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The Disposable medical masks are intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.

The Disposable medical mask is flat pleated type mask, utilizing ear loops way for wearing, and they all have nose clip design for fitting the facemask around the nose. The Disposable medical mask is only one model: WSKZ-001 and the color is blue. The Disposable medical mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, only the outer layers' color is blue (colorant: Pigment Blue, CAS number: 147-14-8), and the middle layer is made of melt blown fabric. Ear loops, which is held to cover the users' mouth and nose by two Ammonium nylon elastic bands ultrasonic welded to the Disposable Medical Mask. The elastic ear loops are not made with natural rubber latex. The nose clip contained in the Disposable medical mask is in the middle layer of Disposable medical mask to allow the user to fit the Disposable mask around their noses, which is made of Polypropylene and metallic iron. The Disposable medical mask is sold non-sterile and is intended to be single use, and the intended environment is professional healthcare facility environment. The shelf life of each Disposable medical mask is 2 years. The dimensions of each Disposable medical mask are length 175mm and width 95mm. The dimension of nose clip is length 100mm, and the ear loop is length 170mm.

The provided text describes the acceptance criteria and performance data for a medical mask (K203388) seeking FDA clearance, primarily through comparison to a predicate device (K153409).

Here's the breakdown of the information requested:

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

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