ProGear + Oxafence Masks Receive FDA Clearance and Launch in U.S. Healthcare
Prestige Ameritech, the United States’ largest wholly domestic surgical mask manufacturer, and Singletto, developer of Oxafence Active Protection technology, announce receipt of FDA clearance for the ProGear ASTM L3 Surgical Masks with Oxafence, which are now available at ProGearHealth.com.
The ProGear+Oxafence Surgical Masks provide the highest level of ASTM performance plus Oxafence Active Protection technology, which inactivates 99.9% of tested viruses* after just five minutes. Specific viruses and conditions tested are detailed herein (see Indications for Use) and include H1N1 Influenza and OC43 Coronavirus isolates*.
Singletto and Prestige Ameritech believe Oxafence is the additional layer of protection on masks that healthcare, dental, and medical workers deserve.
“Oxafence enables all new product categories,” according to Singletto CEO John Bjornson, “We call it Active Protection. Healthcare workers need the best possible protection and that means masks that are actively killing viruses while being worn.”
The ProGear+Oxafence Surgical Masks’ four-layer design provides Bacterial and Particulate Filtration Efficiency (BFE & PFE) and Fluid Barrier Protection that meet the latest ASTM Level 3 standards (F2100-23). The patented Wave-Fit pre-bent nosepiece allows for easier donning, per Prestige Ameritech.
A 50-year veteran of the mask industry, Prestige Ameritech CEO Dan Reese, says, “We have long searched for a technology like Oxafence. We already provide high-quality products, made right here in the USA. And now, we can offer additional protection for healthcare workers – this product is like nothing else in the healthcare market today.”
Singletto Co-Founder and Chief Scientific Officer Dr. James (Jim) Chen adds, “After spending decades as a neurosurgeon and oncology researcher studying the pathogen-destroying benefits of antimicrobial photodynamic inactivation (aPDI), the core technology behind Oxafence, I am so proud to now have it in the hands of those who need it most.”
Though masks are the first Oxafence-powered product, Singletto Co-Founder and Chief Medical Officer Dr. Tom Lendvay, a pediatric surgeon, says, “We envision the day when all soft surfaces in the healthcare environment … from scrubs and PPE, to bedding, to surgical drapes, and more… are treated with Oxafence for ongoing pathogen inactivation. But we had to start somewhere – and that’s with these USA-made, high quality, Active Protection masks!”
The ProGear Surgical Masks with Oxafence are available for healthcare workers directly through Prestige Ameritech and will be available through relevant GPOs and distributors in the coming months.
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Indications for Use: The ProGear Surgical Mask with Oxafence is a single-use, disposable device used to cover the nose and mouth of the wearer to protect from transfer of microorganisms, body fluids and particulates. The outer layer of the face mask is coated with methylene blue (0.47 micrograms per square cm area).
*The ProGear Surgical Mask with Oxafence inactivates single isolates of the following test viruses after five minutes of contact with the treated surface of the face mask in laboratory (in vitro) tests under a lighting intensity of 500 ± 25 lux: Influenza A/PR/8/34/H1N1 (TC adapted, ATCC VR-1469), 3 log or 99.9% inactivation; Betacoronavirus 1 OC43 (ATCC VR-1558), 4 log or 99.99% inactivation; Feline Calicivirus F-9 (ATCC VR- 782), 4 log or 99.99% inactivation. Antiviral efficacy on other viruses has not been evaluated. Correlations between in vitro testing results and any clinical event have not been evaluated.
For more information, contact: Info@Singletto.com
About Singletto
Singletto, Inc. licenses its proprietary Oxafence® Active Protection technology to healthcare, military, and consumer brands and manufacturers to provide solutions for existing and future products, technology, and systems.
About Prestige Ameritech
Prestige Ameritech is the United States’ largest wholly domestic surgical mask manufacturer and a TERO Certified Native American-Owned Business. The company designs and manufactures premium disposable medical devices, including ProGear surgical masks, and the automated machinery that produces them.