美国撤回多家中国制造商向美出口N95口罩许可_OK阅读网
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美国撤回多家中国制造商向美出口N95口罩许可
F.D.A. Bans Faulty Masks, 3 Weeks After Failed Tests

来源:纽约时报    2020-05-08 03:50



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        The Food and Drug Administration on Thursday barred more than 65 manufacturers in China from exporting N95-style face masks to the United States, citing poor quality.        美国食品和药品监督管理局(Food and Drug Administration,简称FDA)周四以质量差为由,禁止超过65家中国制造商向美国出口N95型口罩。
        In doing so, the FDA slashed the number of Chinese companies approved to sell the masks in the U.S. to 14 from 80.        FDA此举将使获准在美国销售这种口罩的中国公司数量从80家削减至14家。
        N95 masks, which provide better protection against coronavirus particles than cloth or surgical masks, are coveted by health care providers and emergency medical workers. On April 3, drastic shortages of the N95 masks led the FDA to allow imports of similar masks from China.        N95口罩比布质或外科口罩更能抵御新冠病毒,因此备受医护人员和急救医务工作者的青睐。4月3日,由于N95口罩严重短缺,FDA允许从中国进口类似的口罩。
        These imported masks, known as KN95, were never tested by U.S. regulators but were required to be vetted by an accredited test laboratory showing that they met the standards of the Centers for Disease Control and Prevention. Those standards call for filtering 95% of particles that are 0.3 microns or larger, including the new coronavirus.        这些被称为KN95的进口口罩从未经过美国监管机构的检测,但必须通过经认证的检测实验室的审查,以证明其符合美国疾病控制与预防中心(Centers for Disease Control and Prevention,简称CDC)的标准。这些标准要求口罩能够过滤95%直径在0.3微米及以上的颗粒,包括新型冠状病毒。
        As an additional safeguard, the CDC and the FDA initiated their own review to make sure the masks met these performance standards. On Thursday, the FDA said that too many of the Chinese imports failed to filter out a sufficient percentage of particles. Test results showed that numerous companies that were authorized to sell the masks in the U.S. flunked, with one product removing as little as 24% to 35%. The health agencies also tested some KN95 masks that did not have agency approval. One of these, the FDA said, blocked roughly 1% of the particles.        作为额外的保障措施,CDC和FDA启动了他们自己的审查,以确保口罩符合这些性能标准。周四,FDA表示,太多中国进口的口罩未能过滤足量百分比的微粒。测试结果显示,许多获准在美国销售口罩的公司都不合格,其中一款产品的过滤率仅在24%至35%之间。卫生机构还检测了一些未经机构批准的 KN95口罩。FDA说,其中一个只过滤了大约1%的微粒。
                
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