American PAPR Receives Full Approval From NIOSH for High Efficiency (HE) PAPR
NEW YORK, Jan. 27, 2021 /PRNewswire/ -- American PAPR LLC, a New York City-based manufacturer, today announced that it has received full approval from the National Institute for Occupational Safety and Health (NIOSH) for the FELIX-200, a loose-fitting, powered air-purifying respirator (PAPR) with a High Efficiency (HE) classification. The FELIX-200 is the second PAPR released by the manufacturer. The FELIX-100 was deployed across the nation early in the response to the pandemic in 2020.
PAPRs are respirators that protect the user by filtering out 99.97% of contaminants in the air. It uses a battery-powered blower and custom filter to provide the user with clean air. In addition to the battery, filter, and blower unit, the FELIX-200 has a loose-fitting hood with a visor.
"As a start-up company based in New York City — the U.S. ground zero of the COVID-19 pandemic — we are proud to provide protection to the hard-working health care workers putting themselves at risk each day to serve the public during this crisis," said Daniel Cohen, Ph.D., CEO and Founder of American PAPR. "The American PAPR team appreciates the challenging emergency conditions that first responders, healthcare workers, and government agencies (such as NIOSH and FDA) have endured as they work to protect both COVID-19 patients and those who treat them."
The ease of airborne SARS-CoV-2 transmission has resulted in a surge in hospitalizations across the country, resulting in a well-documented shortage of personal protective equipment (PPE), especially respiratory protection, for healthcare workers and emergency responders. The benefits of PAPRs include reusability, comfort for the wearer due to the loose-fitting nature and cooling effect from the flowing air, as well as the elimination of fit testing requirements. The use of PAPRs can provide higher levels of protection compared to N95 masks and also offset the critical supply shortages of these masks.
"We are particularly grateful for the outstanding service offered by NIOSH throughout the approval process," said Cohen. "Their responsiveness to us was impressive, and made all the more notable given the more than 100-fold increase in their workload during this pandemic. Their individual and team efforts are deeply aligned with the commitment to protect workers."
The approval process required a qualification review by NIOSH's National Personal Protective Technology Laboratory (NPPTL) which included both an inspection of manufacturing facilities and quality assurance processes. American PAPR gained FELIX-200 NIOSH full approval with a perfect site qualification score. This is a testament to American PAPR's strict quality standards. American PAPR is now one of only 14 U.S. companies holding NIOSH full approval for PAPRs.
About the FELIX-200 PAPR
The FELIX-200 provides a minimum of 99.97% filter efficiency against airborne particles. It has received full NIOSH approval under Federal Regulations for Public Health Title 42, Part 84.
About American PAPR LLC
American PAPR LLC, a fully owned subsidiary of 3DBio Therapeutics, is a personal protective equipment manufacturer based in New York City, and recently moved their HQ and manufacturing facility to a new space at the Brooklyn Navy Yard. American PAPR meets the industry's strictest quality standards per 42 CFR Part 84 and is committed to providing high quality, state-of-the-art respiratory protection to medical professionals.
3DBio Therapeutics
3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that manufactures living tissues to treat patients. 3DBio has developed unique capabilities toward the creation of living tissue implants for therapeutic applications. The technology platform includes a full suite of features to meet the FDA's requirements for therapeutic manufacturing, including novel and proprietary 3D-bioprinter (GMPrint™), bio-ink (ColVivo™), and cell processes. In preclinical studies, the platform has demonstrated the ability to generate functioning living tissues.
Certain information set forth in this press release may constitute "forward-looking statements" under applicable securities laws. There are a number of factors that could cause actual results or outcomes to differ materially from those addressed in such forward-looking statements. Thus forward-looking statements are provided only as an opportunity to understand management's beliefs and opinions in respect of the company's future prospects.
SOURCE American PAPR
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