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The PM Excellence SEQUR 100 Surgical Face Masks (for single use only) are indicated as protective nose and mouth covering for healthcare workers and patients. These face masks are intended for use in infection control practices as well as any medical or surgical procedure or situations where there is a risk of exposure to microorganism, body fluid, and particulate materials.

PM Excellence SEQUR 100 Surgical Face Mask (light blue) for single use only, are pleated 3-ply masks that consist of the following materials: hydrophobic nonwoven PP (polypropylene) spunbond 35 gsm, 17.5cm, light blue (outer layer); nonwoven PP (poly propylene) spunbond 30gsm, 19.5cm, white (inner layer); and nonwoven PP (polypropylene) meltblown 30gsm, 17.5cm, white (middle filter layer). The PM Excellence SEQUR 100 Surgical Face Mask Light Blue also utilizes soft, latex-free elastic earloops and malleable wire nose piece.

This document describes the performance testing for the PM Excellence SEQUR 100 Surgical Face Mask. This is a medical device, and the testing outlined is to demonstrate substantial equivalence to a predicate device, as required for a 510(k) submission to the FDA. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the a set of standardized performance tests that surgical masks must pass, and the results of those tests for the new device.

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1. Table of Acceptance Criteria and Reported Device Performance

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