Assessment of safety, usability and performance of sterile latex surgical glove pre-powdered of Healthium Medtech limited: a survey study based on questionnaire

Abstract

Background: Medical gloves worn during patient examinations and procedures aids in the reduction of cross-contamination between healthcare professionals and patients. Gloves have to be strong enough to protect the wearer and comfortable enough not to choke the hand of the user. The aim of the study was to assess the incidence of allergic reactions, usability, and performance of Truskin gloves (Sterile latex surgical glove pre-powdered). Methods: The objective of this study was to evaluate the safety and performance of Truskin 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. Consent was obtained from all the participants (healthcare professionals from various hospitals across India) involved in the study. The questionnaire was distributed among healthcare professionals to provide their feedback and experience with use of Truskin gloves. Results: The clinical investigation was initiated on April 10, 2021 and completed on July 10, 2021. Responses from 472 participating health care professionals were considered for assessment of safety and performance of Truskin gloves. The results from the safety variables assessed in this study indicate that about 5.51% users had experienced allergic reactions typical of powdered latex surgical gloves. More than 80% users have responded with a score of 04 and 05 (most comfortable) for all the variables associated with comfort and convenience of usage of Truskin gloves. Conclusions: The results from this study demonstrates both the safety and performance of Truskin gloves.