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The Disposable Medical Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop 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 Disposable Medical Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical Surgical Masks 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 proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond non-woven, and the middle layer is made of Melt-blown non-woven fabric.

The Disposable Medical Surgical Masks is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with Polyurethane fiber and Nylon.

The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PE and iron wire.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

The proposed device(s) are meet the Level 3 Barrier requirements per ASTM F2100-19.

This document is a 510(k) Premarket Notification for a medical device (Disposable Medical Surgical Masks). It is a regulatory submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to the predicate device based on non-clinical performance and specifications.

Therefore, many of the typical acceptance criteria and study details relevant to AI/ML-based medical devices (like MRMC studies, expert adjudication, separate training/test sets for AI, human-in-the-loop performance, etc.) are not applicable to this document, as it describes a physical medical device (surgical masks) and its performance based on standardized material testing.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on meeting established industry standards for surgical masks, primarily ASTM F2100-19 for medical face mask materials, and other related standards (ISO 10993 for biocompatibility, ASTM F1862 for fluid resistance, etc.). The reported device performance is presented in comparison to these standards and a predicate device.

Table of Acceptance Criteria and Reported Device Performance (Summary from Section 6 and 7):

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