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The Protective Face Mask for Medical Use is intended to worn by the healthcare personnel during procedure to protect both the patient and the healthcare personnel from the 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(s), provided non-sterile/sterile.

The Protective Face Masks for Medical Use are flat-folded masks are three layers of materials consisting of polypropylene spun-bond (outer layer and inner layer), polypropylene melt-blown (middle layers). The masks contain a conformable nose piece enclosed in a binding tape welding the top edge to conform to the contours of the face. In addition, the masks contain an ultrasonically welded, elastic ear loops not made with natural rubber latex, to secure the masks in place on the wearer. The masks are offered in white. The Protective Face Masks for Medical Use are single use, disposable device, provided non-sterile/sterile.

The provided document is a 510(k) premarket notification for a "Protective Face Mask for Medical Use." It assesses the substantial equivalence of the proposed device to predicate devices. The study conducted is a non-clinical performance test, not a study involving human readers or AI.

Here's the breakdown of the requested information based on the provided text:

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

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The Protective Face Mask for Medical Use is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The 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 Protective Face Mask for Medical Use is a single use, two-panel, flat-folded mask with ear loops and nose piece. The mask is designed into a C-shape when flat-folded. The C-shaped design allows for an expanded chamber for the mask in use. The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The elastic ear loops are made of spandex and polyester, which are welded to the facemask to hold the mask in place over the users' mouth and nose. The elastic ear loops are not made with natural rubber latex. The nose piece is a malleable aluminum strip covered with sponge, which is welded to the facemask top edge to allow the user to fit the facemask around their nose. The mask is a single use, disposable device, provided non-sterile in white color.

This document is a 510(k) Premarket Notification submission for a medical device, specifically a "Protective Face Mask for Medical Use." It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a "Performance testing" table (Table 2) that directly addresses this point.

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