Revisiting Latex Gloves in Healthcare - A Post-Market Clinical Study

Abstract

Sterile Surgical Gloves are worn to prevent contamination of the patient during invasive procedures and they help prevent surgical site infections and reduce the risk of exposure to blood and body fluid pathogens for the healthcare worker. The purpose of the study was to evaluate the safety and performance of Sterile Latex Surgical Gloves- Powdered and Powder Free, Sterile Latex Gynaecological Gloves- Powdered and Powder Free. Overall, 976 subjects participated in the study, out of which sterile latex surgical gloves were used by the users in 288 cases. Sterile latex surgical gloves powder free was used by users in 291 cases. Sterile Latex Gynaecological Gloves Powdered were used by users in 201 cases and Sterile Latex Gynaecological Gloves Powder Free was used in196 cases. From the clinical safety parameter analysis, sterile latex surgical gloves were safe to use and none of the users reported safety-related issues. The overall rating given by the user for product performance was excellent for all the products. All the users agreed that the product is meeting the product quality. The overall rating given by the user for product satisfaction is Excellent. None of the users have reported any undesirable events. Keywords: gloves, latex, allergy, healthcare workers