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United States. Classified as either a Class 1 or Class 2 medical device, in the US medical masks must meet the labeling requirements of the relevant regulations. Some medical masks may be classified as “source control” per Emergency Use Authorization (see link in "COVID-19 Regulatory Updates & Advice >"). Contact us for more details > EU

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Only when the disposable face mask meets the following requirements it can be called the medical Surgical face mask Filtration efficiency Under the condition of air flow (30 ± 2) L / min, the filtration efficiency of the Surgical Face Mask for aerodynamic median diameter (0.24 ± 0.06) μm sodium chloride aerosol is not less than 30%;

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Apr 07, 2020 · Try our Product Compliance Software Tool Here. Planning to import N95, N99 or other face masks into the United States? In this guide, we cover the basics of face mask and respirator standards, FDA requirements, labeling requirements, lab testing, and more.

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Face Mask standards will no doubt be confusing to the majority of the general public – surgical masks, respirators, ffp3 or N95? In this post we will cover the main face mask types, mask ratings, and what their effectiveness at filtering particles/contaminates can be. We will begin by looking at the different mask types and certification types.

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