Would a co-packaged chemical treatment change the analysis of an otherwise physical device?

Would a co-packaged chemical treatment change the analysis of an otherwise physical device?

It would change what is being sold, and the definition says so on its face.

40 C.F.R. § 152.500(a) defines a device so as to exclude “equipment used for the application of pesticides (such as tamper-resistant bait boxes for rodenticides) when sold separately therefrom”. An article packaged together with a pesticide is not sold separately from it, and what is offered is then a package containing a pesticide, whatever the physical part of it does. The company's position on its own article is stated in its Statement of Classification: the filter is not equipment for applying a separately supplied pesticide, and it is not sold or packaged with any pesticide. NanoFlashing™ is a permanent positive polarity engineered into filter media itself. It is a physical property of the filter.

Source: 40 C.F.R. § 152.500(a), as published on eCFR; Statement of Classification for the NanoFlashing™ Air Filter, section 3.4.

Reviewed on 21 September 2026.