Medical

C-POLAR and NanoFlashing™ questions, with the company’s answers and the sources they come from.

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.

Reviewed on .

All questions

Would integrating the material change the intended use of an existing medical device?

What the intended use of a device is, and whether a change alters it, is determined by the device's own sponsor under the rules that apply to that device.

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. The Terms of Use state: “A prospective partner or manufacturer must perform its own testing, validation, compatibility work, safety review, risk review, and quality controls for its proposed product and use.” The Terms also state: “Nothing on the Site authorizes anyone to manufacture, integrate, market, resell, or describe a product as C-POLAR-enabled.”

Source: C-POLAR — Terms of Use, sections 4 and 5, https://cpolar.tech/terms/; C-POLAR — NanoFlashing™ Medical, https://cpolar.tech/medical/.

Reviewed on .

All questions

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 .

All questions

Does the duration of patient contact change the required biological evaluation?

What a device sponsor must hold or submit is decided by that sponsor and by the authority it submits to, and the company gives no regulatory advice.

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 of Use state: “A prospective partner or manufacturer must perform its own testing, validation, compatibility work, safety review, risk review, and quality controls for its proposed product and use.”

What the company states about its own testing is on the Validation page. The Validation page states that NanoFlashing™ is tested under Good Laboratory Practice to US EPA Health Effects Test Guidelines, and names Product Safety Labs, Study 65321, Study 65322, Study 65323 and Study 65324. Those are studies of the material under the guidelines named, and they are not a biological evaluation of a finished device.

Source: C-POLAR — Validation, https://cpolar.tech/validation/; C-POLAR — Terms of Use, sections 4 and 5, https://cpolar.tech/terms/. A copy may be made available on our review of the request.

Reviewed on .

All questions

Can the treatment tolerate the intended sterilisation process?

The company publishes no result for that exposure.

The conditions listed on the Validation page are heavy dust loaded, fast air flow, used filter for 1 year, after 60 washes, after 2 years of storage, and after 60C for 64 days. A sterilisation process is not among them, and the company publishes no sterilisation study and no compatibility statement for one. The Terms of Use state: “A reported result describes only what the identified test found.” 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.

Source: C-POLAR — Validation, https://cpolar.tech/validation/; C-POLAR — Terms of Use, sections 3 and 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.

Reviewed on .

All questions

Does sterilisation alter the material's functional properties even if it remains physically intact?

The company publishes no result for that exposure.

The conditions listed on the Validation page are heavy dust loaded, fast air flow, used filter for 1 year, after 60 washes, after 2 years of storage, and after 60C for 64 days. A sterilisation process is not among them, and the company publishes no before-and-after measurement for one. NanoFlashing™ is a permanent positive polarity engineered into filter media itself. It is a physical property of the filter. The Terms of Use state: “A reported result describes only what the identified test found.” 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.

Source: C-POLAR — Validation, https://cpolar.tech/validation/; C-POLAR — Terms of Use, sections 3 and 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.

Reviewed on .

All questions

Can the material be supplied with documented cleanliness limits appropriate to the proposed device?

The company publishes no cleanroom classification, no shedding measurement and no packaging cleanliness class.

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. A cleanliness limit for delivered material is a term of the agreement that governs the delivery, and C-POLAR publishes none.

The Terms of Use state: “A prospective partner or manufacturer must perform its own testing, validation, compatibility work, safety review, risk review, and quality controls for its proposed product and use.”

Source: C-POLAR — Terms of Use, sections 4, 5 and 6, 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.

Reviewed on .

All questions

Would packaging aging affect sterile-barrier integrity for a device containing the material?

The company publishes no result for that exposure.

The company publishes no packaging-ageing result and no sterile-barrier result. The Terms of Use state: “A reported result describes only what the identified test found.” 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.

Source: C-POLAR — Validation, https://cpolar.tech/validation/; C-POLAR — Terms of Use, sections 3 and 4, https://cpolar.tech/terms/.

Reviewed on .

All questions

Does the material interact with drugs passing through a proposed fluid-contact device?

The company publishes no result for that exposure.

The company publishes no interaction study. The Terms of Use state: “A reported result describes only what the identified test found.” 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.

Source: C-POLAR — Validation, https://cpolar.tech/validation/; C-POLAR — Terms of Use, sections 3 and 4, https://cpolar.tech/terms/.

Reviewed on .

All questions

Could it bind a therapeutic substance that the device is meant to deliver?

The company publishes no result for that exposure.

The company publishes no binding study. What it states about the mechanism is that NanoFlashing™ attracts negatively charged particles through electrostatic attraction, and that the filter captures airborne particles mechanically and by electrostatic attraction. The Terms of Use state: “A reported result describes only what the identified test found.” 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.

Source: C-POLAR — NanoFlashing™, https://cpolar.tech/nanoflashing/; Statement of Classification for the NanoFlashing™ Air Filter, section 2.5, issued by NF Technical Products Inc.; C-POLAR — Validation, https://cpolar.tech/validation/; C-POLAR — Terms of Use, sections 3 and 4, https://cpolar.tech/terms/.

Reviewed on .

Sources

  1. C-POLAR — NanoFlashing™
  2. Statement of Classification for the NanoFlashing™ Air Filter, section 2.5, issued by NF Technical Products Inc.
  3. C-POLAR — Validation
  4. C-POLAR — Terms of Use, sections 3 and 4
All questions

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
All questions

Can the material change a device's electrical or electromagnetic safety assessment?

The Terms of Use state that a test of C-POLAR material, a component, or a prototype does not establish the performance of a finished product that incorporates it, and that construction, processing, storage, wear, cleaning, other components, and actual use may change the result.

The filter is passive. It draws no power, and it has no power supply, electrode, lamp or reservoir. The polarity is a positive electric charge at rest. A charge is a physical property. It is not a substance or a mixture of substances. This site publishes no electrical-safety or electromagnetic-compatibility test for any product.

The Terms of Use state: “A prospective partner or manufacturer must perform its own testing, validation, compatibility work, safety review, risk review, and quality controls for its proposed product and use.” Whether a device's electrical assessment changes is determined by the sponsor of that device.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 2.2, 2.4 and 3.6, issued by NF Technical Products Inc.; C-POLAR — Terms of Use, sections 3 and 5, https://cpolar.tech/terms/.

Reviewed on .

Sources

  1. Statement of Classification for the NanoFlashing™ Air Filter, sections 2.2, 2.4 and 3.6, issued by NF Technical Products Inc.
  2. C-POLAR — Terms of Use, sections 3 and 5
All questions

Would a ventilator accessory containing the material alter delivered pressure or volume?

The Terms of Use state that a test of C-POLAR material, a component, or a prototype does not establish the performance of a finished product that incorporates it, and that construction, processing, storage, wear, cleaning, other components, and actual use may change the result.

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 company publishes no result for a ventilator accessory and no pressure or volume measurement for any product.

The Terms of Use state: “A prospective partner or manufacturer must perform its own testing, validation, compatibility work, safety review, risk review, and quality controls for its proposed product and use.” They also state: “Use evidence, specifications, instructions, and warnings specific to the actual finished product and use.” NanoFlashing™ is a technology; the name, rating and sale of a product that carries it are set by that product's maker and seller.

Source: C-POLAR — Terms of Use, sections 3, 4 and 5, https://cpolar.tech/terms/; C-POLAR — NanoFlashing™ Medical, https://cpolar.tech/medical/.

Reviewed on .

All questions

Does a device sponsor need separate evidence for extractables and leachables?

What a device sponsor must hold or submit is decided by that sponsor and by the authority it submits to, and the company gives no regulatory advice.

The company publishes no extractables study and no leachables study. The company's statement that the filter emits nothing into the air passing through it is about a filter in use, and it is not an extractables or leachables result.

Source: Statement of Classification for the NanoFlashing™ Air Filter, section 2.4, issued by NF Technical Products Inc.

Reviewed on .

Sources

  1. Statement of Classification for the NanoFlashing™ Air Filter, section 2.4, issued by NF Technical Products Inc.
All questions

Can a material supplier support a regulator's confidential review without disclosing trade secrets publicly?

A review that needs more than the company's published pages is arranged in writing, and material sent through a general Site form is not treated as confidential.

The Terms of Use state: “Do not send confidential, proprietary, patient, or trade-secret information through a general Site form. C-POLAR does not accept a duty of confidentiality for material sent through a general Site form unless a Separate Agreement covering that material is already in force.” A Separate Agreement is a written agreement signed by an authorized C-POLAR officer.

Each numbered report the company cites is named with its institution and number, and with its date and standard where the report gives them.

Source: C-POLAR — Terms of Use, sections 1 and 10, https://cpolar.tech/terms/; C-POLAR — Validation, https://cpolar.tech/validation/; C-POLAR — Contact, https://cpolar.tech/contact/.

Reviewed on .

All questions

Would reprocessing a reusable medical device alter the supported treatment function?

The company publishes no result for that exposure.

The conditions listed on the Validation page are heavy dust loaded, fast air flow, used filter for 1 year, after 60 washes, after 2 years of storage, and after 60C for 64 days. A reprocessing cycle for a reusable device is not among them, and the company publishes no reprocessing study. The one article the company labels is replaced rather than reprocessed: “Do not wash, vacuum, brush, blow out or reuse this filter.” The Terms of Use state: “A reported result describes only what the identified test found.” 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.

Source: C-POLAR — Validation, https://cpolar.tech/validation/; C-POLAR — Terms of Use, sections 3 and 4, https://cpolar.tech/terms/.

Reviewed on .

Sources

  1. NanoFlashing™ Air Filter label, Directions for Use
  2. C-POLAR — Validation
  3. C-POLAR — Terms of Use, sections 3 and 4
All questions

Is the material's quality agreement compatible with the device maker's change-control obligations?

For a prospective partner, a commitment from C-POLAR is one stated in a Separate Agreement, which is a written agreement signed by an authorized C-POLAR officer.

The Terms of Use state that accessing the Site or contacting C-POLAR through the Site does not create a partnership, agency, joint venture, distribution right, supply commitment, license, exclusive right, or other business relationship, and that a prospective partner may rely only on a commitment stated in a Separate Agreement. They also state that where these Terms conflict with a Separate Agreement or an express written C-POLAR warranty, that document controls. C-POLAR publishes no quality agreement and no change-notification commitment.

Source: C-POLAR — Terms of Use, sections 1, 5 and 6, https://cpolar.tech/terms/.

Reviewed on .

All questions

Can the device manufacturer trace implanted or long-term-contact components to a specific supplied lot?

Production records and release decisions belong to the manufacturing partner that makes the product, and C-POLAR publishes none of them.

Every commercial NanoFlashing™ product is made by a manufacturing partner, in their facility, in their format, and lot identification on delivered material is a term of the agreement that governs the delivery. The Medical devices chapter describes a Research Application, and it does not describe a finished product currently available from C-POLAR for that use.

What a device manufacturer must trace, and how far back, is decided by that manufacturer under the rules that apply to it.

Source: C-POLAR — About, https://cpolar.tech/about/; C-POLAR — Terms of Use, sections 4 and 6, https://cpolar.tech/terms/.

Reviewed on .

All questions

Does the product's design history identify the risk created by adding the treated material?

The Terms of Use state that a test of C-POLAR material, a component, or a prototype does not establish the performance of a finished product that incorporates it, and that construction, processing, storage, wear, cleaning, other components, and actual use may change the result.

A design history file belongs to the manufacturer that opened it, and C-POLAR holds none. The Terms of Use state: “A prospective partner or manufacturer must perform its own testing, validation, compatibility work, safety review, risk review, and quality controls for its proposed product and use.” They also state: “Use evidence, specifications, instructions, and warnings specific to the actual finished product and use.” The Medical devices chapter describes a Research Application, and it does not describe a finished product currently available from C-POLAR for that use.

Source: C-POLAR — Terms of Use, sections 3, 4 and 5, https://cpolar.tech/terms/.

Reviewed on .

All questions

Would a clinical investigation be needed for the proposed device claim?

What a device sponsor must hold or submit is decided by that sponsor and by the authority it submits to, and the company gives no regulatory advice.

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 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 company publishes no clinical investigation and no clinical result of any kind.

Source: C-POLAR — Terms of Use, sections 3 and 4, https://cpolar.tech/terms/; C-POLAR — NanoFlashing™ Medical, https://cpolar.tech/medical/. A materials review that needs more than the company's published pages is arranged in writing, through [email protected] on the Contact page.

Reviewed on .

All questions

Can a component supplier's safety testing replace any part of the finished device's usability assessment?

The Terms of Use state that a test of C-POLAR material, a component, or a prototype does not establish the performance of a finished product that incorporates it, and that construction, processing, storage, wear, cleaning, other components, and actual use may change the result.

They also state: “Use evidence, specifications, instructions, and warnings specific to the actual finished product and use.” The Terms of Use state: “A prospective partner or manufacturer must perform its own testing, validation, compatibility work, safety review, risk review, and quality controls for its proposed product and use.” A usability assessment is made on the finished product, with its own users, and no material test replaces any part of it.

The company publishes no usability study, no comprehension test and no record of instructions tried with first-time users.

Source: C-POLAR — Terms of Use, sections 3 and 5, https://cpolar.tech/terms/.

Reviewed on .

All questions

Does the FDA's medical-device clearance pathway (510(k)) apply to the NanoFlashing™ Medical vertical?

The company publishes no FDA position, 510(k) or other, for the Medical vertical, and its Terms of Use describe that chapter as a Research Application.

The Terms of Use state: “As of the Effective Date, the Water, Textiles, Food packaging, and Medical devices chapters describe Research Applications. They do not describe finished products currently available from C-POLAR for those uses.” The Medical page states: “The NanoFlashing™ Medical Device has a permanent positive polarity, a fixed positive charge.” The company's two classification statements, under FIFRA in the United States and under Regulation (EU) No 528/2012, are written for the NanoFlashing™ Air Filter, a panel air filter for forced-air heating, ventilation and air-conditioning systems. The Terms of Use 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.”

Source: C-POLAR — Terms of Use, section 4, https://cpolar.tech/terms/; C-POLAR — NanoFlashing™ Medical, https://cpolar.tech/medical/; Statement of Classification for the NanoFlashing™ Air Filter, section 1.2, issued by NF Technical Products Inc.; Statement of Regulatory Status for the NanoFlashing™ Air Filter, section 1.2, C-POLAR Technologies, Inc., 11 September 2026.

Reviewed on .

Sources

  1. C-POLAR — Terms of Use, section 4
  2. C-POLAR — NanoFlashing™ Medical
  3. Statement of Classification for the NanoFlashing™ Air Filter, section 1.2, issued by NF Technical Products Inc.
  4. Statement of Regulatory Status for the NanoFlashing™ Air Filter, section 1.2, C-POLAR Technologies, Inc., 11 September 2026
All questions

Would a room filter provide a different function from local extraction at a dental chair?

A filter acts only on the air that passes through it, and it does not capture at the source.

The filter captures airborne particles mechanically and by electrostatic attraction. The filter is passive. It draws no power, and it has no power supply, electrode, lamp or reservoir. Local extraction at a chair is a different function, and C-POLAR does not supply it. General enquiries go to [email protected].

Source: C-POLAR — NanoFlashing™, https://cpolar.tech/nanoflashing/; C-POLAR — NanoFlashing™ Air, https://cpolar.tech/air/; C-POLAR — Terms of Use, https://cpolar.tech/terms/.

Reviewed on .

All questions

Can a proposed unit operate beside equipment that produces water mist?

The NanoFlashing™ Air Filter is for use in dry air.

The label states that it is for use in dry air only, that it must not be used in ducts carrying liquid water, steam or oil mist, or anywhere the media may become wet, and that a filter whose media is torn, crushed, wet or visibly damaged must not be installed. Where a powered unit stands in a room is set by the maker of that unit. General enquiries go to [email protected].

Source: NanoFlashing™ Air Filter label; C-POLAR — Terms of Use, https://cpolar.tech/terms/.

Reviewed on .

Sources

  1. NanoFlashing™ Air Filter label
  2. C-POLAR — Terms of Use
All questions

Does a treatment room need assessment with the door opening between appointments?

C-POLAR publishes no assessment of a particular room.

The NanoFlashing™ filter has no fan and no moving part; its resistance adds to the pressure the fan works against, and the label directs that it not be used where it would restrict airflow beyond the system's specification. The filter is passive. It draws no power, and it has no power supply, electrode, lamp or reservoir. The airflow in a room is set by the ventilation system and by the equipment installed in it. The label states that results in a building depend on the system, the airflow, and how well the filter fits its track. General enquiries go to [email protected]. The field observations on the Validation page are site measurements, reported separately from laboratory testing, and they were measured with MicronView's 405 nm Bio-fluorescent Air Monitoring System, which distinguishes biological particles from inert dust in real time.

Source: NanoFlashing™ Air Filter label; C-POLAR — NanoFlashing™, https://cpolar.tech/nanoflashing/; C-POLAR — Terms of Use, https://cpolar.tech/terms/; C-POLAR — Validation, https://cpolar.tech/validation/.

Reviewed on .

All questions

Can local extraction and room filtration operate together without defeating the intended source-capture airflow?

Local extraction and room filtration are different functions; the NanoFlashing™ filter has no fan and no moving part, and its resistance adds to the pressure its system's fan works against.

The filter is passive. It draws no power, and it has no power supply, electrode, lamp or reservoir. The airflow in a room is set by the ventilation system and by the equipment installed in it. C-POLAR publishes no airflow design and no room assessment. General enquiries go to [email protected].

Source: C-POLAR — NanoFlashing™, https://cpolar.tech/nanoflashing/; C-POLAR — Terms of Use, https://cpolar.tech/terms/.

Reviewed on .

All questions

Would positioning a purifier behind a clinician pull air across the patient?

The way a powered unit moves air, including where it draws from and whether it creates a draught, is a property of that unit and is set by the manufacturer that makes it.

The filter is passive. It draws no power, and it has no power supply, electrode, lamp or reservoir. The published position is that every commercial NanoFlashing™ product is made by a manufacturing partner, in their facility, in their format. General enquiries go to [email protected]. NanoFlashing™ is a technology; the name, rating and sale of a product that carries it are set by that product's maker and seller.

Source: C-POLAR — NanoFlashing™, https://cpolar.tech/nanoflashing/; C-POLAR — About, https://cpolar.tech/about/; C-POLAR — Terms of Use, https://cpolar.tech/terms/.

Reviewed on .

All questions

Can the unit withstand frequent repositioning between treatment rooms?

The label states that the filter and its frame must not be cut, folded, trimmed, bent, punctured or altered, and that a filter whose media is torn, crushed, wet or visibly damaged must not be installed.

C-POLAR publishes no durability rating for repeated handling, and a movable unit is a finished product of its maker. General enquiries go to [email protected].

Source: NanoFlashing™ Air Filter label; C-POLAR — Terms of Use, https://cpolar.tech/terms/.

Reviewed on .

Sources

  1. NanoFlashing™ Air Filter label
  2. C-POLAR — Terms of Use
All questions

Does the product address aerosol exposure generated at a nail-care workstation?

C-POLAR publishes no evidence for a nail-care workstation, and it makes no claim about the aerosol generated at one.

NanoFlashing™ attracts negatively charged particles through electrostatic attraction. C-POLAR publishes no evidence for a gas, a vapour or an odour, and it makes no claim about one. The filter captures airborne particles mechanically and by electrostatic attraction. General enquiries go to [email protected].

Source: C-POLAR — NanoFlashing™, https://cpolar.tech/nanoflashing/.

Reviewed on .

All questions

Would a salon need separate controls for solvent vapours despite installing the filter?

The company makes no claim that the filter controls solvent vapours.

C-POLAR publishes no evidence for a gas, a vapour or an odour, and it makes no claim about one.

NanoFlashing™ attracts negatively charged particles through electrostatic attraction. The filter captures airborne particles mechanically and by electrostatic attraction. General enquiries go to [email protected].

Source: C-POLAR — NanoFlashing™, https://cpolar.tech/nanoflashing/; C-POLAR — Validation, https://cpolar.tech/validation/.

Reviewed on .

All questions

Can the filter be used in a veterinary examination room with frequent animal shedding?

C-POLAR publishes no evidence for a veterinary examination room, and heavier loading brings the replacement point forward.

The filter captures airborne particles mechanically and by electrostatic attraction. The replacement point is the pressure drop and the interval stated on the product's own label. General enquiries go to [email protected].

Source: C-POLAR — NanoFlashing™, https://cpolar.tech/nanoflashing/; NanoFlashing™ Air Filter label; C-POLAR — Terms of Use, https://cpolar.tech/terms/.

Reviewed on .

Sources

  1. C-POLAR — NanoFlashing™
  2. NanoFlashing™ Air Filter label
  3. C-POLAR — Terms of Use
All questions

Does a mobile clinic have enough electrical and service capacity for the complete unit?

The NanoFlashing™ Air Filter draws no power.

The filter is passive. It draws no power, and it has no power supply, electrode, lamp or reservoir. A complete unit is a finished product of its maker, and its power and service requirements come from that maker. The published position is that every commercial NanoFlashing™ product is made by a manufacturing partner, in their facility, in their format. General enquiries go to [email protected].

Source: C-POLAR — NanoFlashing™, https://cpolar.tech/nanoflashing/; C-POLAR — About, https://cpolar.tech/about/; C-POLAR — Terms of Use, https://cpolar.tech/terms/.

Reviewed on .

All questions

Can maintenance be scheduled between appointments without contaminating clean supplies?

The label sets how a used filter is handled, and the clinic sets when maintenance is done.

The label states: “A used filter holds the dust and microorganisms it has taken out of the air.” It directs that a used filter is put straight into a bag or waste container, that it is not shaken out or blown clean, that gloves are worn, with eye protection and a dust mask where dust is heavy, and that hands are washed after handling. General enquiries go to [email protected].

Source: NanoFlashing™ Air Filter label.

Reviewed on .

Sources

  1. NanoFlashing™ Air Filter label
All questions

Would use in a dialysis waiting area require review distinct from use in the treatment equipment?

The NanoFlashing™ Air Filter is a panel air filter for a forced-air heating, ventilation and air-conditioning system, and it is not part of treatment equipment.

The published Terms of Use state: “As of the Effective Date, the Water, Textiles, Food packaging, and Medical devices chapters describe Research Applications. They do not describe finished products currently available from C-POLAR for those uses.” General enquiries go to [email protected].

Source: C-POLAR — Terms of Use, https://cpolar.tech/terms/; C-POLAR — NanoFlashing™ Air, https://cpolar.tech/air/; C-POLAR — NanoFlashing™ Medical, https://cpolar.tech/medical/; NanoFlashing™ Air Filter label.

Reviewed on .

All questions

Can a physiotherapy clinic maintain its intended airflow during vigorous group sessions?

C-POLAR publishes no assessment of a particular room.

The NanoFlashing™ filter has no fan and no moving part; its resistance adds to the pressure the fan works against, and the label directs that it not be used where it would restrict airflow beyond the system's specification. The filter is passive. It draws no power, and it has no power supply, electrode, lamp or reservoir. The airflow in a room is set by the ventilation system and by the equipment installed in it. The label states that results in a building depend on the system, the airflow, and how well the filter fits its track. General enquiries go to [email protected]. The field observations on the Validation page are site measurements, reported separately from laboratory testing, and they were measured with MicronView's 405 nm Bio-fluorescent Air Monitoring System, which distinguishes biological particles from inert dust in real time.

Source: NanoFlashing™ Air Filter label; C-POLAR — NanoFlashing™, https://cpolar.tech/nanoflashing/; C-POLAR — Terms of Use, https://cpolar.tech/terms/; C-POLAR — Validation, https://cpolar.tech/validation/.

Reviewed on .

All questions

Does a proposed unit create draughts that disrupt precise clinical or cosmetic work?

The way a powered unit moves air, including where it draws from and whether it creates a draught, is a property of that unit and is set by the manufacturer that makes it.

The filter is passive. It draws no power, and it has no power supply, electrode, lamp or reservoir. The published position is that every commercial NanoFlashing™ product is made by a manufacturing partner, in their facility, in their format. General enquiries go to [email protected].

Source: C-POLAR — NanoFlashing™, https://cpolar.tech/nanoflashing/; C-POLAR — About, https://cpolar.tech/about/; C-POLAR — Terms of Use, https://cpolar.tech/terms/.

Reviewed on .

All questions

Can a clinic assess the product without collecting identifiable patient health data?

C-POLAR does not ask for patient data and does not accept it through this website.

The published Terms of Use state that confidential, proprietary, patient or trade-secret information must not be sent through a general Site form, and that C-POLAR does not accept a duty of confidentiality for material sent through a general Site form unless a Separate Agreement covering that material is already in force. The published contact form asks for a first name, a last name, a work email address, a company and a message, and the message field is limited to 255 characters. The Privacy Policy states that a submission is received through Mailchimp, an Intuit service, and that every successful submission adds the work email address to a C-POLAR mailing list. An assessment made by a clinic is the clinic's own.

Source: C-POLAR — Terms of Use, https://cpolar.tech/terms/; C-POLAR — Privacy Policy, https://cpolar.tech/privacy/; C-POLAR — Contact, https://cpolar.tech/contact/.

Reviewed on .

All questions

Who should review promotional claims displayed at the reception desk of a clinic using the product?

Written permission from C-POLAR is required before anyone describes a product as C-POLAR-enabled.

The published Terms of Use state: “Nothing on the Site authorizes anyone to manufacture, integrate, market, resell, or describe a product as C-POLAR-enabled. Nothing authorizes anyone to describe itself as a C-POLAR partner. Written permission is required.” They add: “Site Content is not a product specification, design file, manufacturing instruction, validation report, certificate, patent license, technology license, or permission to make a product claim.” Permission requests go to [email protected].

Source: C-POLAR — Terms of Use, https://cpolar.tech/terms/.

Reviewed on .

All questions

More questions on this subject

Clinical outcomes, ethics and inference

Hospital and care-facility deployment

Other US agencies and product categories

Research readiness and development decisions

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.