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Clinical Barrier and Material Performance

Face-Mask-Fit Testing

Why Perform Fit Testing on Your Face Mask?

Negative-pressure barrier face coverings (e.g., N95 respirators) are devices in which the air is purified by being pulled inwards through a filtration media during breathing. By design the efficacy of these devices relies on the air to pass solely through the incorporated filter. Air leaving through unintended gaps in the respirator’s seal compromises the face covering’s efficacy and may provide unsatisfactory protection.

In light of the recent COVID-19 pandemic and the subsequent increase in the use of facial coverings, ensuring the appropriate fit of face coverings has become not only a matter of personal safety but also public safety. Therefore, the ability of a respirator to fit appropriately on the diverse face shapes and sizes of any given community become critical to that community’s public health. For this reason fit testing of air-purifying, negative-pressure respirators should be conducted by manufacturers to measure how well the respirator seals to faces of different shapes and sizes. This testing can provide confidence to a respirator manufacturer that its respirator fully protects users of various face shapes and sizes.

Types of Fit Testing Available

25-Subject Full-Panel Study

Our most robust study follows the ASTM F3407 method and uses 25 test subjects to evaluate the capability of a face mask’s fit on a variety of face shapes and sizes. This study uses a standardized panel composition described by NIOSH. The exercises and pass/fail criteria of the test are identical to those required by OSHA for respirator users in the professional workplace for protection from hazardous gases and particulates.

10-Subject Data-Analysis Study

This clinical evaluation is a streamlined version of the full 25-subject panel, performed with only 10 study subjects. Unlike the 25-subject version, the 10-subject version does not offer an evaluation of pass/fail criteria; it does, however, provide empirical data on the device’s fit performance across the full standardized panel composition of various face shapes and sizes.

Design Analysis Evaluation

Nelson Labs Bozeman also offers design analysis to support fit efficacy. Our design-analysis service measures key components of the device’s design and evaluates the design’s probability of fit on a variety of face shapes and sizes.

Test Codes

If you would like to inquire about any of the services listed on this page, please submit the quote request form below.

  • CSK318
    Clinical Med Device: Respirator Fit Test

Testing Locations

  • Bozeman, MT, USA

Learn more about our locations and their certifications.

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