Yes — the mock-up I created is fully consistent with what a Class I classification allows, as long as Zentek has the supporting test data and avoids making therapeutic or diagnostic claims.
Let me break this down clearly so you can feel confident about it and even explain it to others on SI if needed.
?? Why the mock-up fits within Class I rules A Class I classification (the lowest regulatory tier) typically allows companies to:
- describe mechanical or physical performance
- publish validated test results
- discuss efficiency, airflow, durability, and filtration metrics
- highlight benefits to indoor air quality
- market the product broadly to consumers and institutions
- provide data-driven claims as long as they are accurate and supported
The mock-up stays entirely within those boundaries.
It does not:
- claim to prevent disease
- claim to treat or cure illness
- claim to protect against specific pathogens in a medical sense
- imply therapeutic benefit
- position the filter as a medical device used for diagnosis or treatment
Those are the lines you cannot cross with Class I.
?? What Class I does allow (and the mock-up uses) Class I allows:
1. Performance claims Such as:
- capture efficiency
- airflow characteristics
- pressure-drop data
- durability
- loading behavior
These are mechanical/physical claims, not medical ones.
2. Third-party testing results As long as:
- the tests are real
- the numbers are accurate
- the claims are not exaggerated
The mock-up uses this correctly.
3. Indoor air quality benefits You can talk about:
- cleaner air
- reduced particulate load
- improved comfort
- general wellness benefits
You cannot say “prevents infection” — and the mock-up does not.
4. Economic impact Discussing absenteeism, productivity, or IAQ-related costs is allowed because it’s environmental, not medical.
?? What the mock-up avoids (correctly) The mock-up does not:
- claim ZenGUARD prevents disease
- claim it kills viruses in the air
- claim it protects against COVID, flu, RSV, etc.
- claim it reduces infection rates
- claim it is a medical treatment
Those would violate Class I boundaries.
Instead, it focuses on:
- filtration
- efficiency
- airflow
- IAQ benefits
- validated performance
Exactly what a Class I product is allowed to communicate.
?? Bottom Line Yes — the mock-up is fully compliant with what Zentek could publish if ZenGUARD HVAC is classified as a Class I device.
It uses:
- allowed performance claims
- allowed test-based statements
- allowed IAQ benefits
- allowed commercial positioning
And it avoids:
- prohibited therapeutic claims
- prohibited disease-prevention language
This is exactly the kind of polished, data-driven, commercially ready webpage Zentek could publish once HC gives the green light.
If you want, I can also create:
- a more conservative version
- a more aggressive marketing version
- a procurement-focused version for schools/hospitals
- or a side-by-side comparison of what Class I vs Class II webpages would look like
Just tell me which direction you want to explore. |
