IFU-0101

Rev.0

Published 2020-08-11

ASTM Level 3 Surgical Face Mask | Model OR2159

Intended Use:

  1. The Outdoor Research Surgical Mask has been authorized by FDA under an EUA for use in healthcare settings by healthcare personnel (HCP) as personal protective equipment (PPE) to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic.

Outdoor Research Surgical Masks have not been FDA cleared or approved. Outdoor Research Surgical Masks are authorized by the FDA only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner. They are intended to be used when FDA-cleared surgical masks or FDA cleared or authorized respirators are not available. The Outdoor Research Surgical Mask is a loose-fitting device worn over the user’s nose and mouth. Surgical Masks may be effective in blocking splashes and large-particle droplets; however, because of the loose fit between the surface of the surgical mask and the user’s face, leakage can occur around the edge of the mask when the user inhales. Therefore, a surgical mask may not provide the user with a reliable level of protection from inhaling smaller airborne particles and is not considered respiratory protection. For this reason, surgical masks are not recommended for use in aerosol generating procedures and any clinical conditions where there is significant risk of infection through inhalation exposure. In such clinical conditions, a filtering facepiece respirator (such as an N95 respirator) with a tight fit is recommended to provide a more reliable level of respiratory protection against pathogenic biologic airborne particulates.

Instructions for Use:

  1. 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 mask filter media, or other issues which noticeably have a negative effect on performance.
  1. Immediately leave the contaminated area and seek help if dizziness, difficulty breathing, or other deleterious conditions arise.
  2. This is a disposable, 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.
  3. A surgical mask is not intended to replace FDA-cleared surgical masks or FDA-cleared or authorized respirators and does not protect against pathogenic biological airborne particulates. 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 in accordance with current government and facility guidance and regulations

Outdoor Research Surgical Face Mask Model #OR2159

Product Details

  • This product has not been FDA cleared or approved.
  • This product is authorized by the FDA as a surgical mask under EUA for use in healthcare settings by HCP as PPE to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic.
  • Lightweight, easy don/doff, ear loop secured
  • Comfortable and non-irritating, not made with natural rubber latex
  • Non-sterile
  • Pleated design fits wide variety of faces
  • ASTM level 3performance
  • Immediately available in white color
  • Light blue color coming soon
  • Box count of 50, carton count of 2000
  • Full Berry Certificate available
  • All direct and indirect skin contacting materials are biocompatible per ISO 10993. List of body contacting materials below.
  •  

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% ≥99.8%
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 <6.0 mm H2O/cm2
Safety Tests Flammability 16 CFR Part 1610 Class 1 Class 1
Biocompatibility Cytotoxicity ISO 10993-5 Non-Cytotoxic Non-Cytotoxic
Biocompatibility Sensitization, Irritation ISO 10993-10 Non-Irritating and Non-Sensitizing Non-Irritating and Non-Sensitizing

List of Direct and Indirect Body Contacting Materials:

Component

Inner layer

Middle Filter layer

Outer layer

Nosepiece

Earloop

Material


Spunbond Polypropylene

Meltblown Polypropylene

Spunbond Polypropylene

Coated Steel Wire

Spandex Elastic


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