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Medical Protective Masks is intended to be worn to protect both the patient and healthcare persomel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile.

The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The mask is a single use, disposable device, provided non-sterile in black color.

The provided document (K223686) is a 510(k) Premarket Notification for Medical Protective Masks. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing and material comparisons.

It is crucial to understand that this document describes the regulatory acceptance of a medical mask device, NOT an AI/ML-driven device. Therefore, many of the requested fields regarding AI/ML-specific details (like training/test sets, ground truth establishment for AI, expert adjudication, MRMC studies, and standalone AI performance) are not applicable to this submission. The "study" referenced in the prompt (as proving the device meets acceptance criteria) refers to the non-clinical performance testing of the physical mask, not a clinical or AI-based study.

Here's the information extracted from the document relevant to the performance of the Medical Protective Masks:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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