The Acceptable Quality Level (AQL) is a statistical unit of measure and a forecasting indicator of the quality of a product. It applies to all types of production in batches to ensure the production process meets the required standards. Medical devices, for example, must always be produced to a very high standard of quality. Surgical and examination gloves are an essential protective barrier and neither you, nor your patients, would be willing to deal with a defective glove, however rarely this can happen. When the gloves are produced, the production process cannot guarantee a “zero defect” product. Post-production controls are very rigid and established by international standards. AQL testing for gloves watertight serves to identify the maximum number of gloves with micro imperfections in a given lot, according to a standard inspection level. The smaller the number of non-compliant samples, the lower the AQL of the examined gloves.

Before you can determine the AQL of a type of gloves, one must identify the Lot Size (number of gloves produced in terms of pieces) which in turn will determine the number of samples to be analyzed and the General Level of Inspection that is established at Level 1 in accordance with the ISO 2859-1 for examination gloves. In order to be certified as medical devices, gloves must have an AQL ≤1,5. The test determining the AQL of a glove is a watertight test. The gloves are hung upside-down and filled with about 1000ml of water each at a temperature between 15° and 35°C. Gloves are visually checked for 2-3 minutes; if they can hold the water, they are considered suitable. On a production lot of 50.000 pieces and for a General Level of inspection 1, the batch samples to be analyzed are 200 pieces. To obtain an AQL of 0.65, the number of non-compliant samples must not be more than 3.