How manufacturers detect the quality of disposable medical glove?

Publish Time: 2018-05-08     Origin: Pidegree Group

Given the many uses for disposable medical glove, they must undergo rigorous inspection before they are ready for sale. In the automotive, janitorial-sanitation and agricultural industries, workers deal with a number of harsh chemicals, which means the gloves they wear must be proven to provide the right amount of protection. The same is true for medical applications, where employees need a safe barrier against pathogens.

As such, manufacturers use extensive testing to determine which applications glove is appropriate for, with medical-grade gloves having higher standards.Here's an overview of the process:

Standards for minimum quality

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 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 3.0, only three 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.

Testing methods for gloves

Glove quality testing involves various inspections. The pinhole leak test, which checks for barrier integrity, is one that determines whether gloves are suitable for medical applications. This is because even the smallest breach in the glove material permits wearers from exposure to pathogens. In this test, manufacturers fill the gloves with one liter of water, close the gloves at the cuff and hang the gloves upside down. Gloves that do not have leaks during the testing period are acceptable for medical applications.

One interesting fact about disposable glove testing and AQL is manufacturers typically produce medical-grade and industrial-grade gloves on the same line. Although industrial-grade gloves also pass standard quality testing by the manufacturer,they are not required to undergo FDA testing for medical purposes.

This is not to say industrial-grade gloves are not of safe quality, but it is simply cost-efficient way for manufacturers to produce both types of gloves while providing the appropriate level of quality. Medical-grade gloves have higher AQL standards.


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