Regulatory Compliance

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Canadian Regulatory Compliance


Health Canada Grants Nexera Medical a Device Establishment License for the SpectraShield™ 9900 Antimicrobial Respirator Mask
Maximum Respiratory Protection provided by the SpectraShield™ 9900 Antimicrobial Respirator Mask with "Dual Action" protection:
  • Continuously Kills Bacteria and Inactivates Viruses
  • Exceeds 99% plus filtration efficiency against Bacteria and Viruses
  • Kills MS-2, MRSA, Haemophilus influenza, Legionella pneumophila and Streptococcus pyogenes, TB.
  • Inactivates SARS, Bird Flu (H5N1), Influenza A, Human Rhinovirus, Adenovirus.

The SpectraShield™ 9900 Antimicrobial Respirator Mask" provides:
  1. Superior filtration of N99 performance
  2. Continuous antimicrobial protection against viruses and bacteria.
  3. 99.9% filtration efficiency against viruses and bacteria as small as .03 microns.
  4. Exceeds the U.S. Center for Disease Control ("CDC") ( www.cdc.gov ) and World Health Organization ("WHO") ( www.who.int/en ) guidelines for protection against infectious microbial threats such as Avian Influenza, SARS and Tuberculosis.
  5. Patented proven technology incorporating a U.S. Environmental Protection Agency ("EPA") approved antimicrobial agent which is embedded into the fiber for enhanced protection.
  6. Fluid Resistance which reduces the risk and meets the requirements for ASTM Fluid Resistance. ("Resistance of Medical Face Masks to Penetration by Synthetic Blood" - at a minimum pressure of 120 mm Hg.)
  7. Reduces mask odor caused by bacterial growth.
  8. Continuously self-sanitizes itself for extended use.
  9. Natural nontoxic antimicrobial agent is safe for wear.