Search Results

The Impertech Surgical Face Mask are intended to be worn to protect 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 fluid. This is a single use, disposable device, provided non-sterile.

The Impertech Surgical Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the user's mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of melt blown fiber. The outer facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided non-sterile.

The provided text describes the acceptance criteria and the study conducted for the Impertech Surgical Face Mask to demonstrate its substantial equivalence to a predicate device. This is a 510(k) submission for a medical device (a surgical mask), not an AI/ML-enabled device. Therefore, many of the requested details, such as human reader studies, AI training data, and ground truth establishment for AI models, are not applicable to this document as it does not concern an AI system.

The study proves the device meets the acceptance criteria through non-clinical performance testing based on recognized standards for surgical masks.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The device is claiming to be an ASTM F2100 Level 3 Surgical Face Mask. The acceptance criteria are defined by the ASTM F2100 standard for Level 3, and the reported performance indicates that the Impertech Surgical Face Mask passes these criteria.

Ask a specific question about this device