Simulated workplace protection factor study of a quarter-facepiece elastomeric respirator.

The assigned protection factor (APF) for quarter-facepiece respirators is currently 5, based on fit test data from the 1970s with models no longer commercially available. The goal of this project was to evaluate the respirator fit capability of a NIOSH-approved N95 quarter-facepiece elastomeric respirator with a gel-based facial seal design (Envo Mask by Sleepnet Corporation). Human subjects were recruited from healthcare and the general population to satisfy a 25-member NIOSH bivariate panel. Subjects were fit tested with a fast fit protocol using a TSI Portacount Model 8038 in the N95 mode. Second-by-second measures of fit were then collected while subjects performed a 30-min series of simulated healthcare activities. Subjects completed a short comfort questionnaire. The median (5th, 95th percentile) fit factor was 188 (48, 201). Simulated workplace protection factors (SWPFs) had a median (5th, 95th percentile) of 181 (94, 199) (data truncated at 200) and 570 (153, 1508) (non-truncated data). Subjects ranked inhalation and exhalation as "easy" with average scores of 5.0/6.0 and 5.2/6.0, respectively. The facepiece was ranked between slightly comfortable and comfortable (4.8/6.0) and the harness as comfortable (5.0/6.0). Most users agreed (5.2/6.0) that the mask was stable on their faces. The 5th percentile SWPF of 95 supports an APF of at least 10 for this quarter-facepiece elastomeric respirator, similar to the APF for half-facepiece respirators. This study supports increasing the APF for quarter-facepiece respirators, a class that has been largely ignored by manufacturers for the past 40 years. A lightweight, low profile, reusable quarter-facepiece respirator is an effective option for healthcare and other worker protection during a pandemic and similar situations.