BioMask Medical Face Mask outer box of 25

BioFriend's revolutionary, patented technology traps and kills bacteria and viruses on contact AND allows you to breathe normally:
• Traps and kills 99.9% of harmful germs
• Superior breathability & comfort
• Self-sanitizing for ALL-DAY WEAR
• Reduces cross-contamination of hands and surfaces
• Standard and small sizes
*Kills germs including those that cause Infl uenza A, Bird Flu, common colds, measles, MRSA, pneumonia, SARS and tuberculosis. BIOMASK BioFriend traps microbes by mimicking the sites on human cells to which they normally attach, then, destroys them by disrupting their surfaces (viruses) or cell walls (bacteria).
Replace after 8 hours of active wear or earlier, if damaged or soiled with blood or bodily fluids.

How does the BioMask work? What is the active ingredient?
In general, the BioFriendTM textile CAPTURES pathogens by mimicking the sites
on human cells to which they normally attach, and DESTROYS them by
disrupting their surfaces (viruses) and cell walls (bacteria).
Many viruses, including influenza viruses, are known to bind to human cells through
oligosaccharides attached to cell membrane glycolipids or glycoproteins, and,
specifically, to a terminal sialic acid residue on a surface oligosaccharide of the cell
membrane. The binding agent in the BioFriendTM textile mimics the binding action of
sialic acid on influenza viruses. This technique is often called ‘molecular mimicry.'
A safe component approved by the FDA functions as the binding agent. This
component creates a negative charge at the molecular level, attracting microbes
through electrostatic forces. Copper and zinc ions then kill the microbes. These metal
ions kill pathogens by disrupting their viral envelope and bacterial walls, as well as by
creating an ion imbalance in the bacteria or virus that inhibits normal metabolism.
3. Can the microbe-killing mechanisms or ingredients harm me? If the BioMask
can kill germs so effectively, why doesn't it harm me?
The BioMask is deemed safe when used as intended. It has met or exceeded ISO
standards for biocompatibility. See FAQ 4 (below). The anti-microbial components
Page 2 of 5. BioMask FAQs. © Filligent (HK) Limited 2009. All rights reserved. Patents pending. Please see the end of this
document for important information relating to these FAQs.
have been approved for biomedical use by the FDA in sutures and contact
lenses, for example. Copper and zinc are essential to human health and are an
important part of a human being's daily nutritional intake, because they contribute to
the function of numerous essential processes in the body, including wound healing.
Multi-cellular higher organisms, such as humans, possess mechanisms which bind or
transport away copper and zinc ions. Single-cell organisms, such as bacteria and
viruses, don't possess such efficient mechanisms and are easily killed by miniscule
amounts of these compounds. Therefore, copper and zinc are very toxic to
bacteria and viruses, but not to humans.
4. What tests have been conducted to ensure that the BioMask is safe for humans?
The BioMask achieved CE certification on 13 February 2009. Filligent has met or
exceeded the requirements of CE certification relating to human safety for a
device of this kind. Independent studies of the BioMask confirm that, when assessed
in terms of all the major routes of exposure, oral, dermal and inhalation, the active
ingredients used in the BioMask cause no harmful effects on isolated human cells.
Pursuant to CE requirements, the BioMask has been tested for dermal
biocompatibility following internationally recognized standards set out in
ISO10933: Biological Evaluation of Medical Devices. Tests were conducted to
evaluate cytotoxicity to cells, skin irritation on contact, and skin sensitization after
repeated contact. No cytotoxicity, irritation or incidence of sensitization was
observed.
For further technical details, see Summary of Independent Laboratory Testing.
5. What is the CE mark and the significance of CE certification?
The CE (Conformité Européenne) mark is a conformity mark required to market
certain products in the European Community. The CE mark is mandatory for certain
product groups to indicate conformity with the essential health and safety
requirements set out in European Directives. The BioMask has achieved
certification pursuant to the European Community's Medical Devices Directive
93/42/EEC, meaning that Filligent has met the stringent EU requirements for
design, efficacy and safety for this type of medical device.
6. Can such an anti-microbial product reduce my or my family's immunity?
No. The immune system is inside the body and is activated only when pathogens
enter inside the body. The BioMask keeps germs outside the body and kills germs
before they enter the body. Therefore, it has no effect on the body's immune
system.
7. Can the BioMask create resistant germs?
Germs can only develop defense mechanisms (i.e., resistance mutations) when
proliferating inside the human body in the presence of a drug. The BioMask keeps
the germs outside the body and kills microbes before they can enter the body.
Therefore, use of the BioMask does not result in microbes developing resistance
to either the BioMask or drugs.