Search Results

HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is 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 of the wearer to blood and body fluids. The HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is a single use, disposable device, provided non-sterile.

The subject device is an ASTM F2100 Level 1 (green in color) Surgical Mask. The ASTM F2100 Level 1 Surgical Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties and a malleable nosepiece. The HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is provided with fog-free foam. These masks are single use, disposable devices, provided non-sterile.

This information describes the performance testing for a medical device (a surgical mask), not an AI/ML device. Therefore, many of the requested criteria regarding AI/ML studies are not applicable.

Here's the breakdown of the provided information:

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

Ask a specific question about this device