美國對口罩的準入要求有哪些？

What are the admission requirements for masks in the United States?

答：美國對醫用口罩和防護口罩區分管理，其中醫用口罩由美國食品藥品監督管理局（FDA）管理，而個人防護口罩則由美國國家職業安全衛生研究所（NIOSH）管理。醫用口罩需通過FDA注冊，企業直接向FDA官網申請并提交相關材料。此外還有兩種可選途徑：一是已經獲得NIOSH注冊的N95口罩，在產品生物學測試、阻燃測試和血液穿透測試通過的情況下，可以豁免產品上市登記（510K），直接進行FDA工廠注冊和醫療器械列名。二是如果獲得持有510K的制造商的授權，可以作為其代工廠使用其510K批準號進行企業注冊和器械列名。個人防護口罩需通過NIOSH注冊，企業直接在NIOSH官網申請。

A: medical masks and protective masks are managed separaby 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 b relevant materials. In addition, there are two alternative ways: first, N95 masks that have 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.

美國對防護服的準入要求有哪些？

What are the entry requirements for protective clothing in the United States?

答：美國對醫用防護服和個人防護服的管理也類似于口罩的管理方式，其中醫用防護服由美國食品藥品監督管理局（FDA）管理，而個人防護服由美國國家職業安全衛生研究所（NIOSH）管理。企業直接在FDA或NIOSH進行注冊申請。

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.

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