Methods for the mechanical testing of medical gloves
According to DIN EN 455-1, a water leak test can be performed to verify the watertightness of disposable gloves. Using a vertical tube, 1000 ml of water at a temperature between 15 °C and 35 °C is filled into the glove to be tested. The glove is immediately visually inspected for leaks. The glove is considered non-watertight as soon as water leakage occurs. After 2 to 3 minutes, the glove is visually inspected again.
According to DIN EN 455-2, the dimensions and the tensile strength of a medical disposable glove are determined. At least 13 samples per glove batch are used. For dimensional verification, the glove length and width are measured using a ruler and compared with the size table specified in the standard.
Depending on the intended use of the gloves, different dimensional requirements apply. For determination of tensile strength, dumbbell-shaped specimens are punched from the palm area of the gloves. The single wall thickness of the glove and the thickness of the dumbbell specimen are measured. The statically determined tensile force is multiplied by the ratio of single wall thickness to specimen thickness. The resulting tensile force value is then compared with the values specified in the standard.
The gloves are stored in consumer packaging for the intended shelf life at a temperature specified by the manufacturer. Afterwards, the gloves are tested for watertightness according to EN 455-1 and for tensile strength according to EN 455-2. The integrity of the packaging and the suitability of the gloves for their intended use are also verified. The shelf life corresponds to the time at which all specified tests are still successfully passed.
