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The MASC Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.

The MASC Surgical Mask is a three-ply, nonwoven, flat pleated mask. The MASC surgical mask consists of an outer layer (polypropylene spun-bond, blue), a middle filter layer (Polypropylene melt-blown, white), and an inner layer (Polypropylene spun-bond, white). The three layers of the mask body are collated with ultrasonically welded edges and comes in two models, an ear- loop model (NFR03U-01A) and a tie-on model (NFR03U-01B). The polyester spandex blend ear loops or polypropylene tie-on band are ultrasonically bonded to the sides of the non-filtration area of the mask to secure the mask over the user's mouth, nose and chin. A malleable polyethylene coated wire nosepiece is placed within the top binding for comfort and individualized fit over the nose. The MASC Surgical Mask is a single use, disposable, nonsterile device which conforms to ASTM F2100-19 Level 3. This device does not contain any natural rubber latex or fiber glass materials.

This document is a 510(k) Premarket Notification for a surgical mask (MASC Surgical Mask, K211984). It's a regulatory submission to the FDA, not a study report for an AI/ML medical device. Therefore, the information requested about acceptance criteria and study proving device meets acceptance criteria, specifically related to AI/ML devices, cannot be fulfilled from this document.

However, I can extract information regarding performance testing for this physical medical device (surgical mask) as outlined in the provided text.

Here's the relevant information from the document related to the MASC Surgical Mask's performance:

1. A table of acceptance criteria and the reported device performance

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