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.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial