或《中国制造的非NIOSH批准的一次性防护口罩紧急使用授权》附录A中。附录A中的清单由FDA定期更新。
▲ 遵循尽职调查做法，例如询问卖方问题，对产品进行物理评估和适合性测试，以做出关于使用防护口罩的最明智的收益风险决策。
▲ 继续确保与医护人员一道进行防护口罩的仔细检测或“合适性检测”，从而实现非常紧密的面部贴合。中国制造的许多防护口罩都有耳环设计。根据CDC的说法，对耳环设计的有限评估表明，可能难以实现适当的贴合度。请遵循您的医疗卫生机构的指导方针进行适合性检测。
▲ 如果先前FDA批准或NIOSH批准的防护口罩可用，而一种新的防护口罩在FDA防护口罩紧急使用授权中所涉及到的任一项却不可用，您可以考虑使用FDA紧急使用授权的消毒设备，受污防护口罩可得到重新利用。请同时注意，如果您使用的是从附录A中删除的防护口罩，那么，这些防护口罩不再由FDA授权一次性使用或由FDA授权的净化系统进行重复使用。
▲ 如果您对防护口罩有任何疑问，或者对防护口罩的包装，标签或质量有任何疑问，请考虑更换、丢弃、或将防护口罩退还给分销商（如适用）。
有关更多信息，请参阅有关非NIOSH批准的过滤式防护口罩的常见问题（FAQ）。
FDA行动
如果有其他可用信息表明防护口罩没有资格被授权，则将其从附录A中删除，并将在FDA的“紧急使用授权”页面上公开通报。
向FDA报告问题
FDA鼓励医疗供应商报告与防护口罩相关的任何不良事件或疑似不良事件。
▲ 自愿报告可以通过MedWatch，FDA安全信息和不良事件报告程序提交。
▲ 设备制造商和用户设施必须遵守适用的《医疗器械报告（MDR）》条例。
▲ 受FDA用户设施报告要求约束的设施雇用的医疗供应商，应遵循其设施规定的报告程序。
▲ 欺诈性COVID-19产品对公共健康构成严重风险。我们鼓励把任何涉及到潜在性的假冒伪劣产品发送至FDA-COVID-19-Fraudulent-Products@fda.hhs.gov。如有可能，请附上产品说明和产品标签图片。
及时报告不良事件有助于FDA识别和更好地了解与医疗器械相关的风险。
注释1：但是，如果防护口罩通过NIOSH的检测，（即，根据NIOSH标准检测程序（STP）TEB-APR-STP-0059的修改版本，证明大于或等于95％的过滤效率），请访问https：// www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0059-508.pdf，并且，在满足最初的第三个标准的基础上，之前已列于附录A中，防护口罩仍然是授权的，并根据修订后的第三项标准列于附录A中。
原文：
Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) is concerned that certain filtering facepiece respirators (respirators) from China may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19 based on additional filtration performance testing conducted by the National Institute for Occupational Safety and Health (NIOSH) - National Personal Protective Technology Laboratory (NPPTL) of the Centers for Disease Control and Prevention (CDC) (referred to below as the NIOSH testing). As such, FDA has revised and reissued the April 3, 2020 EUA as explained below.
On May 7, 2020, the FDA reissued the Emergency Use Authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to revise one of the eligibility criteria – the criterion for authorization of respirators based on review of test reports from recognized independent test laboratories submitted to the FDA by the manufacturer or importer – and accordingly removed from Appendix A the respirators that had been authorized under that criterion, regardless of whether they passed or failed the NIOSH testing.1 The FDA is taking this public health action because a number of these respirators failed to demonstrate a minimum particulate filtration efficiency of 95 percent in testing conducted at NIOSH.
Respirators that were removed from Appendix A of the EUA and that did not meet their labeled performance standard (listed below) are no longer eligible and are no longer authorized to be marketed or distributed in the United States as respirators. They may be re-labeled as face masks and authorized if certain criteria are met under the Face Mask umbrella EUA . For other information, please see FDA’s enforcement policy on face masks, as described in the April 2020 Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)” Guidance.
Non-NIOSH-approved respirators that meet the other eligibility criteria in the reissued Emergency Use Authorization remain authorized by the FDA for use during the COVID-19 pandemic and continue to be listed in Appendix A.
Considerations
Health care facilities with these respirators in inventory should review the considerations listed below. The information is specific to respirators that are designed to achieve a very close facial fit and to filter airborne particles. These considerations are not applicable to surgical masks or face masks that are loose-fitting and create a physical barrier between the health care personnel’s mouth and nose and potential contaminants in the immediate environment.
Respirators that no longer appear in Appendix A may not reliably provide a minimum percent particulate filtration efficiency of 95 percent. Refer to the NIOSH assessment webpage to determine whether non-NIOSH-approved respirators manufactured in China have been tested and to review the testing results.
Among products removed from Appendix A to date, the following failed to demonstrate a minimum percent particulate filtration efficiency of 95 percent in testing conducted by NIOSH:
CTT Co. Ltd
Daddybaby Co. Ltd
Dongguan Xianda Medical Equipment Co., Ltd.
Guangdong Fei Fan Mstar Technology LTD
Guangdong Nuokang Medical Technology Co., Ltd.
Huizhou Huinuo Technology Co., Ltd.
Lanshan Shendun Technology Co
NIOSH regularly updates its list of testing results.
Respirators that have been tested by NIOSH and failed to demonstrate a Minimum Particulate Filtration Efficiency of 95 percent may be considered for use as face masks for source control, to help slow the spread of infection when a person speaks, coughs, or sneezes. Health care facilities should be aware that this use of face masks is different from personal protective equipment for health care personnel.
Health care facilities with these respirators that failed the NOISH testing may wish to consider a number of factors in deciding to use these products as face masks, including current need, inventory, facility practices, and acceptable uses.
The FDA believes respirators that no longer appear in Appendix A may not be reliably decontaminated in any decontamination system authorized for use during the COVID-19 pandemic.
If you have respirators that were removed from Appendix A and you want NIOSH to test their filtration efficiency, you can request NIOSH testing by submitting the International Respirator Assessment Request.
Additional Information
Health care facilities may find the following information useful when considering the purchase or use of respirators such as N95s and KN95s:
Products labeled as “respirators” must meet the applicable FDA requirements or receive an Emergency Use Authorization to be imported and distributed in the United States. However, products labeled as “face masks” and not as “respirators” are subject to different requirements. They do not need to be on Appendix A to the reissued EUA, or on Exhibit 1 to the March 28, 2020, EUA for imported respirators, to be imported and distributed in the United States. For more information, please see the Face Mask umbrella EUA which authorizes face masks that meet certain criteria, as well as the April 2020 Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised).
Use an FDA-cleared or NIOSH-approved respirator. The FDA authorized the emergency use of all NIOSH-approved air purifying respirators for use in healthcare settings during the COVID-19 public health emergency. The CDC provides a list of NIOSH-Approved Particulate Filtering Facepiece Respirators and powered air purifying respirators.
If FDA-cleared or NIOSH-approved respirators are not available, consider using respirators covered under one of the other FDA Emergency Use Authorizations for respirators. Based on the totality of scientific evidence and other information from the FDA, it is reasonable to believe the authorized respirators may be effective at preventing exposure to certain particulates to prevent the spread of COVID-19. These respirators are listed in Exhibit 1 of the March, 28, 2020, Imported, Non-NIOSH Approved Disposable Respirators Emergency Use Authorization for respirators manufactured in other countries, or Appendix A of the Emergency Use Authorization for Non-NIOSH Approved Disposable Respirators manufactured in China. The list in Appendix A is updated by the FDA regularly.
Follow due diligence practices, such as asking questions of the seller, conducting a physical assessment of the product and fit testing, to make the most informed benefit-risk decision about respirator use.
Continue to ensure that careful testing or “fit testing” of respirators is conducted with health care personnel so that a very close facial fit is achieved. Many respirators manufactured in China have an ear loop design. According to the CDC, limited assessment of ear loop designs indicate there may be difficulty achieving a proper fit. Follow your health care facility’s guidelines for conducting fit testing.
If a previously used FDA-cleared or NIOSH-approved respirator is available and a new respirator covered under one of the FDA Emergency Use Authorizations for respirators is not available, you may consider using an FDA Emergency Use Authorization decontamination device for reuse of a compatible contaminated respirator. Please also note that if your facility is using respirators that have been subsequently removed from Appendix A, these respirators are no longer authorized by FDA for single use or reuse by an FDA authorized decontamination system.
If you have concerns about respirators or questions about the packaging, labeling, or quality of the respirators, consider replacing, discarding, or returning the respirators to the distributor, if appropriate.
See Frequently Asked Questions (FAQs) about Non-NIOSH-Approved Filtering Facepiece Respirators for more information.
FDA Actions
The FDA continues to actively monitor and mitigate any potential shortages in the supply chain, including the medical device supply chain. This includes taking action to help assure health care personnel on the front lines have the necessary supplies of personal protective equipment to meet the demand.
The FDA continues to collaborate with the CDC to increase the availability and ensure the integrity of respirators during the COVID-19 public health emergency.
The FDA will continue to keep health care providers and the public informed if new or additional information becomes available.
If additional information becomes available that indicates respirators are not eligible to be authorized, they will be removed from Appendix A and this removal will be publicly communicated on the FDA’s Emergency Use Authorization page.
Reporting Problems to the FDA
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with respirators.
Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
Health care providers employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Fraudulent COVID-19 products pose a serious risk to public health. We encourage any concerns about potential counterfeit or fraudulent product be sent to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov. If possible, please include a description of the product along with a picture of the product’s labeling.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
Contact Information
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).
Additional Resources:
Personal Protective Equipment Emergency Use Authorizations
The FDA’s Video "What is an Emergency Use Authorization?"External Link Disclaimer
NIOSH’s Healthcare Respiratory Protection Resources Fit Testing
The Occupational Safety and Health Administration’s video about Respiratory Protection Fit Testing
The CDC’s Counterfeit Respirators/Misrepresentation of NIOSH-Approval provides information about recognizing counterfeit respirators and recommended best practices for proper respirator use.
However, if a respirator has passed testing by NIOSH (i.e., it demonstrated greater than or equal to 95 percent filtration efficiency per a modified version of NIOSH Standard Test Procedure (STP) TEB-APR-STP-0059), https://www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0059-508.pdf, and was previously listed in Appendix A based on meeting the original third criterion, that respirator remains authorized and listed in Appendix A under the revised third criterion.
