Questionnaire-based evaluation of the safety, usability, and performance of trupoly powder-free sterile latex surgical gloves

Background: The primary goal of surgical gloves has been to aid in the attainment of aseptic conditions during a surgical procedure, assuring a higher level of protection for both the surgeon and the patient. The advent of transmissible diseases such as hepatitis B and C, and HIV, as well as the implementation of universal precautions in health-care, has prompted healthcare personnel to be concerned about their own safety, resulting in an increase in the use of latex gloves. Methodology: The objective of this study was to evaluate the safety and performance of Trupoly gloves by assessing the incidence of allergic reactions and usability in terms of manual dexterity, tactile sensitivity, handgrip strength, muscle activity, comfort level during usage and product complaints/issues. The questionnaire was distributed among healthcare professionals to provide their feedback and experience with the use of Trupoly gloves. Result: The clinical investigation was initiated on April 10, 2021 and completed on July 10, 2021. 395responses from participating health care professionals were considered for assessment of safety and performance of the device. The results from the safety variables assessed in this Post Marketing Clinical Follow-up study indicate that about 1.01 percent of users experienced allergic reactions typical of surgical gloves made of powder-free latex. For the majority of factors related to the comfort and convenience of using Trupoly gloves, more than 85% of users reacted with scores of 04 and 05 (most comfortable). Conclusion: The results from this study demonstrates both the safety and performance of Trupoly gloves.