EUA approved medical gowns
Our reusable isolation gowns are made with a technologically advanced fabric manufactured in the United States which is engineered to meet and exceed AAMI Level 2 and 3 standards. The fabric was specifically selected for its ability to fulfill AAMI standards while withstanding the rigors of commercial laundry.
Our reusable medical gowns are approved for use under the FDA EUA (Emergency Use Authorization)*.
All our gown fabric is 99% polyester/1% carbon. For gowns with the cuff option, the cuff material is 95% cotton/5% spandex with TPU (thermoplastic polyurethane, a durable, flexible, waterproof membrane bonded to our the spandex).
AAMI Level 2 and 3 specifications
| AAMI Level 2 | AAMI Level 3 | |
|---|---|---|
| Use | SP* N CP | SP* N CP E ICU |
| Anticipated Fluid Level Exposure | Low | Moderate |
| Testing | AATCC 42 AATCC 127 | AATCC 42 AATCC 127 |
| Spray Impact Requirement | ≤ 1.0g | ≤ 1.0g |
| Hydrostatic Pressure Requirement | ≥ 20cm | ≥ 50cm |
| Lifespan (Approximate) | 100 washes | 100 washes |
LEGEND
SP • Standard Precautions** N • Nursing CP • Contract Precautions E • Emergency ICU • Intensive Care Unit
* Reusa gowns marketed under FDA FEI 3016690615, device numbers on file.
** Per CDC Guidelines on Standard Precautions, the use of isolation gowns is indicated for some interactions between healthcare workers and patients. Transmission-Based Precautions (Contact, Droplet, and Airborne Precautions) are always used in addition to Standard Precautions. Isolation gowns are indicated for use whenever Contact Precautions are in effect, and maybe appropriate when Droplet and/or Airborne Precautions are in effect, depending on the nature of the interaction between the healthcare worker and patient as well as the extent anticipated blood, body fluid, or pathogen exposure. For more information visit the CDC website at cdc.gov.
Source: Siegel JS, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory Committee, Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007).