Search Results

The Banyan USA Surgical Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganism, body fluids, and particulate materials. This face mask 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 Banyan USA Surgical Mask is composed of three-layers which are flat-pleated and ultrasonically welded together at the edges of the mask at embossment points. The mask materials consist of an outer layer (polypropylene spunbond, white), filter layer (polypropylene melt-blown, white) and inner layer web (polypropylene thermal-bonded, white (22 GSM Thermal Bond White Material)). Each mask has two ear loops ultrasonically welded onto the sides to secure the users' nose and mouth. The construction also includes a polyethylene wire nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.

The provided document is a 510(k) summary for the Banyan USA Surgical Mask Level 3. It details non-clinical laboratory testing performed to demonstrate substantial equivalence to a predicate device, rather than a study with human subjects (clinical study) for an AI/CADe device. Therefore, many of the requested criteria regarding AI device studies are not applicable.

Here's the information that can be extracted and a clear indication of which points are not applicable:

1. A table of acceptance criteria and the reported device performance

Ask a specific question about this device