Search Results

The Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield 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 masks are single use, disposable device, provided non-sterile.

The Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are composed of four layers and are flat-pleated and offers both ear loops and tie strings types. The mask materials consist of outer layer (Polypropylene Spunbond), insertion layer (Polypropylene Spunbond) and inner layer (Polypropylene Spunbond), and middle layer filter (polypropylene melt-blown). Each mask contains ear loops or tie strings to secure the mask over the user's mouth and face with nose piece to firmly fit over the nose. The mask may also contain a face shield made from a polyethylene terephthalate film, with an anti-glare strip. The face shield is adhered to the top edge of the mask to cover the upper part of the face to prevent potential exposure to blood and body fluids. The mask(s) are single use, disposable device(s), provided non-sterile.

The provided text describes a 510(k) premarket notification for a surgical mask, not an AI/ML medical device. Therefore, most of the requested information regarding AI/ML device performance, such as sample sizes for test and training sets, data provenance, expert adjudication, MRMC studies, and standalone performance, is not applicable.

However, I can extract the acceptance criteria and reported performance for the surgical mask based on the provided tables and text.

Acceptance Criteria and Device Performance for Unico High Performance Surgical Mask

Ask a specific question about this device