The FDA sets high standards to ensure the disposable gloves you purchase here in the U.S. perform as expected and provide an adequate barrier for their intended use. To meet these standards, glove manufacturers have tight quality controls and manufacture gloves according to ASTM specifications and testing requirements.
A key quality measurement that glove manufacturers publish on glove boxes, bags and product literature is AQL, or Acceptable Quality Level.
Stated as a percentage, the AQL is a statistical measurement of the quality of the gloves. An AQL of 2.5% means that statistically, only 2.5 gloves for every hundred gloves will fail a quality test.
How AQL is Determined
Let’s say a glove manufacturer produces 10,000 gloves from the same material, settings and processes. Two hundred gloves would be pulled randomly from the line, throughout the batch, to be tested. To meet an AQL of 2.5%, no more than 10 gloves can fail the quality tests. If more than 10 gloves fail, the entire batch fails, and each glove must be tested individually for quality, or else the whole batch is discarded. An AQL of 1.5% would mean that no more than 7 gloves could fail.
ASTM D5151 Test for Detection of Holes in Medical Gloves
Disposable gloves are subjected to numerous ASTM tests throughout the manufacturing process. One test that medical and cleanroom gloves have in common is a test for pinholes.
ASTM D5151 is the Standard Test Method for Detection of Holes in Medical Gloves, often referred to as the “watertight” test or “water leak” test. In this test, the gloves are each filled with 1000 ml of water at room temperature, secured at the cuff and hung vertically for two minutes to check for pinholes. If water does not leak from the glove, it gets a “pass.”
The current FDA mandated maximum AQL for examination and cleanroom gloves on this test is 2.5%, down from the previous 4.0% prior to December 2008. Some gloves, however, are manufactured and tested to meet the lower AQL of 1.5% required for surgical gloves. This means higher quality and fewer pinholes.
