Search Results

Disposable Surgical Face Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, blood and body fluids, and particulates material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The face mask is single use, disposable devices provide non-sterile.

The subject device is a three-layer and flat-pleated mask. The mask materials consist of non-woven/ outer layer (polypropylene spunbond), melt blown/ filter layer (polypropylene melt-blown) and non-woven/ inner layer (polypropylene spunbond). Each mask contains the ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece to provide a firm fit over the nose.

The subject device is a single-use, disposable device, provided non-sterile.

This document is a 510(k) summary for a Disposable Surgical Face Mask. The information provided is primarily focused on the non-clinical performance and biocompatibility testing of the device to demonstrate substantial equivalence to previously cleared predicate devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Ask a specific question about this device