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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 ECOMA surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene melt blown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.

The provided document is a 510(k) Premarket Notification for the ECOMA Level 2 Disposable Surgical Mask with Ear Loops. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical effectiveness study of the device itself. Therefore, many of the requested categories regarding human expert studies, multi-reader multi-case studies, and human-in-the-loop performance are not applicable to this type of regulatory submission for this medical device.

Here's the information extracted from the document regarding acceptance criteria and performance, as applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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