MOUNT AIRY, N.C., Sept. 23, 2020 /PRNewswire/ -- United Sewing Automation, Inc. (USA) today announces the test results of their ASTM Rated Level 3 Disposable PPE face masks produced in their new automated manufacturing facility in Mount Airy, N.C. With the continued spread of the Coronavirus, safety remains a top priority in America. While face masks have become a key component in fighting the spread of the virus, not all face masks provide optimal protection. As a result, USA recently completed extensive testing of their American-sourced and manufactured face masks in an ISO 17025 accredited laboratory and is pleased to report excellent results.
ASTM International sets the preferred international standard in healthcare best practices inclusive of testing and requirements for performance of medical grade materials. The FDA, who oversees the sale and marketing of all surgical masks, requires that manufacturers demonstrate mask performance in several critical areas: Bacterial Filtration, Particulate Filtration, Liquid Barrier Protection, Breathability, and Flammability.
USA is pleased to announce the following test results:
- BFE – ASTM 2101 Bacterial Filtration Efficiency – passed at 99.62%
- PFE – ASTM F2299 Particulate Filtration Efficiency – Rated Over 99.76%
- Fluid resistance ASTM F1862 – passed at 160 mmHg
- Flammability 16CFR 1610 – Passing Results for Class 1
- Differential Pressure ASTM F2101-19 Breathability – Passed at 4.8 mm
- Biocompatibility – Non-cytotoxic and Non-irritating
With testing complete, USA's American-sourced and manufactured masks are now in compliance with the Berry Amendment and qualify for Department of Defense contracts.
Since the onset of the Coronavirus pandemic, America's reliance on imported PPE has caused supply chain issues. In addition, the United States has been flooded with cheap, imported, inferior-quality face masks that do not provide adequate protection to fight the spread of COVID-19. In response, USA's ownership team invested in automated equipment to manufacture American-made medical grade masks that provide proper protection for Americans.
Made from high-quality, USA-sourced materials, USA's face masks feature a three-ply design with a built-in adjustable nose bridge and ear loops made of nylon and Spandex, providing a better fit than traditional disposable masks.
"We are very happy with the new test results," said Ben Webb, USA's CEO. "Our goal is to provide the highest-quality protective masks for every face in America every time one is needed. This virus is highly contagious and the American public needs to better understand that not all masks provide the proper protection. These test results prove that our masks provide a higher level of protection than lower-quality, imported masks. We want to do our part in controlling the spread of this highly contagious airborne virus."
USA's ownership team has many years of experience in the textile and apparel industry and had the vision in 2017 to bring apparel manufacturing back to Mount Airy, N.C. through automation. USA recently installed high-tech Ultrasonic welding machines and automated production equipment capable of producing 1,000,000+ facemasks per week, with the ability to expand to meet market demand.
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About ASTM International
Organized in 1898, ASTM International is one of the world's largest international standards developing organizations. ASTM standards and defined and set by the organization itself and help improve the lives of millions every day. Combined with its innovative business services, these standards enhance performance and help everyone have confidence in the things they buy and use - from the toy in a child's hand to the aircraft overhead. By understanding commercial needs and consumer priorities, ASTM touches every part of everyday life - helping our world work better.
About The Berry Amendment
The Berry Amendment Compliance is a federal regulation that requires Department of Defense funds to be spent on U.S. manufactured items in order to protect the United States industrial market during times of war.
The Berry Amendment is intended for companies that wish to acquire Department of Defense contracts. This amendment applies to products such as food, clothing, tents, materials, and tools. Some exceptions include if the product is unavailable from a U.S. source, purchasing from allies, perishable food or emergency items for personnel located outside of the United States, and purchases at or below the simplified acquisition threshold. These determinations can only be made by specific officials who must provide supporting documentation.
Companies wishing to obtain compliance must guarantee that their products (including all components) are 100 percent domestic.
About United Sewing Automation
United Sewing Automation, Inc., USA, manufactures Face Masks, Product Code QKR, OXZ and FXX for use by the General Public or Healthcare Professionals in accordance with FDA's Immediate in Effect Guidance (May 2020) to address the Coronavirus Disease 2019 (COVID-19) public health emergency. Due to the significant shortage of Personal Protective Equipment (PPE) caused by the COVID-19 pandemic, USA is proud to provide High-Quality, Single-Use, Disposable Face masks made in our facility located in Mount Airy, North Carolina, U.S.A also known as Mayberry, the fictional town made famous by Andy Griffith.
SOURCE United Sewing Automation