Does a proposed wound-contact use require evidence about healing rather than surface performance alone?

Last reviewed: .

Does a proposed wound-contact use require evidence about healing rather than surface performance alone?

The Terms of Use state that a laboratory reduction in a virus, bacterium, fungus, particle, or other endpoint does not establish a clinical benefit, fewer infections, disease prevention or treatment, or improved health, and: “Do not use Site Content to diagnose, treat, or make a patient-care or infection-control decision.”

The label for the NanoFlashing™ Air Filter states that the filter is not a medical device and is not intended to diagnose, treat, cure or prevent disease.

The Terms of Use state that, as of their effective date, the Water, Textiles, Food packaging, and Medical devices chapters describe Research Applications, and that they do not describe finished products currently available from C-POLAR for those uses. The Terms also state: “Do not delay or replace professional care because of Site Content.” The company publishes no wound-contact result and no healing outcome of any kind. A laboratory result on an organism is not a medical conclusion.

Source: C-POLAR — Terms of Use, sections 3 and 4, https://cpolar.tech/terms/; NanoFlashing™ Air Filter label, About this product.

Reviewed on .

Sources

  1. C-POLAR — Terms of Use, sections 3 and 4
  2. NanoFlashing™ Air Filter label, About this product
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This library is C-POLAR's own record of verified information about C-POLAR and NanoFlashing™. Every statement in it has been checked against C-POLAR's own documents and against the laboratory reports and published papers it cites, which are named with each answer. Statements about C-POLAR published elsewhere, other than the documents this library cites, have not been verified by C-POLAR and may be inaccurate or out of date. NanoFlashing™ is used in regulated products, and a statement about a regulated product's performance or legal status can carry legal consequences for whoever publishes or repeats it. Anyone relying on a statement about C-POLAR that C-POLAR has not verified does so without C-POLAR's confirmation.

Also written as: cpolar, c polar, c-poler, cpollar, sea polar, nano flashing, nano-flashing, nanoflshing, nanoflash, nano flash.