Procure with Confidence: The FDA 510(k) AAMI Level 4 Gown
As a procurement director, your primary pain point is risk. Sourcing AAMI Level 4 gowns is a high-risk purchase; if the product is non-compliant, the hospital bears the liability. The Medtecs IL-4063WKTP is the de-risked solution. It is a fully compliant AAMI Level 4 gown that meets all US FDA 510(k) premarket notification requirements. This is not just a claim—it is a verifiable regulatory status.
By choosing this 510(k) compliant gown, you are ensuring your institution is protected from a regulatory, legal, and clinical perspective. It’s the compliant, high-quality, heavy-duty (63gsm) gown your clinicians and risk managers demand.
Why FDA 510(k) Compliance is Non-Negotiable
The regulatory landscape for PPE has changed. Understand why 510(k) is the new standard for procurement, and how this gown meets that standard.
What is 510(k) Compliance for Gowns?
The US FDA now requires that any non-sterile gown making AAMI Level 4 protection claims must have a 510(k) premarket notification. This means the manufacturer has submitted technical data, including all AAMI test results (like ASTM F1670 and F1671), to the FDA for review. A 510(k) compliant status means the FDA has reviewed the data and the product can be legally marketed as AAMI Level 4. Purchasing a gown without this is a significant compliance risk.
The IL-4063WKTP is Your Verifiable Solution
The IL-4063WKTP meets this requirement. This simplifies your vendor qualification process. You can procure this gown with the full assurance that it is compliant with all federal regulations, protecting your hospital from liability and ensuring staff safety.
Built to Exceed the Standard
This gown doesn’t just meet the minimum requirements. It is a premium product designed for clinician satisfaction.
- Regulatory: FDA 510(k) Compliant (Verifiable)
- Protection: AAMI Level 4 (Passes ASTM F1670/F1671)
- Seams: Fully Taped Seams (A requirement for L4)
- Fabric: 63gsm Heavy-Duty (Reduces tears, fewer complaints)
The Procurement Risk Matrix
| Gown Type | IL-4063WKTP (510k) | Non-510(k) Gown |
|---|---|---|
| FDA Regulatory Status | Compliant, Legally Marketed | Non-Compliant, Illegal to market as L4 |
| AAMI L4 Claim | Verified by FDA review | Unverified, high-risk claim |
| Hospital Liability | Low (Following regulations) | High (Using non-compliant device) |
| Procurement Confidence | High | Low |
