What is Leaky Can be Risky: A Study of the Integrity of Hospital Gloves

There is a need for the Food and Drug Administration to establish more stringent guidelines for manufacturing gloves and to verify compliance with these guidelines.

Abstract

One thousand six-hundred and eighteen medical gloves were tested to determine whether, with current increased demands, these gloves are of high quality, i.e., free of leaks. The risk of exposure to potentially infected fluids when using leaky gloves was also estimated. Using a four-stage leak test, no significant difference was found between 64 of 790 (8.1%, range 0% to 44.4%) unsterile latex gloves and 11 of 210 (5.2%, range 1.7% to 21.7%) unsterile vinyl gloves (p = .21). Sterile surgical gloves (7 of 618, 1.13% [range 0% to 3%]) had fewer leaks compared to unsterile latex and vinyl gloves combined (p less than .0001). The safranin test was positive in 27 of 28 (96.4%) leaky gloves tested, indicating a high risk of exposure to potentially infected fluids when leaky gloves are used. Because of these findings, elements of "universal precautions" such as changing gloves after each patient contact and good handwashing after using gloves should be carefully observed. There is a need for the Food and Drug Administration to establish more stringent guidelines for manufacturing gloves and to verify compliance with these guidelines.