Assessment of safety, usability and performance of sterile latex surgical glove pre-powdered of Healthium Medtech limited: a survey study based on questionnaire
Keywords:Allergic reaction, Anaphylaxis, Handgrip strength, Latex surgical gloves, Tactile sensitivity
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.
FDA. Medical gloves. FDA. https://www.fda.gov/medicaldevices/personalprotectiveequipmentcontrol/medical-gloves. Accessed on 20 March 2022.
Marie Hartley. Surgical gloves, 2010. Available at: https://dermnetnz.org/topics/surgical-glo. Accessed on 30 January 2022.
Korniewicz DM, El-Masri MM, Broyles JM, Martin CD and O'Connell KP. A laboratory-based study to assess the performance of surgical gloves. AORN J. 2003;77(4):772-9.
Medical glove. Wikipedia, the free encyclopedia, 2022. Available at: https://en.wikipedia.org/wiki/Medical_gl. Accessed on 30 January 2022.
Huber MA, Terezhalmy GT. Adverse Reactions to Latex Products: Preventive and Therapeutic Strategies. J Contemp Dent Pract. 2006;(7)1:097-106.
Double gloving-A standard of practice in surgery for healthcare practitioners. Available at: https://www.ansellhealthcare.com/pdf/edPro/FINAL%20CE_DoubleGloving_UK_tg%20edits_V10compressed.pdf. Accessed on 15 January 2022.
Korniewicz DM, Garzon L, Seltzer J, Feinleib M. Failure rates in nonlatex surgical gloves. Am J Infect Control. 2004;32(5):268-73.
Filon FL, Radman G. Latex allergy: a follow up study of 1040 healthcare workers. Occup Environ Med. 2006;63(2):121-5.
Hamann CP, Turjanmaa K, Rietschel R, Siew C, Owensby D, Gruninger SE, et al. Natural rubber latex hypersensitivity: incidence and prevalence of type I allergy in the dental professional. J Am Dent Assoc. 1998;129(1):43-54.
Leung R, Ho A, Chan J, Choy D, Lai CK. Prevalence of latex allergy in hospital staff in Hong Kong. Clin Exp Allergy. 1997;27(2):167-74.
Tanner J, Parkinson H (2006). Double gloving to reduce surgical cross-infection. Cochrane Database Systematic Rev. 2006;(3):CD003087.