The reusable Personal Protective Equipment masks are now in production in Marena’s FDA approved, Georgia facility that has made post-surgical medical device gear for over twenty-five years
The reusable Personal Protective Equipment masks are now in production in Marena’s FDA approved, Georgia facility that has made post-surgical medical device gear for over twenty-five years
LAWRENCEVILLE, Ga., April 28, 2020 /PRNewswire/ -- Today, The Marena Group LLC, a U.S. healthcare company, announced that, based on an FDA Emergency Use Authorization, it has immediately begun producing a new non-surgical mask in response to the COVID-19 epidemic. Due to the national shortage and ever-growing demand for face masks, Marena will produce millions of masks for healthcare professionals, essential and active workers, and all individuals in need of comfortable and reusable antibacterial face masks.
“Being an FDA approved medical device manufacturer, our company, production lines and employees are uniquely qualified to respond to the current epidemic and shortage of face masks. We felt the obligation to answer the call to produce these new Reusable Antibacterial non-surgical PPE masks. They meet the criteria of the FDA guidance as a Class I medical device to be used by the general public and by health care professionals in a healthcare setting,” said Dale Clendon, president and chief executive officer of The Marena Group. “The Marena masks are reusable, durable and machine-washable up to 50 times without losing effectiveness; they can also be steam cleaned and ironed at high temperatures to help eliminate germ particles. They are thoughtfully designed for comfort and active, long-term use.”
Marena’s core post-surgical healthcare garments, which are all manufactured and produced in Lawrenceville, Georgia, are currently used in hundreds of hospitals and medical centers throughout the country. Their masks are expertly manufactured with no seams in critical areas. They avoid imprints on the face and allow them to be more comfortable and easier to wear for extended periods and even over N95 respirators.
Quick Facts on Marena Reusable Antibacterial Face Masks:
- The washable, reusable fabric face mask contains Silvadur™ antibacterial protection to guard the face, nose and mouth of the user and their environment.
- Provides a physical barrier to help protect against larger respiratory droplets, germ particles, and splashes. While this mask will provide some protection against, it will not act as a barrier against smaller respiratory droplets or germ particles.
- Washable up to 50 times without losing effectiveness, even at high temperatures – ≥160°F (≥71°C). May be steam cleaned between 212°F (100°C) and 270°F (132°C) or ironed up to 365°F (185°C).
- Soft, skin-friendly TriFlex™ fabric with 3D Stretch for optimal comfort.
- Lightweight, one-piece design covers the nose and mouth, with comfortable ear straps to ensure the mask stays in place.
About Marena:
The Marena Group LLC is a U.S. Class I medical device manufacturer with over 25 years of experience in the healthcare sector. Our products are sold in 60 countries globally. Marena’s mission is to help patients around the world recover comfortably and with confidence. Since 1994, Marena has been dedicated to advancing the effective use of medical-grade compression through research, innovation, design and manufacturing of garments for post-surgical recovery and long-term wellness benefits.
Our patented TriFlex™ fabric is engineered for invasive, minimal and non-invasive procedures. We are ISO: 9001, ISO 13485:2016 and GMP certified. The Marena Face Mask is authorized for sale under an FDA Emergency Use Authorization as a Non-Surgical Face Mask (Class I medical device) for the general public and/or by Health Care Professionals in a healthcare setting, as Personal Protective Equipment (PPE). This product is non-sterile and has not been tested to N95 or other standards for particulate filtration, liquid barrier protection, resistance to high-intensity heat source/ flammable gas, or infection prevention. It is not intended to be used as a respirator or in such a clinical setting where the risk level of infection through fluids or inhalation exposure is high. This mask has not been tested for effectiveness against the COVID-19 virus. Each mask is intended for use by one person only and must not be shared. See instructions for use and cleaning on Marena.com.
Contact: For more information, please contact:
Jonathan Kott
202-316-7895
jkott@Tuskstrategies.com
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SOURCE The Marena Group
