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COVID-19 FDA Exemptions Due to Mask Shortages in the United States. Due to the current situation, the FDA is currently accepting the import N95 respirators that aren’t approved by NIOSH, but which are approved by authorities in the EU, China, Japan, Korea, Mexico, Australia, or Brazil.

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KN95 Face Mask Respirator - ginifab

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Based on this comparison, it is reasonable to consider KN95(China GB2626-2006), KF94 (Korea KMOEL - 2017-64) as “equivalent” to N95 (United States NIOSH-42CFR84) and FFP2 (Europe EN 149-2001) respirators, for filtering non-oil-based particles such as those resulting from wildfires, PM 2.5 air pollution, volcanic eruptions, or bioaerosols (e.g. viruses).

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Key Differences Between Respirators and Masks April …

Key Differences Between Respirators and Masks Surgical Masks: • Are cleared by the FDA for use as a surgical mask. • Do not have the word NIOSH and the approval type (i.e. N95) printed on the product. • Are not designed to protect your lungs from airborne hazards. • Are typically donned for a specific procedure and disposed of afterward.

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