What Does “FDA Registered” & 510(k) Clearance Mean?
As a Class II medical device, EnviroPouch® is held to the highest steam sterilization safety and quality standards.
FDA Establishment Registration
- Registration #: 1056276
- Medical Device Class II
- Manufacturer: EnviroPak® LLC
FDA 510(k) Premarket Clearance
- Clearance #: K924118
- Originally Issued Under EnviroPak® LLC
- Validates Clinical Safety & Efficacy
Why This Matters:
- Our product isn’t just claimed safe—it’s officially cleared and reviewed.
- We undergo regular, successful audits.
- Accredited clinics and schools use our Enviropouch® to pass steam infection control audits.
Beware of Misleading Competitor Claims
Some products claim “FDA Approved”—which is inaccurate use for medical devices.
Learn more on the FDA Consumer Education Page.