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N95 designated by NIOSH causes continued shortage of new supply of surgical N95

Newport, Virginia News, November 16, 2021/PRNewswire/ - Today, ivWatch, LLC, a leading biosensor medical device manufacturer that detects intravenous infiltration and extravasation events, was awarded the National Institute of Occupational Safety and Health ( NIOSH), part of the Centers for Disease Control and Prevention (CDC), produces surgical N95 respirators. The new name allows ivWatch to produce blox surgical N95 respirators at the company's Hampton Road headquarters under the approval number TC-84A-9379 to help close the gap in the shortage of surgical N95 respirators. Unlike industrial N95 respirators, surgical N95 respirators are specifically designed and tested for medical and healthcare purposes.

The blox surgical N95 respirator (BLX-9501) is specifically designed and tested for medical and healthcare purposes.

ivWatch has been committed to the development of top surgical N95 respirators manufactured in the United States from the beginning, using locally sourced materials and manufacturing in the company's domestic FDA-registered factory. BLX-9501 has undergone extensive procurement requirements and performance testing to ensure compliance with the highest quality and standards of 42 CFR 84. After a year of development and application and third-party verification, the company was awarded NIOSH designated tests from Nelson Labs and Pacific Biolabs. ivWatch has a mature quality management system (QMS), which has passed the ISO 13485 global certification under the MDSAP program since 2018. An effective QMS is a key aspect of any reputable medical device organization.

Gary Warren, President and CEO of ivWatch, said: “We are proud to be one of the few authentic American manufacturers to be designated as NIOSH surgical N95 respirators. “Our company’s foundation in engineering and mathematics allows us to use our The biosensor machinery effectively creates a new security solution that can play an important role in protecting our community. Just like when we fasten our seat belts when we get in the car, we are entering a time to call for better respirators as the safety and protection standards of our hospital system. It is necessary; our respirators should put counterfeit and inferior N95 in In the rearview mirror. "

This designation came when countries, states, municipalities, hospitals, airlines and retail stores around the world reassessed or, in some cases, re-enacted mask regulations. Some people went even further and banned the use of low-quality cloth masks. Hospitals in some parts of the country are also constantly in need of valuable and real PPE when they reach ICU capacity or are expected to have an influx of highly infectious patients.

"Our manufacturing, quality and regulatory teams have been working closely with NIOSH-from concept to design to final production-to obtain approval for surgical N95 respirators. Considering that we have entered the COVID-19 pandemic for two years, we are honored Dr. Jaclyn Lautz, Chief Operating Officer of ivWatch, said: “At a critical moment, high-filtration masks may become a catalyst for reversing this deadly global pandemic. "

The blox products are powered by the vQuality system, an interactive database designed to combat low-quality and counterfeit respirators that flood the market. vQuality publishes the online test performance data of each batch of respirators. The blox Surgical N95 respirator has been analyzed and tested and meets industry standards. Hospitals still need reliable, authentic, comfortable and affordable respirators.

The blox Surgical N95 respirator has been tested to ensure that the filtration efficiency exceeds 95%1, and it has a comfortable and safe fit and a 360-degree seal, which can extend the wearing time. The blox Surgical N95 respirator complies with CDC's tuberculosis exposure control guidelines and is fluid resistant-a key requirement for respirators approved for use in medical, surgical, and clinical settings.

During the development phase, blox's unique pleated design was specifically designed and manufactured to pass the hospital fit test protocol. The blox surgical N95 respirator was tested by a third party by Nelson Laboratories. Performance test results include:  

Customers can visit: blox.ivwatch.com/product for more information and view detailed test reports.

To purchase blox high-performance products, customers can purchase directly on BloxDirect.com. The blox surgical N95 respirator (BLX-9501) can also be ordered in bulk and can be purchased by contacting [email protection].

1 Nelson Laboratories. "Sodium Chloride (NaCl) Aerosol Test Report" (Study No. 1404015-S01). April 2021.

About blox and vQuality blox is a high-fidelity particulate filter mask and surgical N95 respirator product line supported by ivWatch, LLC, which designs, manufactures and supplies biosensor medical equipment for hospitals and facilities worldwide. In order to meet the influx of counterfeit and below-average masks and respirators, ivWatch uses its R&D expertise and manufacturing capabilities in the healthcare industry to manufacture high-quality particulate respirators that have passed vQuality sealing and system verification. vQuality is the company's identity verification platform that provides customers with transparency in product performance data through easy-to-access simplified reports, which highlights the outstanding performance of blox. 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 the first to use optical sensors to detect adverse IV events early to minimize the risk of injury due to infiltration and extravasation. By using this technology, clinicians can use continuous monitoring to help identify infiltration as early as possible. Our innovative IV monitoring solution is supported by decades of clinical research and device development. To learn more, follow us on Twitter @ivWatch, Facebook @ivWatchLLC and LinkedIn @ivWatch-LLC, or visit www.ivWatch.com. 

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