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The DISPOSABLE 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 the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.

The DISPOSABLE FACE MASK is flat pleated style mask, utilizing ear loops way for wearing, and they all has nose clip design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer facing layers are made of spunbonded non-woven, and the middle layer is made of melt-blown non-woven 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 face mask. The elastic ear loops are not made with natural rubber latex. The nose clip contained in the proposed device(s) is in the layers of face mask to allow the user to fit the mask around their nose, which is made of PE coated Tin-plate wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The provided document describes the safety and effectiveness of a DISPOSABLE FACE MASK (Models: TX-005, TX-006) by Jiujiang Taixin Technology Co., Ltd. It is a 510(k) premarket notification, indicating a comparison to a legally marketed predicate device (K202424) rather than a de novo approval requiring extensive clinical trials. Therefore, the "study" referred to is a series of non-clinical performance and biocompatibility tests conducted according to established international standards.

Here's a breakdown of the requested information:

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

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