Vestagen Protective Technologies, a developer of healthcare worker uniforms and scrubs, received FDA clearance as a Class II medical device for its Vestex apparel — the first daily-wear scrubs to receive this designation.
"This groundbreaking FDA medical device designation sets a new standard in the healthcare apparel market and addresses a major unmet need for healthcare worker safety," said Bill Bold, CEO of Vestagen.
Vestex apparel is designed to protect healthcare workers from exposure to microorganisms from blood, body fluids and other potentially infectious material.
The FDA cleared Vestex scrub tops, pants, skirts and lab coats to reduce the retention of Methicillin-resistant Staphylococcus aureus on the outer layer of the apparel.
The fluid-repellent fabric surface serves to resist bacteria by repelling fluids and reducing microorganisms remaining on the fabric. The antimicrobial agent then further reduces the MRSA that remains on the surface (outer layer) of the apparel.
The apparel's ability to reduce the retention of MRSA on the fabric surface has not been shown to correlate with the reduction of infections.