仪器信息网讯 当地时间5月7日，美国食品和药物监督管理局（FDA，下称“美食药监局”）在官网向全体医护人员致信称，因一部分来自中国的口罩无法在新冠肺炎疫情期间起到足够的保护作用，他们已取消了一些中国制造商在美国销售N95口罩的许可。
美食药监局表示，他们发现有60多家中国制造商的口罩质量不合格，因此将准许在美销售的中国口罩制造商数量由80家减少到14家。
由于新冠肺炎疫情大流行的原因，个人防护用品的需求激增，N95口罩因为可以过滤至少95%的空气颗粒物，在疫情期间被美国疾病预防与控制中心（CDC，下称美疾控中心）列为重要的防护用品。
美疾控中心下属的美国国家职业安全卫生研究所（NIOSH）最近在对67种不同类型的进口N95口罩进行检测后发现，有约六成产品的过滤效果未达到美国N95口罩标准。
同时，NIOSH的测试还发现，7日被取消出口许可的一家中国公司的口罩只能过滤掉24%-35%的颗粒物，远低于N95口罩命名所要求的过滤95%颗粒物的标准，而这款口罩的包装上宣称过滤级别为五星级，并使用了未经授权的FDA标志。
正因为上述情况，美食药监局决定取消多家中国制造商在美销售N95口罩的许可。这也意味着美食药监局推翻了4月3日所作出的一项决定（当时，他们允许一些未经美国政府检测的制造商出口口罩到美国，只要通过一家独立实验室的审查即可）。
在迄今为止已从准许名单中删除的产品中，下列产品未能在NIOSH进行的测试中显示出至少95％的最小颗粒过滤效率：
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会定期更新其测试结果列表（文末附截至5月8日测试结果表）。
在德国从事口罩进出口贸易的业内人士曾指出，新冠疫情爆发前，国际上没有对口罩质量标准的统一规定，也缺乏权威的质量认证机制，这才是最大问题所在。
中国外交部发言人耿爽日前在记者会上表示，中方高度重视出口防疫医疗物资质量问题，近期商务部会同海关总署、药监局、市场监管总局已就有序开展医疗物资出口、加强质量监管出台了多项举措。防疫物资出口中出现的质量问题，很多是因为中外质量标准不同，使用习惯存在差异，外方未严格按照产品用途使用造成的。 耿爽表示，中方将会继续严格执行监管政策，确保防疫物资出口质量，同时也希望外方加强采购商在进口环节的质量检测，并严格按照产品的适用范围和操作规程正确使用。
附：NIOSH测试结果列表（截至5月8日更新）
Manufacturer | Model Number/Product Line | International Standard | Filtration Efficiency (%) | Test Report | |
Maximum | Minimum | ||||
Anhui Baishidun Protective Equipment Co., Ltd. | Baishidun FFP2 | EN149, GB2626 | 53.00 | 46.10 | 2020-51.1pdf icon |
Anhui Changli Environmental Protection Technology Co., Ltd | KN95 Protective Mask | EN149 | 95.74 | 94.73 | 2020-50.1pdf icon |
Anhui Hongqiaosi Hometextile Co., Ltd. | KN95 Disposable Protective Face Mask | UNKNOWN | 99.80 | 99.64 | 2020-80.2pdf icon |
Anhui Jinling Plastics Co., Ltd. | UNKNOWN | GB2626 | 96.13 | 77.60 | 2020-21.1pdf icon |
Anhui Jinling Plastics Company Limited | Protective Mask | EN149 | 99.66 | 98.67 | 2020-59.1pdf icon |
Anhui Kangweijia Labor Protection Articles Co., Ltd. | 9501 Protective Mask | EN149, GB2626 | 98.92 | 92.05 | 2020-86.1pdf icon |
Anhui RYZUR Medical Equipment Manufacturing Co., Ltd. | KN95B | EN149, GB2626 | 33.90 | 27.00 | 2020-66.3pdf icon |
An Hui Su Bo Lun Clothing Co., Ltd. | SU KN95 | GB2626 | 95.10 | 28.45 | 2020-55.1pdf icon |
Baoji Taidakang Medical Technology Co., Ltd | Medical Protective Mask | GB19083 | 99.27 | 94.30 | 2020-47.1pdf icon |
Changning Lingjiakang Protective Products Factory | KN95 Stereo Protective Mask | EN149 | 50.74 | 33.75 | 2020-10.3pdf icon |
Changshu City Hengyun Nonwoven Products Co., Ltd. | KN95 Respirator Masks | GB2626 | 97.29 | 88.53 | 2020-78.3pdf icon |
Chunyu | Chunyu FFP2 | EN149 | 99.03 | 97.54 | 2020-06.1pdf icon |
CTT Co., Ltd. | KN95 (8410) | EN149, GB2626 | 98.83 | 85.70 | 2020-87.1pdf icon |
CSIC Pacli (Nanjng) Tech Co. Ltd. | Filtered Protective Mask KN95 | GB2626 | 97.72 | 96.74 | 2020-28.1pdf icon |
Daddybaby Co., Ltd. | KN95 4-PLY | EN149 | 93.45 | 91.15 | 2020-29.4pdf icon |
Delta Plus | CA 38.504 | ABNT/NBR 13698 | 99.43 | 93.09 | 2020-45.2pdf icon |
Dobu Life Tech Co., Ltd. | Dobu #201 | KMOEL | 99.94 | 99.85 | 2020-115.2pdf icon |
Dongguan Oukangda Medical Technology Co., Ltd. | Self-Priming Filter Respirator | GB2626 | 93.76 | 20.00 | 2020-78.4pdf icon |
Dongguan Oukangda Medical Technology Co., Ltd. | Kangerda KN95 Particulate Respirator | EN149, GB2626 | 93.68 | 90.28 | 2020-78.5pdf icon |
Dongguan Xianda Medical Equipment Co., Ltd. | KN95 Protective Mask | EN149, GB2626 | 35.00 | 24.10 | 2020-23.1pdf icon |
Dongguan Xianda Medical Equipment Co., Ltd. | KN95 Protective Mask | GB2626 | 99.63 | 99.47 | 2020-120.1pdf icon |
Flyhorse Industrial Co., Ltd. | FL 0616 | EN149 | 92.58 | 90.18 | 2020-75.1pdf icon |
Gaomi City Hancheng Personal Protective Products Co., Ltd. | Baokangjie 9001 | GB2626 | 99.15 | 98.19 | 2020-57.3pdf icon |
Garry Galaxy Biotechnology Co., Ltd. | Respirator Mask With TruTone Technology | GB/T 32610 | 44.30 | 35.20 | 2020-119.1pdf icon |
Guangdong Energy Fortress Pharmaceutical Co., Ltd. | KN95 Protective Respirator | GB2626 | 100.00 | 95.36 | 2020-77.2pdf icon |
Guangdong Fei Fan Mstar Technology LTD | Purvigor KN95 | EN149, GB2626 | 68.83 | 61.60 | 2020-10.2pdf icon |
Guangdong Medical Technology Co., Ltd. | KN95 Stereo Protective Mask | EN149 | 99.18 | 97.91 | 2020-102.1pdf icon |
Guangdong Nafei Industrial Holding Co., Ltd. | Efficient Nursing Protective Mask | EN149, GB2626 | 10.50 | 1.10 | 2020-78.8pdf icon |
Guangdong Nafei Industrial Holding Co., Ltd. | NAFY Protective Mask | EN149 | 20.40 | 13.90 | 2020-63.1pdf icon |
Guangdong Nuokang Medical Technology Co., Ltd. | KN95-Certified Particulate Respirator | GB2626 | 98.73 | 24.22 | 2020-60.1pdf icon |
Guangdong Qian Jing Testing Co., LTD. | DNW Protective Mask | EN149, GB2626 | 76.50 | 69.20 | 2020-18.1pdf icon |
Guangdong Shantou Machinery | KN95 Mask | EN149, GB2626 | 49.00 | 34.70 | 2020-37.1pdf icon |
Guangdong Zhizhen Biological Medicine Co., Ltd. | KN95 Three-Dimensional Protective Respirator | GB2626 | 89.80 | 88.70 | 2020-124.1pdf icon |
Guangzhou Baoweikang (Powecom) Personal Protection Equipment Co., Ltd. | KN95 Protective Mask | GB2626 | 99.40 | 99.21 | 2020-49.1pdf icon |
Guangzhou Harley Commodity Co., Ltd. | L-103V KN95 | GB2626 | 99.49 | 99.02 | 2020-95.1pdf icon |
Guangzhou Huashan Biotechnology Co., Ltd. | GF-Mask KN95 Mask | GB2626 | 74.90 | 27.10 | 2020-78.1pdf icon |
Guangzhou Kangbang Medical Equipment Co., Ltd. | KN95 Mask | EN149 | 98.86 | 72.00 | 2020-68.1pdf icon |
Guangzhou Sunjoy Auto Supplies Co., Ltd. | K1 Self Suction Filter Respirator | GB2626 | 43.70 | 12.30 | 2020-118.1pdf icon |
Guangzhou Tianyi Zhongliang Biotechnology Group Co., Ltd. | KN95 Disposable Protective Mask | GB2626 | 97.29 | 87.20 | 2020-65.1pdf icon |
Guanyang Yuhan Textile Co., Ltd. | KN95 Protective Face Mask | GB2626 | 56.59 | 42.15 | 2020-36.1pdf icon |
Hangzhou Senrunqing Technology Co., Ltd. | KN95 Mask-C | EN149, GB2626 | 85.90 | 78.70 | 2020-67.1pdf icon |
Henan Kang Medical Devices Co., Ltd. | KN95 Protective Mask C KS16 | GB2626 | 97.50 | 52.10 | 2020-97.1pdf icon |
Honeywell Safety Products (Shanghai) Co., Ltd. | H801 Particulate Respirator | GB2626 | 99.32 | 98.40 | 2020-61.1pdf icon |
Huabai | 9501 | GB2626 | 97.07 | 69.00 | 2020-29.3pdf icon |
Huizhou Huinuo Technology Co., Ltd. | HV-N 9501B (Non-Sterile Mask) | GB2626 | 96.55 | 88.81 | 2020-22.2pdf icon |
Huizhou Huinuo Technology Co., Ltd. | HV-N White KN95 | GB2626 | 94.98 | 90.58 | 2020-113.1pdf icon |
Huizhou Zhongna Medical Technology Co., Ltd | Anysound KN95 Self-Priming Filter Anti-Particle Respirator | EN149, GB2626 | 83.41 | 77.30 | 2020-56.3pdf icon |
Jiande Chaomei Daily Chemicals Co., Ltd. | CM 9527 | GB19083 | 99.29 | 97.87 | 2020-39.1pdf icon |
Jiande Chaomei Daily Chemicals Co. Ltd. | F-Y3-A Medical Protective Masks | GB19083 | 99.68 | 97.75 | 2020-77.3pdf icon |
Jiande Chaomei Daily Chemicals Co. Ltd. | 6005-1 | GB2626 | 99.19 | 98.73 | 2020-110.1pdf icon |
Jiangmen Huayue Industrial Co., Ltd. | HY9501 Folding Mask C KN95 | GB2626 | 99.55 | 98.48 | 2020-72.1pdf icon |
Jiangsu Homcan Medical Technology Co., Ltd. | HC-NP95A Self-Priming Filter | EN149 | 51.80 | 17.20 | 2020-66.2pdf icon |
Jiangsu Jiton Clothing Corporation | JT-KN95 Reusable and Sterilizable Nano-mask KN95 | EN149 | 96.74 | 91.61 | 2020-10.1pdf icon |
Jiangsu Newborn Medical Technology Co., Ltd. | Protective Mask KN95 | GB2626 | 97.07 | 50.70 | 2020-113.2pdf icon |
Jinhua Jiadaifu Medical Supplies Co., Ltd. | KN95 Face Mask (Non-Medical) | GB2626 | 99.57 | 54.90 | 2020-113.3pdf icon |
Jining Jianda Medical Device Technology Co., Ltd. | PM2.5 KN95 | EN149, GB2626 | 64.80 | 59.60 | 2020-21.3pdf icon |
Kindly Care Products Co., Ltd. | Y-9500 | GB2626 | 91.64 | 89.80 | 2020-66.1pdf icon |
Kindly Care Products Co., Ltd. | Y-9500 | GB2626 | 90.71 | 88.20 | 2020-79.1pdf icon |
King Year and Packaging Co., Ltd. | Self-Breathing Filtration Particle-Preventive Respirator | EN149, GB2626 | 90.03 | 82.70 | 2020-62.2pdf icon |
King Year and Packaging Co., Ltd. | Self-Breathing Filtration Particle-Preventive Respirator | EN149, GB2626 | 91.12 | 83.40 | 2020-62.1pdf icon |
Kuangye (Dongguan) Technology Co., Ltd. | Geyou KN95 Environmental Protective Respirator | GB2626 | 97.10 | 13.60 | 2020-78.2pdf icon |
Laianzhi | KLT01 | GB2626 | 99.68 | 97.83 | 2020-06.2pdf icon |
Lamdown | SD-KN95 | GB2626 | 99.22 | 89.60 | 2020-71.1pdf icon |
Lanshan Shendun Technology Co., Ltd. | SD-KN95 | GB2626 | 98.14 | 94.91 | 2020-80.1pdf icon |
Lanshan Shendun Technology Co., Ltd. | SD-KN95 | GB2626 | 99.71 | 66.80 | 2020-69.1pdf icon |
Liaoning Shengjingtang Biotechnology Co., Ltd. | Medical Protective Mask N95 | GB19083 | 98.74 | 96.71 | 2020-20.1pdf icon |
LitezAll | Wanning Protective Mask | GB2626 | 98.14 | 43.00 | 2020-56.2pdf icon |
Nantong Gold-Sufang Weaving Co. Ltd. | KN95 Face Mask | GB2626 | 93.39 | 84.20 | 2020-56.1pdf icon |
Ningbo Green Health Science Technology Co., Ltd. | KN95 Protective Mask | GB2626 | 45.80 | 33.20 | 2020-54.1pdf icon |
Ningbo Green Health Science Technology Co., Ltd. | Disposable Protective Mask (Non-Medical) | GB2626 | 23.90 | 11.20 | 2020-117.1pdf icon |
Ningbo YiXin Intelligentized Science and Technology Co. Ltd. | KN95 (Non-medical) | GB2626 | 59.50 | 53.20 | 2020-86.2pdf icon |
Purvigor | KN95 Antibacterial Mask | GB2626 | 74.20 | 69.80 | 2020-33.1pdf icon |
Qingdao Hainuo Bioengineering Co., Ltd. | Hynaut KN95 Protective Face Mask | GB2626 | 98.37 | 97.98 | 2020-96.1pdf icon |
Qingdao Maysheng Medical Devices Co., Ltd | KN95 Protective Mask (Self Suction Filter Respirator FFP2) | GB2626 | 99.59 | 99.30 | 2020-45.1pdf icon |
Rizhao Sanqi Medical Health Articles Co., Ltd. | 3Q 9505 | GB2626 | 99.39 | 96.95 | 2020-29.1pdf icon |
San Jiao | JS95-01 | EN149 | 89.00 | 82.40 | 2020-104.1pdf icon |
Scotics Science Technology Co. | SKSS Sterile N95 | GB19083 | 97.36 | 96.65 | 2020-22.1pdf icon |
Shandong Tricol Marine Biological Technology Co., Ltd. | KN95 Particulate Respirator for PPE with Headstrap + Hook | GB2626 | 99.57 | 98.71 | 2020-115.1pdf icon |
Shanghai Dasheng Health Products Manufacture Co., Ltd. | DTC3B | USA (claimed, 42 CFR 84) | 99.76 | 99.67 | 2020-57.1pdf icon |
Shanghai Dasheng Health Products Manufacture Co., Ltd. | DTC3X | USA (claimed, 42 CFR 84) | 99.95 | 99.58 | 2020-57.2pdf icon |
Shanghai Dasheng Health Products Manufacture Co., Ltd. | DTC3B-1 | GB2626 | 99.92 | 99.83 | 2020-77.1pdf icon |
Shanghai Dasheng Health Products Manufacture Co., Ltd. | DTC3X (Sample Group 1 of 3) | USA (claimed, 42 CFR 84) | 99.66 | 98.32 | 2020-94.1pdf icon |
Shanghai Dasheng Health Products Manufacture Co., Ltd. | DTC3X (Sample Group 2 of 3) | USA (claimed, 42 CFR 84) | 99.63 | 99.31 | 2020-94.2pdf icon |
Shanghai Dasheng Health Products Manufacture Co., Ltd. | DTC3X (Sample Group 3 of 3) | USA (claimed, 42 CFR 84) | 99.76 | 99.34 | 2020-94.3pdf icon |
Shanghai Dasheng Health Products Manufacture Co., Ltd. | DTC3X | USA (claimed, 42 CFR 84) | 99.84 | 99.45 | 2020-119.2pdf icon |
Shanghai Gangkai Purifying Products Co., Ltd. | 8012 | GB2626 | 99.13 | 98.11 | 2020-58.1pdf icon |
Shanghai Huaxiang Woolen Dressing Co., Ltd. | Disposable Mask | GB2626 | 98.51 | 97.48 | 2020-53.1pdf icon |
Senke Pharmaceutical (Chengdu) Co., Ltd. | KN95 Non-Powered Air-Purifying Particulate Respirator | EN149, GB2626 | 98.36 | 92.19 | 2020-78.9pdf icon |
Shenzhen Hangsen Star Technology Co., Ltd. | Alchemy KN95 Face Mask A1 | EN149, GB2626 | 92.77 | 56.00 | 2020-84.1pdf icon |
Shenzhen Kawang Network Technology Co., Ltd. | FFP3 | EN149 | 99.17 | 98.77 | 2020-21.2pdf icon |
Shenzhen Meili Medical Devices Co., Ltd. | KN95 Protective Mask | EN149, GB2626 | 98.29 | 58.40 | 2020-90.1pdf icon |
Sinpup Health (Shenzhen) Co., Ltd. | Face Mask KN95 | EN149, GB2626 | 74.30 | 43.10 | 2020-90.2pdf icon |
Suzhou Jinruida Protective Equipment Co, Inc. | KN95 Three Dimensional Respirator | GB2626 | 99.31 | 97.87 | 2020-34.1pdf icon |
Te Yin | TY0929 FFP2 NR | EN149 | 99.70 | 98.89 | 2020-43.1pdf icon |
Tongcheng Chengfeng Protective Equipment Co., Ltd. | Wanhuizhong Anti-Dust Respirator | GB2626 | 59.20 | 32.50 | 2020-98.1pdf icon |
UNKNOWN | UNKNOWN | GB2626 | 99.60 | 98.14 | 2020-29.2pdf icon |
UNKNOWN | KN95 Ear Face Mask | EN149, GB2626 | 93.60 | 91.55 | 2020-42.1pdf icon |
UNKNOWN | KN95 Daily Protective Mask | GB2626 | 97.08 | 84.80 | 2020-56.4pdf icon |
UNKNOWN | KN95 Protective Mask | GB2626 | 68.90 | 14.80 | 2020-67.2pdf icon |
UNKNOWN | KN95 | UNKNOWN | 90.50 | 34.60 | 2020-70.1pdf icon |
UNKNOWN | Haze Mask KN95 | EN149, GB2626 | 81.20 | 78.10 | 2020-82.1pdf icon |
UNKNOWN | PLOW KN95 | GB2626 | 91.05 | 66.40 | 2020-15.1pdf icon |
Xiamen Lixia Medical Technology Co., Ltd. | Lixia Medical Respirator | GB2626 | 99.96 | 99.31 | 2020-78.10pdf icon |
Xiamen Luan’an Protective Equipment Co., Ltd. | Eversafe KN95 Self-Priming Filter Respirator | GB2626 | 98.16 | 97.56 | 2020-109.1pdf icon |
Zhandjiagang Meijie Commodity Co., Ltd | MJ-N02A (Particulate Respirator) | GB2626 | 99.47 | 98.55 | 2020-26.1pdf icon |
Zhangjiagang Zhiyi Medical Materials Co. | Self-Priming Filter Respirator KN95 | GB19083 | 99.26 | 97.93 | 2020-13.1pdf icon |
Zhejiang Allta Industrial Co., LTD | ALLTA Respirator 9591 | GB2626 | 98.08 | 93.61 | 2020-32.1pdf icon |
Zhejiang Kanghao Medical Instruments Co., Ltd. | KN95 Respirator | GB2626 | 50.20 | 28.30 | 2020-78.7pdf icon |
Zhejiang Lv Mei Biotech Co. | BeBetty Particulate Respirator | GB2626 | 98.71 | 97.10 | 2020-56.5pdf icon |
Zhejiang Xingxin Medical Techology Co., Ltd. | KN95 Protective Face Masks | GB2626 | 98.81 | 90.93 | 2020-78.6pdf icon |
Zhongshan Cassiey Biotechnology Co., Ltd. | N95 Masks + Particulate Protection Respirator | EN149, GB2626 | 49.50 | 41.50 | 2020-92.1pdf icon |