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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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EN 14683 Harmonized Standard. The EN 14683: Medical Face Masks is a harmonized standard under the MDD, and provides requirements and test methods for medical face masks. In general, the EN 14683 standard classifies the masks into three categories based on their performance. Here we list an overview of those three types of masks:

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Respirators meet the CDC Guidelines for Mycobacterium tuberculosis exposure control. They are certified by NIOSH as N95's and designed to provide a secure face-to-respirator seal. This seal helps reduce the wearer's exposure to airborne particles, making them appropriate for protection from laser and electrocautery plume.

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This standard defines the respirators as filtering facepieces and classifies them into three categories: FFP1, FFP2, FFP3, based on the particle-filtering efficiency of the masks. The higher the number is, the more protective a mask can be to the users in terms of its particle-filtering efficiency.

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