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The 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. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

The Surgical Face Mask is 4 ply Flat Pleated type mask, utilizing ear loops for wearing, and it has nose band design for fitting the face mask around the nose. The Surgical Face Mask is manufactured with four layers. The first and second layers are made of polypropylene (PP) non-woven fabric with green coloration. The third layer has filtration function and is made of polypropylene (PP) melt-blown non-woven fabric. The fourth layer (inner layer) contacting with face is made of polypropylene (PP) non-woven fabric without color. The functions of the four layers are as follows, 1st Layer: Water-repelling, non-woven fabric. Prevents droplet and spray penetration. 2nd Layer: Water-repelling, non-woven fabric. Prevents droplet and spray penetration. 3rd Layer: Electrostatic-induced melt-blown polypropylene, blocks dust and microbes. 4th Layer: PP non-woven fabric, provides soft feel and reinforces spray and droplet protection. The Surgical Face Mask is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon. The nose band, made of steel wire coated with Polyethylene resin, contained in the subject device is in the layers of face mask to allow the user to fit the face mask around their nose. The Surgical Face Masks are sold non-sterile and are intended to be singleuse. The size of the face mask is 175 mm * 95 mm.

This document describes the non-clinical performance testing of the "Surgical Face Mask" manufactured by Taiwan Comfort Champ Manufacturing Co., Ltd. (K212863), to demonstrate its substantial equivalence to a legally marketed predicate device (K201549).

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

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