Posted on by Tom Travin
We get a lot of questions about the difference between exam- and industrial-grade gloves.
We also get a lot of questions about Acceptable Quality Level, or AQL. What is it, and how does it apply to disposable gloves?
These questions are all related, and are among the most frequent we get from distributors and end users alike.
Let’s start here: What is the difference between exam- and industrial-grade gloves?
It’s simple, but with nuance
To put it as simply as possible, exam- and industrial-grade gloves vary in quality, specifically in the number of manufacturing defects per batch of gloves. But there is more nuance to it than that.
Differentiation is based on the AQL rating established by the American National Standards Institute, or ANSI. It’s an international standard that gauges the likely percentage of pinhole defects in a batch of gloves.
Those conducting the tests fill gloves from a particular production batch with 1,000 ml of water. The gloves are then suspended, with fingers pointing down, and examined for leaks. In a batch of 100 gloves with an AQL of 3.0, only three gloves in that batch can fail the test. More than three, and the entire batch is rejected.
The industrial glove standard
An AQL of 3.0 to 4.0 is used for industrial gloves, while exam-grade gloves are held to a higher standard of 2.5 or lower. That means that fewer than 2.5 gloves in a batch of 100 can fail. There is no guarantee that gloves rated 2.5 or lower are perfect, but they are as close as they can be.
Under standards developed by the American Society for Testing and Materials—ASTMD6319,D5250, andD3578—the minimum AQL requirement is set at 2.5 for exam-grade gloves. The U.S. Food and Drug Administration’s requirement is also AQL 2.5, per21 CFR 800.20 (c)(2).
One fact that might surprise glove users is that glove makers typically manufacture exam- and industrial-grade gloves on the same production line. Although industrial gloves also pass standard quality testing by the manufacturer, they are not required to undergo testing for medical purposes.
Safety is always what matters
Does a higher AQL mean gloves aren’t safe? Not at all. Many industrial gloves, particularly those made of nitrile, afford excellent protection against chemicals and hazardous substances. Simultaneous production is simply an efficient way for manufacturers to produce both types of gloves while delivering appropriate quality.
Exam-grade nitrile gloves require registration as aClass I medical devicewith the U.S. Food and Drug Administration. Registration was eliminated for exam-grade latex and vinyl gloves. Nitrile registration requires the AQL test, accompanied by AQL and ASTM documents.
AMMEX carries a wide selection of exam- and industrial-grade gloves in nitrile, latex, and vinyl. Check out ourproduct catalogfor an overview of our brands.
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