Welcome to Koos Medical Innovation

Our Mission

At Koos Medical Innovations (KMI), we are dedicated to enhancing the quality of isolation gowns—a critical component of medical PPE—that currently fall short of FDA requirements, thereby heightening the risk of healthcare-associated infections.

  • Healthcare-associated infections (HAIs) are infections that patients acquire during or shortly after receiving healthcare, leading to significant morbidity, mortality, and financial burden.

  • According to the CDC, on any given day, 1 in 31 U.S. hospital patients suffer from an HAI, resulting in direct medical costs of at least $28.4 billion annually, with an additional $12.4 billion in societal costs.

  • These infections are often spread via healthcare workers, making effective PPE critical to preventing HAIs.

  • Disposable isolation gowns often fail to meet FDA critical zone coverage requirements, increasing the risk of HAIs.

The Failures of Isolation Gowns

Through real-life examples we illustrate how isolation gowns fail to provide the required coverage of critical zone A, increasing the risk of infections spreading within hospitals.

The FDA regulates medical isolation gowns and specifications state:

By design, isolation gowns are required to provide 360° protection to the healthcare worker in a manner that, at a minimum, ensures that both arms and the front, sides, and back of the body from the knees up to but not including the neck, are fully covered during movement and use

FDA Critical Zones for Isolation Gowns

https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns

Introducing the KMI Design

  • Our patented design creates a custom fit at the neck to prevent the gown from gaping or sagging, providing continuous, effective coverage and meeting FDA requirements.

  • Like a belt that holds baggy pants up, our adjustable neck material secures our one-size-fits-all gown in place.

  • Adhesive closure at the side of the neck, rather than at the back, for ease of use and to prevent hair from getting caught. No more painful hair pulling!

  • SMS Polypropylene Material

Disposable AAMI Level 2 Isolation Gowns

Join the Movement

Ineffective isolation gowns that do not meet FDA standards continue to be sold in the US due to their “exempt” status classification by the FDA. We have launched a petition for the FDA to reclassify non-surgical gowns as "non-exempt." This crucial change would mandate a 510(k) premarket submission from all manufacturers, ensuring that their gowns meet FDA standards before reaching the hands of frontline workers.

Together, we can drive positive change and ensure a safer, healthier future for healthcare workers and patients alike.