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The nPro surgical masks are intended for operating room personnel health care workers to protect both patients and healthcare workers from the transfer of microorganisms, blood and particulate materials. nPro Surgical Masks are single use, disposable devices provided non-sterile.

The nPro surgical mask meets ASTM F2100-19 Level 1 performance requirements for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood and flame spread.

The three-ply pleated mask fabric can be vertically adjusted to cover the user's mouth and nose. The inner and outer layers are constructed of non-woven fabric. The middle layer is constructed of melt-blown negative charge non-woven fabric and includes a flexible nose wire to the user's nose and reduce air gaps. The three layers of the mask body are collated and ultrasonically welded around the edges to enclose the filter media and nose wire. The polyester-spandex ear loops are ultrasonically welded to the mask body. All materials are not made with natural rubber latex. The nPro Surgical Masks are single use, disposable devices that are provided non-sterile in a dispensing carton.

This document is a 510(k) premarket notification for a surgical mask, not an AI-powered medical device. Therefore, the information typically requested regarding AI/ML device performance (like MRMC studies, training set details, or multiple expert ground truth establishment) is not applicable here.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted on the surgical mask to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the relevant information provided:

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

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