李国杰（经理）：18202125732 电话：021-61062636
美国对口罩的准入要求有哪些？
What are the admission requirements for masks in the United States?
答：美国对***口罩和防护口罩区分管理，其中***口罩由美***品***监督***（FDA）管理，而个人防护口罩则由美国***职业安全卫生研究所（NIOSH）管理。***口罩需通过FDA注册，企业直接向FDA***申请并提交相关材料。此外还有两种可选途径：一是已经获得NIOSH注册的N95口罩，在产品生物学测试、阻燃测试和血液穿透测试通过的情况下，可以豁免产品上市登记（510K），直接进行FDA工厂注册和***器械列名。二是如果获得持有510K的制造商的***，可以作为其代工厂使用其510K批准号进行企业注册和器械列名。个人防护口罩需通过NIOSH注册，企业直接在NIOSH***申请。
A: medical masks and protective masks are managed separately in the United States. Among them, medical masks are managed by the U.S. Food and Drug Administration (FDA), while personal protective masks are managed by the National Institute of occupational safety and health (NIOSH). Medical masks need to be registered with FDA, and enterprises directly apply to the FDA website and submit relevant materials. In addition, there are two alternative ways: first, N95 masks that h***e obtained NIOSH registration can be exempted from listing registration (510k) when the biological test, flame retardant test and blood penetration test of the products pass, and FDA factory registration and medical device listing can be conducted directly. Second, if authorized by the manufacturer holding 510k, it can use its 510k approval number as its representative factory for enterprise registration and device listing. Personal protective masks need to be registered with NIOSH, and enterprises directly apply on NIOSH official website.
美国对防护服的准入要求有哪些？
What are the entry requirements for protective clothing in the United States?
答：美国对***防护服和个人防护服的管理也类似于口罩的管理方式，其中***防护服由美***品***监督***（FDA）管理，而个人防护服由美国***职业安全卫生研究所（NIOSH）管理。企业直接在FDA或NIOSH进行注册申请。
A: the management of medical protective clothing and personal protective clothing in the United States is similar to the management of masks. The medical protective clothing is managed by the U.S. Food and Drug Administration (FDA), while the personal protective clothing is managed by the National Institute of occupational safety and health (NIOSH). Enterprises directly apply for registration in FDA or NIOSH.
李国杰（经理）：18202125732 电话：021-61062636
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