ivWatch Receives NIOSH Approval for Blox N95 Surgical Respirators, Adding to Domestic N95 Manufacturers Restricted List for Medical Use and Only Company to Produce in Virginia

ivWatch worked from the start to develop an advanced N95 surgical ventilator manufactured in the United States, using locally sourced materials and manufactured in the company’s national FDA-registered facilities. The BLX-9501 has been subjected to extensive sourcing requirements and performance testing as performed to ensure quality and the highest standards, in accordance with 42 CFR 84. The company has received the NIOSH designation as a result. a one-year development and application process as well as third-party validation. test of Nelson Laboratories and Pacific Biolabs. ivWatch has an established Quality Management System (QMS) that has been globally ISO 13485 certified under the MDSAP program since 2018. An effective QMS is a critical aspect for any reputable medical device organization.

“We are proud to be one of the few genuine manufacturers based in the United States to receive the NIOSH N95 Surgical Respirator designation,” said Gary Warren, President and CEO of ivWatch. “Founding our company in engineering and math has allowed us to leverage our biosensor machines to effectively create a new security solution that can play a major role in protecting our communities. Just as we buckle up our seat belts when we get into a car, we enter a time when a call for better respirators as a standard of safety and protection is needed for our hospital systems; our respirators should put inferior N95s in the rearview mirror. ”

The designation comes as countries, states, municipalities, hospitals, airlines and retail stores around the world reassess or, in some cases, reinstate mask warrants. Some even go further and ban inferior fabric masks. Hospitals in some parts of the country also have a continuing need for genuine and valuable PPE as they reach critical care capacity or anticipate influxes of highly contagious patients.

“Our manufacturing, quality and regulatory teams worked rigorously with NIOSH – from concept through design to final production – to gain approval for the N95 surgical respirator. Given that we have been two years into the COVID-19 pandemic, we are honored to be approved by NIOSH at a critical time when high-filtration respirators could be the catalyst to turn the tide against this deadly pandemic through the world, ”said Jaclyn Lautz, PhD, director of operations at ivWatch.

Blox products are backed by the vQuality system, an interactive database designed to tackle shoddy and counterfeit respirators that have flooded the market. vQuality exposes online test performance data for each lot of respirators. The N95 blox surgical respirator has been analytically tested to comply with industry standards. The need for reliable, authentic, comfortable and affordable respirators for hospitals remains.

Surgical N95 blox respirators are tested to ensure filtration efficiency greater than 95%1 and are designed for extended wear times with a comfortable, secure fit and 360 degree waterproofness. N95 blox surgical respirators meet CDC guidelines for controlling exposure to tuberculosis and are fluid resistant – essential requirements for respirators approved for medical, surgical and clinical environments.

During the research and development phase, blox’s unique pleated design was specifically designed and manufactured to pass hospital fit test protocols. Blox N95 surgical respirators have been third party tested Nelson Laboratories. Performance test results include:

  • Synthetic resistance to blood penetration up to 160 mmHg according to ASTM F1862
  • Resistance to inhalation (full respirator): 7.3 (mm H2O)
  • Resistance to expiration (full respirator): 9.4 (mm H2O)
  • Flammability index: Class I according to 16 CFR 1610

Customers can learn more and view detailed test reports by visiting: blox.ivwatch.com/product.

To purchase high performance blox products, customers can purchase directly from BloxDirect.com. Blox N95 Surgical Respirators (BLX-9501) are also available in bulk orders and can be purchased by contacting [email protected].

1Nelson Laboratories. “Sodium Chloride (NaCl) Aerosol Test Report” (Study Number 1404015-S01). April 2021.

About blox and vQuality
blox is a product line of high fidelity particle filtration face masks and N95 surgical respirators backed by ivWatch, LLC which designs, manufactures and supplies biosensor medical devices to hospitals and facilities around the world. Seeking to address a swarming need for counterfeit and sub-par face masks and respirators, ivWatch has leveraged its healthcare research and development expertise and manufacturing prowess to create particulate respirators. high quality verified by vQuality seal and system. vQuality is the enterprise authentication platform that provides customers with transparency into product performance data in a streamlined, easily accessible report that highlights blox’s superior performance. To learn more, visit blox.ivwatch.com.

About ivWatch, LLC
ivWatch, LLC is a biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. Our dedicated and passionate team is pioneering the use of optical sensors to detect unwanted IV events early to minimize the risk of injury from infiltration and extravasation. Using this technology, clinicians can take advantage of continuous monitoring to help identify infiltrations as early as possible. Our innovative IV monitoring solutions are backed by decades of clinical research and device development. To find out more, follow us on Twitter @ivWatch, Facebook @ivWatchLLC, and LinkedIn @ ivWatch-LLC, or visit www.ivWatch.com.

SOURCE ivWatch, LLC

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