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What Are The Differences Between Medical Grade and Industrial Grade Disposable Gloves?

September 11, 2022345 ViewsGloves8

In the Industrial workplace, the overall answer is no difference. The gloves are generally made on the exact same machines with the exact same formulation and, therefore, the same performance. So, for use in general work environments in tasks such as food service, janitorial, automotive, manufacturing, assembly, poultry or agricultural applications, you can use either a disposable glove labeled as “Industrial Use Only” or a disposable glove labeled as “Medical Examination” glove.

However, it is not just the same glove in a different box. When it comes to Medical Use, there is a difference. The difference is in the Acceptable Quality Limit or AQL. The lower the AQL, the more stringent the glove is inspected for defects such as pinholes.

The difference is that the Quality Control and Quality Assurance testing levels are more stringent for Medical Exam Grade gloves. The AQL, or Acceptable Quality Limit, for Medical Exam Gloves (Class One Medical Devices) must be 2.5 or lower. Simply put, this means there has to be less than 2.5 defects in a batch of 100 gloves to pass. The facility where the glove is made must be authorized by the US Food and Drug Administration with a 510K License Agreement to produce Class One Medical Devices. This license is granted after a stringent auditing process of Good Manufacturing Practices performed periodically by FDA.

FDA requires that the AQL for an Industrial Disposable glove can be 4.0 or less for defects such as cosmetic blemishes and holes. For a Medical Examination glove, it must be 2.5 or less. Many Exam gloves are manufactured at an AQL of 1.5 or even lower, which is even better.

The best way of remembering what AQL stands for is this: FDA sets a LIMIT on what is ACCEPTABLE for the number of defects allowable in a glove labeled as an exam glove. The LIMIT is 2.5 or lower. If our QUALITY CONTROL finds more than 2.5 defects such as holes in a batch of gloves, that is above the LIMIT and is NOT ACCEPTABLE. Steps must be taken to remedy the QC issue.

Anything less than the ACCEPTABLE QUALITY LIMIT of 2.5 is even better. An AQL of 1.5 means very good quality and minimal risk of a hole where Bloodborne Pathogens or other dangerous drugs, such as Fentanyl Citrate or other materials might penetrate and expose the skin of the hands.

You should not use a glove labeled as “Industrial Use Only” with an AQL of 4 in a situation where body fluids or dangerous drugs may be encountered. On the other hand, using a Medical Exam Glove with an AQL of 1.5 in an Industrial setting means a higher level of quality and protection and enhanced safety.