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

The Surgical Face Masks (Non-sterile) are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is blue polypropylene (PP) master batch.

The inner layer and outer layer of the mask are made of spun-bonded non-woven fabric (polypropylene), the middle layer is made of polypropylene melt-blown non-woven fabric. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of galvanized iron wire coated by PE.

The Surgical Face Mask (Non-sterile) is sold non-sterile and are intended to be single use, disposable devices.

The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.

The document provided is a 510(k) Pre-market Notification for a Surgical Face Mask (Non-sterile). It outlines the non-clinical testing performed to establish substantial equivalence to a predicate device. This type of submission relies on performance testing against established standards rather than clinical studies for device functionality.

Here's a 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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