After the disposable gloves have been made and dried, they are thoroughly inspected before being packed and sold. Gloves’ essential necessity, whether in industrial applications involving harsh chemicals or medical applications involving potential exposure to bloodborne infections, is that users’ hands be covered to be protected. To meet the US Food and Drug Administration’s safety criteria, exam-grade gloves must pass several tests. Gloves are puncture and abrasion resistant, have their tension and elongation evaluated, and have their chemical resistance evaluated. The FDA has established acceptable quality limits (AQL) for glove inspection. The American Society for Testing and Materials (ASTM), which establishes standards for industries all over the world, developed AQL testing procedures. The AQL method is a percentage-based method that applies to sample of gloves. For example, in a sample of 100 gloves with an AQL of 3.0, only three gloves can fail the test. (The AQL for medical-grade gloves is 2.5 or less). If more than three gloves fail to satisfy the criteria, the entire sample fails. Manufacturers will examine the manufacturing process in this situation to see what needs to be changed. A lower AQL number represents a higher quality product.
The FDA does not consider a glove to be “approved” if it fails the ASTM tests; however, it may be “accepted.” This implies that, while all glove manufacturers strive to comply with FDA regulations, a few may fall short. The AQL score for medical-grade gloves is lower due to the hazards in the medical industry. Various inspections are performed during glove quality testing. The pinhole leak test establishes if gloves are suitable for medical uses by checking for barrier integrity. Even the smallest crack in the glove’s material might allow viruses to enter. Manufacturers fill the gloves with one liter of water, close the cuffs, then hang the gloves upside down in this test. Gloves that do not leak during the testing process are approved for medical use.
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It doesn’t mean a glove isn’t safe just because it isn’t formally “certified.” The term “sterile” does not apply to exam gloves. Surgical gloves that have been irradiated are the only ones that are considered sterile.
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