Medical Gloves Quality Monitoring During the Year 2009 – 2011

Abstract

         During the year 2009 – 2011, the Bureau of Radiation and Medical Devices monitored the quality of medical gloves for post – marketing surveillance. A total of 258 samples; 211 samples of examination gloves were tested following Thai Industrial Standard (TIS) 1056 B.E. 2548, and 47 samples of surgical gloves were tested following Thai Industrial Standard (TIS) 538 B.E. 2548. The physical requirements were dimensions of palm width length and thickness, watertightness, tensile properties. The results that the non-conformity of examination gloves and surgical gloves was found to be 30% and 13% respectively. The major cause of non-conformity were watertightness, force at break and elongation at break. The risk of non-conformity from watertightness is more important than from force at break and elongation at break for medical personnel. Consequently, the quality control of medical gloves should be further monitored for safety of consumer.