NIOSH Investigation of 3M Model 8000 Filtering Facepiece Respirators

NIOSH investigators assessed sample units of the 3M Model 8000 FFRs received from the CDPH stockpile in order to check for any non-compliance with the NIOSH approval requirements for filtration efficiency and airflow (breathing) resistance. The goal was to determine if the respirators were manufactured in accordance with the NIOSH-approved quality assurance plan and had appropriate construction and workmanship. The investigation also evaluated respirator performance when fit tested on a panel of human test subjects representing a variety of facial dimensions. The evaluation revealed that the performance tests, reviews of quality assurance records, and material and workmanship inspections were in compliance with applicable approval requirements. Additionally, sample respirators had fit test passing results on 22 and 25 of the 40 subjects in two trials. The NIOSH investigation determined that the fit test pass rate reported at the various facilities of a California healthcare organization did not result from any defect in the units’ characteristics on which the product was certified.

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