Periodic Reporting for period 2 - SafeGlov (Safety Gloves for Protection of Health Care Professionals)
Reporting period: 2020-12-01 to 2021-11-30
As a world debut, Smarterials integrates a double-layer into a single glove, which is innovative in terms of simplification, comfort and safety. The Two-in-One gloves integrate a sandwich layer to provide multi-barrier protection and an indicator, warning the user in case of breach. Gloves from these new materials provide unrivalled donning and wearing comfort. At the same time, production and use are more resource efficient and can be made cheaper compared to existing double gloving systems. The patent- pending invention builds on large-scale available substances of tailor-made material components.
The development was driven by a spec sheet mapping the market demand. On the technical side, Smarterials made a huge step towards the final product: the materials, more precisely Smarterials’ suspension, has been fine-tuned and scaled-up in three subsequent snapshots. A robotic dip-coating system was built to adapt the technology for high-frequency lab production and detailing the dipping process parameters of the manufacturing process, i. e. times and temperatures for industrial steps carried out during manufacturing, facilitating the step to the pilot and subsequent production lines. This activity was also identified as an additional business area, since requests from other companies for the robotic setup have been received.
Among others, the laboratory environment for testing and ensuring the quality of the R&D activities covers tests of the perforation indicator and needle puncture testing as well as properties and safety of the product. On the regulatory side, Smarterials’ interdisciplinary team is constantly managing and assessing the actual results, costs and planning via a documenting communication and within its design reviews. Smarterials is also setting a quality management system (QMS) in accordance with EN ISO 13485:2016.
Smarterials develops a product to literally add an extra layer of safety for healthcare professionals, protecting those from blood and body fluid contamination as well as chemotherapeutics and similar pharmaceuticals. The objectives of the SME Instrument Ph II project are to realize Smarterials’ next big milestones: transfer of Two-in-One gloves onto production lines, certify the product as a medical device class IIa to finally launch the product in early 2023. Our gloves are one element to increase the safety of health care personal during work, keep health care workers healthy themselves and thereby protect the integrity of the health care systems. In addition, the Two-in-One gloves will replace the need to wear two gloves, thereby substantially reducing the amount of waste from disposable medical products