Knowledge Center

AQL for Gloves

Glove inspection is based on acceptable quality limits (AQL). For this product the U.S. Food and Drug Administration sets this standard,and the testing methods for AQL are from the American Society for Testing and Materials (ASTM), a firm that creates standards for various industries across the world.

AQL (Acceptable Quality Level) usually refers to the product’s impermeability absence of holes (gloves), but may also refer to other features such as strength external appearance. This is also a limit of average permissible faults in the production process. The level determined based on the quantity of defective products in the tested sample. AQL is not expressed as a %. The lower the AQL the lower the likelihood of a defective product.

Since disposable gloves apply in multiple fields, they must undergo strict inspections before they are ready for sale. In the automotive, sanitation, and agricultural industries, workers (will) handle some irritating chemicals,which means that the gloves they wear must prove (can) provide adequate protection. The same goes for medical applications (gloves), where employees need to have a safe barrier against pathogens.

Therefore, manufacturers use extensive testing to determine which glove application is suitable, while gloves have different requirements of the standard.

Quality Standards

The AQL test is divided into medical gloves and industrial gloves (two levels). Medical-grade gloves have higher AQL standards. In the concerns of the risks in the medical field, AQL sets a lower figure for medical-grade gloves.

AQL is a method that applies to batches of gloves and functions as a percentage. For example, in a batch of 100 gloves with an AQL of 4.0, only four gloves in the batch can fail the test. For medical-grade gloves the AQL is 1.5 or lower. If more than three gloves fail, the entire batch does not meet the standard In this case, manufacturers will review the manufacturing process to determine what requires adjustment.

Glove quality testing involves various inspections. The pinhole leak test, which checks the barrier integrity,is used to determine whether the glove is suitable for medical applications or not. This is because even if the smallest breach in glove material could make wearer exposed to pathogens. In this test, the manufacturer fills the gloves with one liter of water, closes the cuffs of the gloves, and hangs the gloves upside down. Gloves that do not leak during the test are suitable for medical-grade applications.

Strictly Check and Require Every Detail to be Accurate

An interesting fact about disposable gloves and AQL is that manufacturers usually produce medical grade and industrial grade gloves on the same production line. Although industrial-grade gloves also pass the manufacturer’s standard quality tests, while they do not need to undergo FDA testing for medical purposes.

To separate glove type as medical and industrial grade is simply a cost-efficient way for manufacturers to produce both types of gloves by appropriate level of quality, instead of implying the latter one as below safe quality.