The Compliant Solution for AAMI Level 4 Protection
As an Infection Control Professional, your primary concern is staff safety and hospital-wide compliance. Sourcing AAMI Level 4 gowns comes with a high regulatory burden. The Medtecs IL-4063WKTP is engineered to meet these exact needs, providing the highest level of certified protection while being fully compliant with all FDA requirements. This is the verifiable, high-quality solution your high-risk units (ICU, ER, Oncology) demand.
With this gown, you can be confident that you are providing your staff with a barrier that meets the most rigorous scientific and regulatory standards.
Verifiable Compliance and Uncompromising Safety
This gown is built to eliminate the guesswork in PPE procurement. It provides clear, verifiable compliance with all critical standards for high-risk protection, protecting your staff and your institution.
FDA 510(k) Compliant for AAMI Level 4
The US FDA now requires 510(k) premarket notification for any non-sterile gown claiming AAMI Level 4 protection. The IL-4063WKTP meets this critical regulatory requirement. This 510(k) compliance means our claims have been reviewed by the FDA, ensuring our gown is legally marketed and performs to the standard we claim. This is your number one assurance against non-compliant products.
Passes ASTM F1671: The Viral Barrier Test
For Infection Control, this is non-negotiable. An AAMI Level 4 gown *must* pass ASTM F1671 to prove it provides a barrier against viral penetration. Our gown is certified to pass this test, making it the appropriate choice for protecting staff from blood-borne pathogens and infectious diseases like COVID-19.
Fully Taped Seams: The Key to an Impervious Gown
A Level 4 gown cannot have stitched seams. Our IL-4063WKTP features heat-sealed taped seams, which physically seal all potential micro-perforations. This design is essential for passing the AAMI Level 4 standard and ensures that the entire gown, not just the fabric, is 100% impervious to fluids under pressure.
Heavy-Duty 63gsm Fabric: Reducing Barrier Breaches
A common point of failure is tearing. Our 63gsm heavy-duty fabric provides superior tear and puncture resistance. For Infection Control, this means a lower risk of staff exposure due to gown failure, reducing the chance of hospital-acquired infections (HAIs) and staff exposure incidents.
- Standard: AAMI Level 4
- Regulatory: FDA 510(k) Compliant
- Viral Barrier: Passes ASTM F1671
- Blood Barrier: Passes ASTM F1670
- Seams: Fully Taped Seams (Impervious)
- Fabric: 63gsm Heavy-Duty, Tear-Resistant
Compliance Check: AAMI Level 4 vs. Non-Compliant Gowns
| Feature | IL-4063WKTP (L4 Compliant) | Non-Compliant “”Level 4″” Gown |
|---|---|---|
| FDA 510(k) | Yes, Compliant | No, or false claim |
| ASTM F1671 (Viral) | Yes, Certified Pass | Not tested, or fails |
| Seams | Fully Taped Seams | Often Stitched or Ultrasonic (Non-impervious) |
| Risk | Mitigated | High risk of staff exposure & liability |
