There are two types of testing gloves must go through. Firstly, gloves must meet regulatory requirements to be certified as medical grade before they can go onto the market. Once these requirements are met, each batch of gloves is given simpler tests afterward to ensure quality is being maintained.
For batch testing, gloves are tested first by being filled with air, then by using the pinhole leak test according to ASTM standards. Although all gloves have pinholes, the test ensures the pinholes aren’t big enough to allow fluid to reach the skin. Workers fill the gloves with a liter of water and watch for two minutes for leaks. Industrial glove batches have to meet an acceptable quality limit, or AQL, of 1.5%, which statistically means that only 1.5 gloves per 100 can fail the test. Having less 1.5 gloves per 100 fail means the gloves are of higher quality and can be used in medical applications.
Besides the tests that must be performed on each glove batch, there are regulatory tests to prove the gloves being manufactured are safe enough to merit a medical rating. Besides the tests that must be performed on each glove batch, there are regulatory tests to prove the gloves being manufactured are safe enough to merit a medical rating.
All gloves must pass a dimension test, in which the glove must meet requirements for the length between the cuff and middle fingertip and the width of the palm, as well as a certain thickness requirement. These measurements depend on glove size and type. Gloves must also pass sterility tests in line with the guidelines in the U.S. Pharmacopeia, and aging tests, which require a glove to meet tensile and elongation performance standards after being heated at 70 degrees C and 100 degrees C for a certain number of hours. Powder amount must also be less than 2 mg per glove. Latex gloves must also pass additional tests for aqueous extractable protein content and antigenic protein content.
ASTM is currently making its testing standards for PPE available for free to help companies producing vital supplies during the pandemic. You can register to read the standards on their website.
The FDA has also temporarily cut down on some of the requirements to approve medical gloves for manufacturing, as long as companies send a premarket 510k notification, the product follows ASTM standards, and the gloves are properly labeled. More information can be found on their website www.surgicalgloves.com.
