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Dong Hai Xiang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. adult only. The device is disposable and is indicated for single use. The device is not provided sterile

The Dong Hai Xiang Surgical Masks are composed of 3-layers and are flat-pleated provided blue color, the mask materials consist of an outer layer (polypropylene), Inner layer (polypropylene), Middle Layer filter (Polypropylene Melt-blown), Ear-loops (Spandex + Nylon, Ear Loops way for wearing) and Nose piece (a Polyethylene + Galvanized Iron wire nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face). The Dong Hai Xiang Surgical Masks are single use, adult only, disposable device, provided non-sterile.

This document is a 510(k) Summary for the Dong Hai Xiang Surgical Mask, outlining its safety and effectiveness compared to a predicate device. It details performance criteria typical for surgical masks rather than a complex AI-driven medical device. Therefore, many of the requested elements for an AI/ML device study (e.g., sample size for training set, number of experts for ground truth, MRMC studies) are not applicable here.

Here's an analysis based on the provided text, focusing on the acceptance criteria and the study proving the device meets them:

Device: Dong Hai Xiang Surgical Mask
Type: Surgical Apparel (Class II Medical Device)

1. Table of Acceptance Criteria and Reported Device Performance

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