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91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 – 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 – 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
[来源：91仪器信息网译] 未经授权不得转载 美国FDA口罩
