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Phyziofit Medical Surgical Masks are 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 a single use, disposable device(s), provided non-sterile.

The proposed device(s) are Blue color (colorant: Pigment blue 15:3/CAS No. 147-14-8), and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose clips design for fitting the facemask around the nose. The proposed device(s) are manufactured with three layers, the outer layer is made of polypropylene non-woven fabric, the middle layer is made of melt blown non-woven fabric and the inner layer is made of absorbent nonwoven fabric.

The model of proposed device, ear loops, is 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 clips contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of PP plastic material.

The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The provided text describes the acceptance criteria and the study conducted for the Phyziofit Medical Surgical Mask (K201868).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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