美国确诊超55万例,紧急授权KN95,26家中国公司拿到口罩出口通行证
根据荷兰媒体 bnO 新闻发布的最新数据，在过去 24 小时内，美国有 27243 例新病例和 1555 例新死亡病例，被确诊为 coVID-19 。该媒体一直在跟踪全球 COVID-19 疫情数据。到目前为止，美国确认的 COVID-19 病例累计已达 587752 例，累计死亡人数已达到 23765 例。
根据美国食品和药物管理局（fda) 网站上的最新文件，中国共有 46 家工厂口罩制造商已获准紧急使用（EUA)。" 除 3M 中国、创意理念等外商投资企业外，其他企业均为中国各地的制造商，包括广东、山东、河南、四川、江苏等地。在获得紧急授权的企业中，有 26 家使用中国 KN 95 标准生产口罩。
ManufACTurer | Respirator Model(s) | Country OF Manufacture | |
3M | 9001, 9002, 9501, 9501+, 9501V+, | China | |
9502, 9502+, 9502V+, 9505+, 9541, | |||
9541V, 9542, 9542V, 9552, 9552V | |||
Allmed | kn95 Particulate Respirator | China | |
LP220002 | |||
Anshun Health and | AKF2002 | China | |
Medical | |||
Technology Co., | |||
LTD | |||
AOK Tooling Ltd. | 20130040, 20130045A, 20180021, | China | |
(aka Shenzhonghai | 20130038, 20190019 | ||
Medical) | |||
Bei Bei Safety Co | B702, B702V, B704, B704V | China | |
Ltd. | |||
Bei Bei (dong | B707 | China | |
Shan) Protective | |||
Supplies Co., LTD | |||
BYD Precision | BYD KN95 Particulate Respirator | China | |
Manufacture Co. | (Model Number: DG3101) | ||
Ltd. | |||
Changsha JNEYL | JN-9501 | China | |
Medical Equipment | |||
Co., Ltd | |||
Chengde | KN95 (PM 2.5) Protective Mask | China | |
Technology Co. | |||
China Nano | ZN6005 | China | |
Technology Co., | ZN8005 | ||
Ltd | |||
Chongqing China | KN95 ZN6005 | China | |
Nano Technology | |||
Co., Ltd. | |||
Creative ConCEpts | 02669, 02676, KN95 | China | |
Manufacturing Ltd | |||
CTT CO. Ltd. | KN95 | China | |
Dongguan | KN95-A; KN95-B | China | |
Huagang | |||
Communication | |||
Technology C. Ltd | |||
Dongguan Leihuo | CPFM-100, CPFM-101, LH-KN95 | China | |
Medical Device | |||
Co., LTD | |||
Dongguan Sengtor | KN95 | China | |
Plastics Products | |||
Co., Ltd. | |||
Dongguan Xianda | KN95 | China | |
Medical Equipment | |||
Co., Ltd | |||
Fujian Kang Chen | K0450, 57793 | China | |
Daily Necessities | |||
Co, Ltd. | |||
Fujian Pageone | KN95 | China |
Garment Co., Ltd | ||
Fujian Yongtai | N95 | China |
Sanlian Garment | ||
Co., Ltd. | ||
Guangzhou | A&F KN95 | China |
Aiyinmei Co., LTD | ||
Guangdong Fei Fan | KN95 | China |
MStar Technology | ||
Ltd. | ||
Guangdong Golden | 8862 KN95 | China |
Leaves Technology | ||
Development Co., | ||
Ltd. | ||
Guangzhou Harley | L-130V KN95 | China |
Commodity | ||
Company Limited | ||
Guangzhou | PPDS N95 Respirator and Surgical | China |
Improve Medical | Mask Model No. PPDS Ear Hook M | |
Instruments Co., | ||
LTD | ||
Guangdong | KN95 | China |
Nuokang Medical | ||
Technology Co., | ||
Ltd. | ||
Guangzhou | KN95 | China |
powecom Labor | ||
Insurance Supplies | ||
Co., LTD | ||
Guangzhou Sunjoy | Earhook folding type K1-K100 | China |
Auto Supplies Co., | Headband folding type K1-K100 | |
LTD | ||
Guangdong Kaper | KP-K02 (N95) | China | |
Protection | |||
Technology Co., | |||
Ltd | |||
Guangdong | KN95 | China | |
ZhiZhen Biological | |||
Medicine Co., LTD | |||
Guizhou Bocai | Bocai KN95 | China | |
Medical Device | |||
Co., Ltd. | |||
HeiQ Materials AG | HVB-ffP2-01 | China | |
Henan | HF/KN95-3 | China | |
Fengzhihuang | |||
Industrial Co., Ltd | |||
Henan Youmaisi | YMS-AN95 | China | |
Health Technology | |||
Co. LTD | |||
Huizhou Huinuo | HV-N White 9501A, HV-N White | China | |
Technology Co., | 9501B | ||
LTD | |||
Huizhou Jiahe | KN95 | China | |
Cubic Technology | |||
Co., LTD | |||
Huizhou | LK-003 | China | |
Lexuslance | |||
Technology Co. Ltd | |||
Improve Medical | PPDS Strap Headband M | China | |
(Hunan) Co. Ltd. | PPDS Ear Hook M | ||
Jiangsu | WCL-0075 | China | |
Weichuangli New | |||
Materials Co., Ltd. | |||
Jiangsu Yimao | 9570K | China |
Filter Media Co., | ||
Ltd | ||
Jiangxi Hornet | S-KN95 | China |
Industrial Co. Ltd. | ||
Jiangxi Yifengyuan | N95, KN95 | China |
Biological | ||
Engineering Co., | ||
Ltd. | ||
Jinhua Jiadaifu | KN95 FFP2 | China |
Medical Supplies | ||
Co. Ltd | ||
Jinan Vhold Co., | VH-95 | China |
LTD | ||
Juntech (Jiaxing) | KN95 | China |
HealTHCare | ||
Materials Co. Ltd | ||
Lanshan Shendun | SD-KN95-01, SD-KN95-02, SD-KN95- | China |
Technology Co. | C01, SDKN95-C02 | |
Panzhihua | KN95 | China |
Gangcheng Group | ||
Yasheng Industrial | ||
Co., Ltd. | ||
Qingdao Orphila | OM-KN95-FFP2 | China |
Medical | ||
Technology Co. | ||
LTD. | ||
Qingyuan Leite | GV-0095A, GVHKN95 | China |
Technology | ||
Development Co. | ||
Raxwell Industrial | RX9501 | China |
Technology | ||
(Shanghai) Co., Ltd. | ||
Rizhao Sanqi | RIZ100CVb, 3Q KN95, 3Q FFP2 NR, | China |
Medical & Health | RIZQ100Sb, 3Q KN95 9505 | |
Articles Co., Ltd | ||
Shandong Daddy's | Purism KN95 | China |
Choice Health | ||
science and | ||
Technology Co., | ||
Ltd | ||
Shandong | KN95 | China |
Huishoutang | ||
Pharmaceutical Co | ||
Shandong | snN70370B (Willow leaf form | China |
Shengquan New | valveless) | |
Material Co., Ltd | ||
Shanghai Dasheng | DTC3X-1, DTC3X-2, DTC3X-3, | China |
Health Products | DTC3B-1 | |
Manufacture | ||
Company, Ltd. | ||
Shanghai Yunqing | YQD95 KN95 | China |
Industrial Co.,Ltd. | ||
Shauguan Taijie | KN95 | China |
Protection | ||
Technology Co. | ||
Ltd. | ||
Shenzhen Horb | 1.7.02.02.0001 | China |
Technology Corp., | ||
Ltd | ||
Shenzhen | 2626-1 KN95 | China |
Missadola | ||
Technology Co., | ||
Ltd, dba 1AK | ||
Medical Supplies | ||
Sunright Medical | KN95-C3 | China |
Technology | ||
(GuangDong) Co., | ||
LTD | ||
Suzhou Bolisi | BS-9501L, BS-9501FL, BS-9502C, BS- | China |
Medical | 9502FC | |
Technology Co., | ||
Ltd | ||
Tianjin Benmo | KN95 | China |
Medical Equipment | ||
Co., Ltd. | ||
Weini Technology | FFP2 NR E-300, FFP2 NR E-680, | China |
Development Co., | FFP2 NR 952, FFP2 NR F-820, KN95 | |
Ltd | 958, KN95 951 | |
Winner Medical | WN-N95FW, WN-N95FG, WN- | China |
Co. Ltd. | N95FGIN | |
Yiwu Henghao | HH-KN95-001 | China |
household | ||
products Co., Ltd | ||
Yiwu Yifan Knitting | KN95 | China |
Co. Ltd | ||
Zhangzhou Easepal | MASK-104 | China |
Industrial Corp. | ||
Zhejiang Baiyi | KN95 | China |
Intelligent | ||
Garment Co LTD | ||
Zhejiang Shengtai | KN95 | China |
Baby Products Co | ||
Ltd | ||
Zhende Medical | N9501F | China |
Co., LTD | ||
Zhengzhou Ripe | Disposable Protective Mask KN95 | China |
Medical | ||
Technology Co., | ||
LTD | ||
Zhengzhou Ruipu | KN95 | China |
Medical | ||
Technology Co.,Ltd | ||
Zhengzhou | KN95 | China |
WanshENShan | ||
HealtHCare PPE | ||
Co., Ltd. | ||
ZhongKang | ZK601 | China |
protective | ||
equipment | ||
technology | ||
(Guangzhou) Co., | ||
Ltd | ||
根据 FDA 的文件，中国制造的口罩是由 EUA 授权的，需要满足以下三项要求：
1.具有一种或多种 NIOSH(国家职业安全和健康研究所）认证产品的制造商、其他类型的过滤口罩（FFR)、按照其他国家适用的授权标准生产的 FDA 都可以得到验证；
2.经中国境外其他地区授权，FDA 可予以验证；
3.有一个独立的测试实验室发布了测试报告，可以证明其产品性能符合适用的测试指标，可以通过 FDA 进行验证。
据报道，KN 95 口罩符合国家一类口罩颗粒过滤效率国家标准，是国家安全生产监督管理局提出的中国强制性国家标准。从适用范围上看，该标准适用于一般自吸过滤器呼吸防护设备，以保护各种颗粒物。
N95 是指国家职业安全卫生研究院（NIOSH) 认证的 9 种微粒防护面罩之一。总体而言，KN 95 口罩和 N95 口罩在颗粒过滤效率方面大致相同。
据报道，FDA 已将中国标准 KN 95 口罩排除在授权范围之外，新发布的文件标志着美国监管机构正式批准按照中国标准生产的 KN 95 口罩。
商务部：由于防疫产品质量好，外方退货，通知两家公司
4 月 14 日，根据商务部网站，商务部发布了 "关于禁止两家公司出口防疫产品的通知"：
在实施防疫产品出口的过程中，一些企业因产品质量问题，扰乱了防疫产品的出口秩序，严重影响了国家形象。现在停止北京启蒙运动集团连锁技术发展有限公司、艾宝达科技（深圳）有限公司的防疫产品出口。
两家公司暂停出口防疫产品，是国内出口企业的警钟，也是国际抗病力的责任，希望所有企业都以此为警示！
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