Which finished-product evidence supports a medical-use, implant, sterility or patient-contact representation, if any is made?
Last reviewed: .
Which finished-product evidence supports a medical-use, implant, sterility or patient-contact representation, if any is made?
The company publishes no finished-product evidence for a medical use, an implant, a sterility claim or patient contact, and its Medical page describes a Research Application, not a finished product.
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. They also state: “A test of a material, component, sample, or prototype does not establish the safety, efficacy, suitability, durability, compatibility, manufacturability, scalability, or performance of a finished product.” and that images and descriptions may show concepts or prototypes, which are not specifications, instructions, validation reports, recommendations, warranties, offers, promises, or commitments.
What the company does publish is named on the Validation page: the pathogens tested, the conditions tested, the institutes that tested them, the peer-reviewed paper by Gong, Or, Sze et al., Microbiology Spectrum 12(9), e0409723, American Society for Microbiology, doi:10.1128/spectrum.04097-23, and, for the air-filtration, certification and safety records, the issuing body and the number for each. The paper reports laboratory results on SARS-CoV-2 in contact with treated textile, on aerosolised bovine coronavirus passed through a test filter in a wind tunnel, and on bacterial viability on treated textiles; each result belongs to the article that was tested.
Source: C-POLAR — Terms of Use, sections 3 and 4, https://cpolar.tech/terms/; C-POLAR — NanoFlashing™ Medical, https://cpolar.tech/medical/; C-POLAR — Validation, https://cpolar.tech/validation/; NanoFlashing™ Air Filter label, About this product. A materials review that needs more than the company's published pages is arranged in writing, through [email protected] on the Contact page.
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