IvWatch Receives NIOSH Approval to produce surgical N95 respirators, addressing the ongoing shortage of these vital healthcare implements. The medical device manufacturer, known for its biosensors that monitor IV infiltration and extravasation events, received the designation from the National Institute for Occupational Safety and Health (NIOSH) after a year-long development and application process. The approval allows ivWatch to produce blox Surgical N95 Respirators at its Hampton Roads headquarters. Designed for medical and healthcare use, these respirators underwent rigorous testing to meet the highest quality standards. Gary Warren, President and CEO of ivWatch, expressed pride in the company’s achievement and emphasized the significant role this new safety solution can play in protecting communities.

Introduction

N95 Designation from NIOSH Leads to New Authentic Supply of Surgical N95s that Continue to be in Shortage

NEWPORT NEWS, Va. — ivWatch, LLC, a leading medical device manufacturer of biosensors that detect IV infiltration and extravasation events, received approval from the National Institute for Occupational Safety and Health (NIOSH), a part of the Centers for Disease Control and Prevention (CDC), to produce surgical N95 respirators. The new designation allows ivWatch to produce blox Surgical N95 Respirators, under approval number TC-84A-9379, at the company’s Hampton Roads headquarters to help close the gap in the surgical N95 respirator shortage. Unlike industrial-use N95 respirators, surgical N95 respirators are designed and tested specifically for medical and healthcare use.

Development and Approval

ivWatch worked from the beginning to develop a pinnacle surgical N95 respirator made in the USA, with locally sourced materials and manufactured at the company’s domestic FDA registered facility. BLX-9501 underwent extensive sourcing requirements and as-made performance testing to ensure the highest of quality and standards in compliance with 42 CFR 84. The company was awarded NIOSH designation following a year-long development and application process as well as third-party validation testing from Nelson Labs and Pacific Biolabs. ivWatch has an established Quality Management System (QMS) that has been globally certified to ISO 13485 under the MDSAP program since 2018. An effective QMS is a critical aspect to any reputable medical device organization.

Company Statement and Impact

“We are proud to be one of only a handful of U.S.-based, authentic manufacturers to receive surgical N95 respirator designation from NIOSH,” said Gary Warren, President and CEO of ivWatch. “Our company’s foundation in engineering and mathematics allowed us to leverage our biosensor machinery to effectively create a new safety solution that can play a major role in protecting our communities. Just like we put seatbelts on when we get into a car, we are entering a time where a call for better respirators as the standard for safety and protection is necessary for our hospital systems; our respirators should put counterfeit, inferior N95s in the rearview mirror.”

Product Features and Testing

blox Surgical N95 Respirators are tested to ensure greater than 95% filtration efficiency1 and are built for extended wear times with a comfortable, secure fit and a 360-degree seal. blox Surgical N95 Respirators meet CDC guidelines for tuberculosis exposure control and are fluid resistant – critical requirements for respirators approved for medical, surgical, and clinical environments.

In the research and development phase, blox’s unique pleated design was specifically engineered and manufactured to pass hospital fit testing protocols. blox Surgical N95 Respirators were third-party tested by Nelson Labs. Performance test results include:

  • Synthetic blood penetration resistance up to 160mmHg per ASTM F1862
  • Inhalation resistance (complete respirator): 7.3 (mm H2O)
  • Exhalation resistance (complete respirator): 9.4 (mm H20)
  • Flammability rating: Class I per 16 CFR 1610

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

Availability and Contact Information

To purchase blox high performance products, customers can buy direct at BloxDirect.com. blox Surgical N95 Respirators (BLX-9501) are also available in bulk orders and can be purchased by contacting sales@ivWatch.com.

About blox & vQuality
blox is a product line of high-fidelity particulate filtration face masks and surgical N95 respirators backed by ivWatch, LLC that designs, manufactures, and supplies biosensor medical devices to hospitals and facilities worldwide. Seeking to fill a need swarmed by counterfeit and below average face masks and respirators, ivWatch leveraged its research and development expertise in the healthcare industry and its manufacturing prowess to create superior high quality particulate respirators verified by the vQuality seal and system. vQuality is the company’s authentication platform that provides transparency about product performance data to customers in an easily accessible, simplified report, which underscores 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 adverse IV events early to minimize the risk of injury caused by infiltrations and extravasations. By using this technology, clinicians can leverage 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 learn more, follow us on Twitter @ivWatch, Facebook @ivWatchLLC, and LinkedIn @ivWatch-LLC, or visit www.ivWatch.com.

SOURCE ivWatch, LLC

Question & Answer

What approval did ivWatch receive recently?

ivWatch received approval from NIOSH to produce surgical N95 respirators.

Where will ivWatch be producing the blox Surgical N95 Respirators?

ivWatch will be producing the blox Surgical N95 Respirators at its Hampton Roads headquarters.

What are some key features of the blox Surgical N95 Respirators?

The blox Surgical N95 Respirators are tested to ensure greater than 95% filtration efficiency, have a comfortable and secure fit, and meet CDC guidelines for tuberculosis exposure control.

How can customers purchase blox Surgical N95 Respirators?

Customers can purchase blox Surgical N95 Respirators directly at BloxDirect.com or in bulk orders by contacting sales@ivWatch.com.