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The Velguard Surgical Face Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are 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 nonsterile.

The Velguard Surgical Face Mask is a single use, three pleated, flat-folded rectangular masks with ear loops and adjustable nose wire. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The inner spun-bond polypropylene layer uses no colorant. The outer spun-bond polypropylene layer uses a blue colorant. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene coated zinc wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Velguard Surgical Face Mask:

The document is an FDA 510(k) summary for the Velguard Surgical Face Mask (K210761). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through a comprehensive clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

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