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Sovereign America Surgical Mask is intended for use by healthcare personnel to protect both patients and healthcare personnel against the transfer of microorganisms, bodily fluids and particulate material. This is a single use, disposable device, provided non-sterile.

The Sovereign America Surgical Mask is a single use, three-layer, flatpleated surgical mask with ear loops and a nose piece. The device is composed of three layers of nonwoven polypropylene, with the outer layer (Layer 1) and inner layer (Layer 3) being spun-bond nonwoven polypropylene, and the middle layer (Layer 2) being melt-blown nonwoven polypropylene. Layer 1 contains a blue pigment. The device utilizes two elastic ear loops, ultrasonically welded to the mask, to hold the device in place over the users' mouth and nose. The ear loops are polyester spandex elastic, and not made with natural rubber latex. The device also utilizes a malleable nose piece, made of polypropylene coated aluminum wire, to allow the user to fit the device around the bridge of the nose. The mask is provided non-sterile and intended to be a single use, disposable device.

Here's a breakdown of the acceptance criteria and the study information for the Sovereign America Surgical Mask (K201095), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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