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Face Mask - US

FilterPore™ Polyurethane Foam

Woodbridge INOAC Face Mask incorporates INOAC proprietary design, validated in Japan with industrial filtration foam technology. This mask construction creates a comfortable foam outer layer and contact layer mask, compatible with a variety of protective eyewear protection, inner barrier material, and nose clip.

For use when FDA cleared masks are unavailable.(under FDA Product Code QKR). *

Not Recommended for Use

  • In a surgical setting or where significant exposure to bodily liquid or other hazardous fluids may be expected.
  • In a clinical setting where the infection risk level through inhalation exposure is high.
  • In the presence of a high-intensity heat source or flammable gas.

Does Not Provide

  • Any antimicrobial or antiviral protection, whatsoever.

Body Contacting Material

  • Polyurethane Foam

Regions:

NOTICE: 

The product has not been FDA cleared or approved.

The product has been authorized by FDA under an Emergency Use Authorization for use as source control by the general public as well as by Health Care Professionals in healthcare settings as to help prevent the spread of infection or illness during the COVID19 pandemic.

This product is authorized 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.

* FDA QKR Product Classification website