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The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.

The medical face mask is designed and manufactured by Haian Medigauze Co., Ltd . It is non-sterile and for single use. The medical face mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elastic ear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device, which is made from steel wire, allows the user to fitthe face mask around their nose. The product is level 1 according to ASTM F2100-19.

This document describes the premarket notification (510(k)) for a Medical Face Mask, focusing on its substantial equivalence to a legally marketed predicate device. The information provided is for a physical medical device (a face mask) and not an AI/ML-driven device. Therefore, many of the requested details about AI model performance, training sets, ground truth establishment by experts, adjudication, and MRMC studies are not applicable to this document.

However, I can extract and present the acceptance criteria and the study results for this specific medical device.

Device: Medical Face Mask (K212471)
Predicate Device: Surgical Face Masks (Ear loops and Tie-on) (K160269)

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are "Pass" for all tests, with specific quantitative thresholds where applicable. The reported device performance is that all tests met these criteria.

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