Does the intended target claim distinguish a public-health use from another use category?

Does the intended target claim distinguish a public-health use from another use category?

The target named in a claim is what defines the intended purpose, and the company's named targets are the airborne viruses, bacteria and fungal spores the filter captures.

40 C.F.R. § 152.5 treats fungi, bacteria and viruses as pests. The company's Statement of Classification states the intended purpose in one sentence: the filter is intended to destroy the viruses, bacteria and fungal spores it captures, on direct contact with the positive electric charge, by physical means, and only while the organism is captured by the positive electric charge. NanoFlashing™ is a permanent positive polarity engineered into filter media itself. It is a physical property of the filter. The label sets the boundary of that purpose in the company's own words: the filter treats the air that passes through it, it is not a medical device and is not intended to diagnose, treat, cure or prevent disease, and it works alongside ventilation and cleaning, not in place of them. A device is not registered under FIFRA section 3, so no agency assigns it a use category. No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 2.6 and 3.2; NanoFlashing™ Air Filter label, About This Product; 40 C.F.R. §§ 152.5 and 152.500, as published on eCFR.

Reviewed on 21 September 2026.