Face masks supplier United Sewing Automation Inc (USA) revealed on Wednesday that its ASTM Rated Level 3 Disposable PPE face masks produced at its new automated manufacturing facility in Mount Airy, NC is in compliance with the Berry Amendment and qualify for Department of Defense contracts following an extensive testing in an ISO 17025 accredited laboratory in the fight against COVID-9.
The US FDA, which oversees the sale and marketing of all surgical masks, requires that United Sewing must demonstrate mask performance in several critical areas: Bacterial Filtration, Particulate Filtration, Liquid Barrier Protection, Breathability and Flammability.
Based on the FDA requirement, the company's masks passed bacterial filtration efficiency of 99.62%, particulate filtration efficiency of 99.76%, fluid resistance at 160 mmHg, Class 1 flammability of 16CFR 1610, differential pressure at 4.8mm as well as achieved non-cytotoxic and non-irritating biocompatibility.
According to the company, the masks are made from high-quality, USA-sourced materials as well as 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.
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