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This product is indicated for infection control practices in the health care industry. When worn properly, The Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.

The Medical Surgical Mask is flat style mask, model MP002-5 utilizing tie-on and model MP002-6 utilizing ear Loops way for wearing, and they all has nose clip design for fitting the face mask around the nose. The Medical Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of polypropylene melt-blown. The color of the outer layer is blue (colorant: Copper phthalocyanine/ CAS number: 147-14-8) The models of mask are ear loops and tie-on, masks are held in place over the users' mouth and nose by two high elastic spandex ear loops or bands welded to the face mask. The nose clip contained in the Medical Surgical Mask is in the layers of face mask to allow the user to fit the mask around their nose, which is made of plastic environmental protection line. The Medical Surgical Mask are sold non-sterile and are intended to be single use, disposable device. The dimension of the tie-on band (Model: MP002-5) is 25cm±2cm1cm±0.2cm (LW), and the dimension of the ear loop (Model: MP002-6) is 17cm±0.5cm0.4cm(LW). What's more, the dimension of the nose clip (Model: MP002-5, MP002-6) is 90mm2.5mm 0.45mm (LWH).

This document is a 510(k) summary for a Medical Surgical Mask (Models: MP002-5, MP002-6). The acceptance criteria and performance data provided relate to the physical and performance characteristics of the mask itself, rather than a diagnostic device with an AI algorithm. Therefore, many of the requested points regarding AI model evaluation (like sample size for test/training sets, expert consensus, MRMC studies, standalone performance) are not applicable to this submission.

Here is the information that can be extracted from the provided document, tailored to the type of device (a surgical mask):

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

The document compares the subject device to a predicate device and also lists specific performance test results against established standards.

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