NIOSH Grants Advoque Safeguard Full Conventional Approval for Model ASG100 N95 Respirator
California company will produce NIOSH-approved N95 respirators using filtration materials sourced from U.S. manufacturers
SANTA CLARA, Calif., Feb. 11, 2021 /PRNewswire/ -- Advoque Safeguard today announced that its model ASG100 N95 Particulate Filtering Respirator has been approved by the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) under approval number TC-84A-9284.
"Following a robust testing and approval process, our ASG100 respirators have now earned full conventional NIOSH approval," said Paul Shrater, Chief Business Officer. "All of us at Advoque Safeguard are honored to contribute to the supply of personal protective equipment and are grateful to our front-line workers who have been relentlessly supporting our communities throughout this pandemic. We are also grateful to CDC's dedicated NIOSH staff for their oversight and communication throughout the regulatory process. We look forward to ramping up production and delivering our high-quality products to those who need them most."
Advoque Safeguard will produce the NIOSH-approved ASG100 respirators at its 80,000 square-foot ISO-9001-certified factory in Santa Clara, California, using base materials sourced in the United States. The company expects to produce millions of units on a weekly basis.
"The conventional approval process is highly involved, focusing not only on the product and its construction, but heavily on the quality control processes and documentation of these processes throughout the production cycle," said Chief Technical Officer Jason Azevedo. "Obtaining our global ISO9001 quality certification prior to obtaining the conventional approval was a significant step in preparing for the NIOSH approval process."
In addition to the ASG100 N95 respirator, Advoque Safeguard is pursuing research and development of additional respirator models, and expects to pursue regulatory approval of these additional respirator models this year. Each respirator model is subject to its own NIOSH review and approval process.
The approval status of model ASG100 N95 respirators can be validated by checking the specific model number on the NIOSH website.
About Advoque Safeguard
Advoque Safeguard is a spinoff of Advoque, a contract manufacturer with a 10-year record of producing high-quality goods, from custom packaging to industrial control panels. Advoque Safeguard operates out of an 80,000 square-foot, ISO-9001-certified factory in Santa Clara, California, where it produces personal protective equipment (PPE) from base materials sourced from U.S. manufacturers. Advoque Safeguard was launched in spring 2020, to address the PPE shortage driven by the COVID-19 pandemic. Since then, more than 600 workers have helped produce face shields, masks, and respirators, designed to help people work safely in hazardous environments.
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SOURCE Advoque Safeguard
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