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The GOOD High Fluid-Resistant Surgical Mask and the KOEASY High Fluid-Resistant Surgical Mask are 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

The subject device includes six mask models. Each mask is composed of four-layers (outer non-woven layer, support layer, melt blown filter layer, and inner non-woven layer). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The masks are single use, disposable devices, provided non-sterile. These devices are not made from Natural Rubber Latex.

The provided text is a 510(k) summary for surgical masks, not an AI/ML-enabled medical device. Therefore, the information requested in your prompt regarding AI/ML performance metrics, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this document.

However, I can extract the acceptance criteria and non-clinical study results for these surgical masks, as presented in the document.

Acceptance Criteria and Reported Device Performance (Non-Clinical Testing for Surgical Masks)

The non-clinical tests were conducted to verify that the proposed device met design specifications and complied with relevant standards. The tests align with ASTM F2100 Level 3 barrier requirements.

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