Are Your Medical Devices Antimicrobial?

Introducing VACT – patented antimicrobial technology designed for medical devices

FDA Device Master File

ViaClean received their Device Master File (DMF) Number, also known as Master Allowance File (MAF) from the FDA Center for Devices and Radiological Health, on March 28, 2018.  This file is on record for medical device manufacturers to utilize in their development and registration of the application of ViaClean’s technologies on their devices.  This Master File helps simplify and expedite our partners’ filings, if needed, for use of ViaClean’s antimicrobial surface coatings under the 510(k) or de novo provisions of the Medical Devices Act.

Textiles

Under ViaClean’s FDA Master Allowance File (MAF), medical device manufacturers can incorporate the VACT technology into the textile manufacturing process of materials that used in the healthcare industry, such as surgical gowns, surgical masks, gloves etc.  This treatment creates an antimicrobial coating on the textile. 

Plastics

Under ViaClean’s FDA Master Allowance File (MAF), the VACT antimicrobial technology can be incorporated into the medical device manufacturing process (activated with UV cure for attachment and anchoring to the device plastic surface).  Some of the plastics for the VACT coating include: PET, HDPE, PVC, LDPE, polypropylene, polycarbonate, polylactide, acrylic, acrylonitrile butadiene, styrene, fiberglass, nylon.

Metals

Under ViaClean’s FDA Master Allowance File (MAF), the VACT antimicrobial technology can be incorporated into the medical device manufacturing process by spray coating, dip coating or spin coating (activated with heat cure for attachment and anchoring to the device metal surface). Some of the metals that can VACT treated include stainless steel, aluminum and titanium.

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