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The following Liberty Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These are single use, disposable device(s) provided non-sterile.

The LM Surgical Masks are white, single use, three-layer, pleated masks that come in 2 models: LM Surgical Mask Level 3 & LM Surgical Mask Level 2. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene. The masks are held in place over the users' mouth and nose by either two elastic ear loops, welded to the facemask. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose. The nose piece is made of polypropylene coated steel wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

Here's a breakdown of the acceptance criteria and study information for the "LM Surgical Mask Level 2" and "LM Surgical Mask Level 3," based on the provided FDA 510(k) summary:

This document describes a medical device clearance for surgical masks. These devices are typically evaluated through bench testing (non-clinical) to meet specific performance standards, rather than full clinical trials with patient outcomes. Therefore, most of the questions relating to clinical study design (experts, adjudication, MRMC, human-in-the-loop, training set details) are not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance:

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