Is the proposed component intended to contact intact skin, compromised skin or an internal fluid path?

Is the proposed component intended to contact intact skin, compromised skin or an internal fluid path?

The company publishes no contact category for a component, because it offers no medical component.

The Medical devices chapter states that the NanoFlashing™ Medical Device has a permanent positive polarity, a fixed positive charge. 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. What the company states about skin contact is a certification and a laboratory study of the material: NanoFlashing™ is certified to OEKO-TEX® Standard 100, Product Class II, the class for products in direct contact with skin, under OEKO-TEX Service GmbH, Certificate 17.0.25812, and Product Safety Labs, Study 65324, completed 31 January 2024, reported that the material it tested “is not considered to be a contact sensitizer”. A copy may be made available on our review of the request.

Those records cover what they cover, and neither is a clearance for a device, for compromised skin or for an internal fluid path. Certificate 17.0.25812 can be checked at source in OEKO-TEX’s public label check.

Source: C-POLAR — NanoFlashing™ Medical, https://cpolar.tech/medical/; C-POLAR — Validation, https://cpolar.tech/validation/; Product Safety Labs, Study 65324, completed 31 January 2024; C-POLAR — Terms of Use, section 4, https://cpolar.tech/terms/. A materials review that needs more than the company's published pages is arranged in writing, through [email protected] on the Contact page; OEKO-TEX Label Check, read 19 September 2026, https://www.oeko-tex.com/en/label-check.

Reviewed on 21 September 2026.