Before disposable gloves can be sold or used, they undergo a thorough inspection after they’ve been finished and dried. Hand protection is the primary requirement for gloves, whether they are used with harsh chemicals or in medical applications where bloodborne pathogens may be present.
For exam-grade gloves to be considered safe, they need to pass a series of tests set by the U.S. Food and Drug Administration. The gloves undergo abrasion, tension, and elongation tests, as well as chemical resistance tests.
An FDA-set acceptable quality limit (AQL) guides glove inspection. The American Society conducts AQL tests for Testing and Materials (ASTM), which creates standards for industries worldwide.
Glove Quality Levels are percentages of each batch of gloves. The AQL of 3.0 allows only three gloves per batch to fail the test (Medical gloves must have an AQL of 1.5 or lower). The entire batch is not acceptable if more than three gloves fail the test. A manufacturing process review will be conducted in this situation to determine what needs to be adjusted.
While all glove manufacturers strive to meet the FDA guidelines, they may miss a few by a small margin if the ASTM test does not pass. That means that if the glove does not pass the ASTM test, it is not considered “approved” by the FDA. Medical-grade gloves have a lower AQL number due to the risks associated with the field.
During glove quality testing, several inspections are carried out. Medical gloves are suitable for medical applications based on testing for barrier integrity, such as the pinhole leak test. Even the slightest breach can expose pathogens to gloves. This test involves filling the gloves with water, closing the cuffs, and hanging them upside down. To be approved for medical applications, gloves cannot leak.
It does not necessarily mean that a glove is unsafe if it is not officially “approved.” Industrial and medical gloves are typically produced on the same line. Industrial gloves are often almost medical-grade when you buy them. Surgical gloves, which have been irradiated, are the only gloves considered sterile. Exam gloves are not sterile.