Demonstration of a reusable mask in a tubular design that provides universal fit and protection from respiratory hazards

Background: There is a well-documented need for a reusable, high-performing face mask for use by the public as a barrier to respiratory hazards.

Objective: This utility validation study sought to assess the functionality of a tubular-shaped, textile based solution to enable the simple manufacture of a reusable face mask designed to minimize leakage and to achieve high levels of community protection from respiratory hazards.

Methods: We used a mechanistic approach to design, develop, and combine engineered components into an integrated tubular solution. To ensure the desired features were optimized when integrated, after reprocessing we tested the entire mask, as worn, for physiological impact, comfort, filtration efficiency, and leakage. For several features, the novel design and tubular shape required in-house design and manufacture of new test equipment. We tested fabrics, prototypes, and reprocessing protocols in-house and with academic partners. Independent testing for certain features was available (e.g., EN14683 Medical Face Masks, ASTM F3502-21, Standard Specification for Barrier Face Coverings) and was used to confirm performance.

Results: The tubular shape, special seals, unique harness, and three-layers of fabrics with distinct functions and composition work together to minimize leaks and ensure durability after repeated laundering. In-house testing indicated that designing a textile-based, tubular-shaped face mask optimized for source control with minimized leakage also resulted in wearer protection properties, even after hundreds of laundering cycles. Independent testing of one filter choice (Filter B) after 50 laundering cycles confirmed low breathing resistance (4.9 mm H2O/48 Pa) and high filtration efficiency (96%) to ASTM F3502-21.

Conclusion: This utility validation study concludes that a reusable, tubular-shaped, textile-based face mask is capable of a universal fit as well as filtration efficiency and breathability performance levels that are similar to those for a disposable filtering facepiece respirator.