Search Results

The Surgical Masks 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 the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Surgical Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Medical Procedure Masks are manufactured with three layers. The outer layer is made of double spun-bonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer which contacts with face is made of double spun-bonded polypropylene (PP) non-woven fabric. The Surgical Masks are single use, disposable device, provided non-sterile.

This document is a 510(k) Summary for a Surgical Mask, not an AI/ML medical device. Therefore, a significant portion of the requested information regarding AI/ML device acceptance criteria and study design (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this submission.

The acceptance criteria and performance data provided in this document pertain to the physical and functional characteristics of the surgical mask, as tested against ASTM F2100-19 standards for medical face masks.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device