Ochsner Health is a system that delivers health to the people of Louisiana, Mississippi and the Gulf South with a mission to Serve, Heal, Lead, Educate and Innovate.
The Ochsner Windowed Mask is a community protection mask that features a clear window that provides visibility of the wearer's lower face. The Windowed Mask project came about in response to the needs of patients with hearing, speech, and cognitive impairments for whom the ability to see the mouth is critical. These patients faced unique challenges as the emergence of COVID-19 necessitated the use of face masks by clinicians and caregivers. Ochsner turned to innovationOchsner - it’s bioengineering and innovation lab - to develop a solution.
Through initial pilots of early prototypes, myriad other uses for the Windowed Mask emerged throughout Ochsner, most recently in the NICU, where the mask has provided newborns with their first view of parents’ faces at a critical time in their development when babies start associating mouth forms and facial expressions with language.
Orientation
Wash and Care Instructions
De-Fogging Instructions
MATERIALS
Material 1 96% Cotton 4% Spandex
Material 2 Clear Vinyl: 100% Polyester
LATEX FREE
MADE IN THE USA
DISCLOSURES
Warning: Use at your own risk. DO NOT USE in a clinical setting where the infection risk level through inhalation exposure is high. This product is NOT a surgical mask. This product is NOT Personal Protective Equipment (PPE) and should not be used to meet a professional healthcare facility’s obligations to protect workers against infectious disease hazards.
This product has not been FDA cleared or approved. The product has been authorized by FDA under an EUA for use as source control by the general public as well as by HCP in healthcare settings as to help prevent the spread of infection or illness during the COVID-19 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. For more information see: https://www.fda.gov/media/137121/download