Enviropouch® isn’t just a great idea—it’s a medically validated, regulation-compliant solution.
- FDA 510(k) Premarket Clearance – #K924118
- Annual FDA Medical Device Establishment Registration since 1993 – Facility #1056276
- Class II Medical Device Manufacturer Status – Constructed and US FDA compliant to meet or exceed CDC guidelines
- ISO 13485 Compliant
- Health Canada Compliant
- TGA Australia Compliant
- California Proposition 65 Toxic-Free Material Compliance
Our products are evaluated not just by regulators, but by real clinicians in field and academic settings who use Enviropouch® to meet and exceed steam infection control and accreditation standards.