ASTM Level 3 Surgical Face Mask | Model OR2159

Indications for use:

  1. The Outdoor Research Surgical Mask is intended to be used by operating room personnel during surgical procedures to reduce transmission of and exposure to certain microorganisms, airborne particles and liquids. It is a loose-fitting device worn over the user’s nose and mouth that creates a physical barrier from potential contaminants in the immediate environment and may be use to protect the sterile field. This device alone does not offer protection to the eyes or rest of face. Surgical masks are not intended to be used more than once and are disposable. If the mask is damaged or soiled, or if breathing through the mask becomes difficult, it should be removed, discarded of safely, and replaced.
  2. Thoroughly inspect the surgical mask prior to use. If any components, including the filter material, the elastic earloops, or the nosepiece are damaged or missing, do not use and dispose of properly. Damage may include missing components, tears or holes in the filter material, or other issues which noticeably have a negative effect on performance.
  3. Immediately leave the contaminated area and seek help if dizziness, difficulty breathing, or other deleterious conditions arise.
  4. This is a single use surgical mask. It may be used until it becomes difficult to breathe through, damaged, or is thought to be contaminated in any way. In a healthcare setting, it should be discarded after each examination or procedure. Given the Public Health Emergency PPE shortage, follow current government and facility guidance and regulations.
  5. Given current CDC guidance, it is recommended that this product is not for use by the general public in order to ensure supply for healthcare workers.
  6. A surgical mask is not intended to replace a surgical respirator and does not protect against pathogenic biological airborne particles. This device should not be used in aerosol generating procedures or any clinical conditions where the risk of infection through inhalation exposure is high. 

Fitting Instructions:

  1. Pull the earloops to the outside of the mask.
  2. With the wire nosepiece up, and downward-facing pleats outward, pull the elastic earloops behind the ears. The mask should be secure over the nose and mouth.
  3. Press the nosepiece so it conforms to the bridge of the nose and pull the mask down to wrap under the chin.

Removal Instructions:

  1. Without touching the surgical mask filter media, remove the earloops from behind the ears and the mask from the face. Be mindful not to the touch face or mask filter as hands may be contaminated. Dispose or store in accordance with current government and facility guidance and regulations.

Outdoor Research Surgical Face Mask

Model #OR2159

Product Details:

  • FDA authorized as a surgical mask under EUA
  • Lightweight, easy don/doff, ear loop secured
  • Comfortable and non-irritating, latex free
  • Easy to breathe through
  • Pleated design fits wide variety of faces
  • Highest ASTM level of fluid resistance
  • Immediately available in white color
  • Light blue color coming soon
  • Box count of 50, carton count of 2000
  • Full Berry Certificate available

Protection Level:

FDA EUA authorized, meets ASTM F2100-2019 Level 3 protection and >99% virus filtration efficiency.

     Tests Performed Test Method Spec Performance
Barrier Tests Bacterial Filtration Efficiency ASTM F2101 ≥98% ≥99.8%
Barrier Tests Particle Filtration Efficiency ASTM F2299 ≥98% ≥99.5%
Barrier Tests Viral Filtration Efficiency(Optional, not required) Modified ASTM 2101 N/A >99%
Barrier Tests Fluid Splash Resistance Pressure ASTM F1862 160 mm Hg 160 mm Hg
Physical Tests Differential Pressure EN 14683 Annex C <6.0 mm H2O/cm2 3.5 mm H2O/cm2
Safety Tests Flammability 16 CFR Part 1610 Class 1 Class 1

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