ASTM Level 3 Surgical Mask

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. This product has not been FDA cleared or approved.

Made in the USA.

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ASTM Level 3 Surgical Mask

Regular Price $28.00 Sale Price: $10.00 (Save 64%)
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FDA Authorized. Made in the USA in Seattle, Washington. 

When the pandemic began, we asked ourselves how we could help. That simple question led to the transformation of an entire floor at our Seattle facility into a medical PPE production facility. We are proud to make this FDA authorized surgical mask available now. 

Product Details 

• Model OR2159

• Lightweight. Easy on and off design with ear loops to secure fit. 

• Comfortable and non-irritating. Not manufactured with natural rubber latex. 

• Non-sterile 

• Pleated design fits wide variety of faces 

• ASTM Level 3 Performance 

• Full Berry Certificate available 

• All direct and indirect skin contacting materials are biocompatible per ISO 10993. List of body contacting materials in Details & Specs. 

** Final Sale: Sorry, we do not accept returns or exchanges on masks, neck gaiters, or face coverings. **

Available for Bulk Purchasing - Contact Us

 

Intended Use 

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 such clinical conditions where there is significant risk of infection through inhalation exposure. In such clinical conditions, a filtering facepiece (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. 

 

Protection Level

FDA EUA authorized, meets ASTM F2100-2019 Level 3 protection.

Tests Performed and Performance

Bacterial Filtration Efficiency:  ≥99.8%

Particle Filtration Efficiency:  ≥99.8%

Fluid Splash Resistance Pressure: 160 mm Hg

Differential Pressure:  <6.0 mm H2O/cm2

Flammability: Class 1 

Cytotoxicity: Non-Cytotoxic 

Sensitization, Irriation: Non-Irritating and Non-Sensitizing 

 

See full testing results here

Instruction for Use | Fitting & Removal Instructions, visit here

 

Specs


Product :
#283035

Fabric :
Inner Layer - Spunbond Polypropylene Middle Filter Layer - Meltblown Polypropylene Outer Layer - Spunbond Polypropylene Nosepiece - Coated Steel Wire Earloop - Spandex Elastic All direct and indirect skin contacting materials are biocompatible per ISO10993.

Features


Origin
USA

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Guarantee
 

The Infinite Guarantee®

Outdoor Research® gear is guaranteed to perform throughout the lifetime of the product. Get your gear back on track by filing a claim on our Warranty Page

Have a question? Problem? Other request? We’re here to help you find a solution.

Our customer service is waiting for your call at 855-967-8197, on weekdays Monday-Friday between 7am-5pm PST. If you prefer email, you can send your query to info@outdoorresearch.com

Thanks for getting in touch. We can’t wait to get you back outside with your gear.

SKU
283035

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