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Surgical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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(s), provided non sterile.

The Surgical face mask is single use, three-layer, flat-pleated style with ear loops/ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the tie on are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics.

The model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.

The model of proposed device, ear loops, is held in place over the uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.

The ear straps/ear loops are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Poly Ethylen. The Surgical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.

This document describes the acceptance criteria and the study proving a surgical face mask meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

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