Biofil Level 3 Surgical Mask Hypoallergenic - Tie-Back

BSMLV3-TB

General Description:

Platinum Health Supply Group’s Range of surgical masks offer affordable and comfortable protection in all environments.

Intended to cover the user's mouth, nose and chin. Provides a physical barrier to prevent pathogenic microorganisms, body fluids, particulate matter, etc. from passing directly.

Product Size:

10pcs per Packet 

50pcs per Box

2000pcs per Carton 

Medical Compliance:

TGA Listing Number – 336077 - This product is listed as a Medical Device Included Class 1

General Features:

  • Meets standard ASTM F2100-11 level 3 (bacterial filtration efficiency – BFE, differential pressure – Delta P)
  • One size fits all
  • Low breathing resistance for maximum comfort and prolonged wear
  • Adjustable nose bridge for a personalised fit
  • Non-sterile
  • Single-use
  • Latex-free
  • Flame resistant
  • 50 masks per box

General Information:

A surgical face mask is a disposable face mask worn over the nose and mouth to help protect against the inhalation of airborne particles and to help prevent the spread of unhealthy airborne particles. Surgical Masks are tested against their Bacteria Filtration Efficiency (BFE), Particular-Filtration Efficiency (PFE), Fluid Resistance Penetration (mmHg) and, Breathability (Delta P).

Unlike other cloth face coverings, a medical face mask is very carefully designed and manufactured to ensure that it remains effective at the prevention of spreading disease but not of minimising any respiratory distress a person may feel due to heavy pollution in the air.

Unlike general 3 Ply Face Masks, Surgical Masks are protective for General Public, Vulnerable Individuals, Medical and Health Care Workers, as well as Front Line Workers.

When wearing these mask’s, the user may limit their exposure to smoke, pollution, concrete/ sawdust, water/ virus particles and some vapours, and Bacteria.

Technical Information:

BACTERIAL FILTRATION EFFICIENCY (BFE)

With a Bacterial Filtration Efficiency (BFE) of greater than 99% for media greater than 3 microns, this mask provides superior protection from potential infection.

BFE is an independent test conducted by approved Independent testing facilities that measure the effectiveness of face mask materials to filter out bacteria.

PARTICULATE FILTRATION EFFICIENCY (PFE)

The super high Particulate Filtration Efficiency (PFE) material filters >99% of particles greater than 0.1 microns. When securely fitted, the mask helps to provide an effective barrier to particulate matter from laser plumes and electrocautery procedures.

PFE measures the effectiveness of the mask material to filter particulate matter.

BREATHABILITY (DELTA P)

The mask design provides excellent breathability and low delta P (≤2.8) ensuring coolness and comfort even when worn for an extended period.

Delta P, also conducted by approved Independent testing facilities, is a test that measures the breathability of mask materials, ranking masks on comfort and coolness for the surgical mask wearer. The lower the figure, the cooler and more comfortable the mask.

FLUID RESISTANCE

The Super Fluid Resistant three-ply layer design provides optimum fluid resistance (120mmHg) – Level 2 and (160mmHg) – Level 3, thus minimising the risk of infection through strikethrough.

Fluid resistance is measured in accordance with ASTM F2101-15 | EN 14683:2014 standard test method for resistance of medical face masks to penetration by synthetic blood at 16.0kPa pressure.

International Standards:

  • ISO 22609:2004 Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)
  • AS/NZS 4381:2015 'Single-use face masks for use in health care'
  • ASTM F2100 - 19 Standard Specification for Performance of Materials Used in Medical Face Masks
  • S. National Institute of Occupational Safety and Health (NIOSH) 42 CFR Part 84 Respiratory Protective Devices (in relation to products labelled with N-, R- and P- classification at 95, 99 and 99.9% filter efficiency)
  • AS ISO 16900.3 2015 Respiratory protective devices - Methods of test and test equipment Determination of particle filter penetration
  • AS NZS 1716:2012 Respiratory protective devices (in relation to products labelled with P1/P2/P3 class filter efficiency)
  • EN 149:2001 + A1 Respiratory protective devices- Filtering half masks to protect against particle – Requirements, testing, marking (in relation to products labelled with FFP1, FFP2 and FFP3 classification)
  • GB 2626-2006 Respiratory protective equipment - Non-powered air-purifying particle respirator (in relation products labelled with the filter element grades types KN and KP 90/95/100 filter elements)
  • ISO 22609: 2004 Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood
  • EN 14683:2019 Medical face masks - Requirements and test methods
  • AS NZS 1715:2009 Selection, use and maintenance of respiratory protective equipment

More Questions:

Still unsure if this product is right for your intended use? Get in contact with one of our Clinical Professionals via the contact us page.



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