Disposable Glove Guide

What to Consider When Buying Disposable Gloves

Disposable Gloves Thickness & Length

3 mil - 8 mil is the most common range of glove thicknesses

• Medical grade gloves have lower thicknesses and a corresponding increased dexterity
• Thicker gloves (4 - 5 mil) are more suited to industrial environments
• 8 mil+ gloves are ideal when you need extra protection from corrosive chemicals or other hazardous evironments.
• Longer gloves also provide additional protection such as disposable nitrile gloves with 12" extended cuffs

Disposable Glove Color

Disposable glove color is generally preferential based on the industry and application

• Black disposable gloves are used in industrial applications to hide dirt or blood (think tattoo artist).
• Varying colors are used to differentiate between departments in food processing. This can prevent cross contamination and if a foreign material is found in the product, it can be traced back to the source
• Disposable gloves in medical applications are most often blue or indigo

Powdered vs. Powder-Free Disposable Gloves

• Powdered disposable gloves have cornstarch added to make donning and removal easier, especially in busier environments. Powdered gloves have raised concerns about exacerbating latex allergies or sticking to hands, surfaces, or clothing after use.
• Powder Free disposable gloves go through a process called chlorination, making them less form fitting and easier to don and remove. This process can reduce grip and make them harder to remove quickly.

Disposable Glove Grade & Standards

Glove Grade is determined by measuring Acceptance Quality Limit or AQL. AQL is the measurement of the percentage likelihood of pinhole defects in a batch of disposable gloves. A predetermined number of gloves from a batch are selected and tested for water tightness - or leakage. The AQL rating represents the percentage of gloves per hundred that leaked in a batch of disposable gloves.

Example:

• Disposable gloves rated with a 1.5 AQL have 1.5 defects per 100 gloves
• Surgical gloves require an 0.65 AQL or lower
• Medical Gloves & Exam require a 1.5 AQL or lower
• Industrial grade gloves require a 4.0 AQL or lower

What's the difference between a medical and exam grade disposable gloves?

• They are the same. Medical exam grade gloves can be referenced three ways - Exam, Medical, or Medical Exam Grade. All three labels are correct and equal. To use this label, gloves must be manufactured with a 1.5 AQL or lower at an FDA authorized 510(k) facility.

What is a 510(k) for exam grade disposable gloves?

• A 510(k) is a document approved by the FDA that allows medical devices to be introduced into commercial distribution.
• Exam/Medical grade gloves are regulated by the FDA as Class I reserved medical devices that require a 510(k) premarket notification.FDA - Medical Gloves 510(k)

How can I tell if a glove is rated for food contact?

• Food service gloves or food prep gloves are certified under FDA Title 21 CFR Part 177, stating that the material components of the glove comply with the FDA regulations and the gloves consist of “Substances generally recognized as safe for use in food or food packaging.”

How can I tell if a disposable glove is rated for use with chemotherapy?

• If a glove is rated safe for use during chemotherapy that means it has been determined as compliant under USP 800 and ASTM D6978-0
• These are standards for the handling of hazardous drugs to minimize the risk to the personnel handling them.
• Gloves are approved by testing them for permeation against the various hazardous drugs used during chemotherapy.

How can I tell if a disposable glove is rated for cleanroom use?

• Cleanroom gloves are rated for use using the ISO 14644-1:2015 classification system. This system creates classes of “clean” based on measured airborne particulates per cubic meter - numbered ISO 9 down to ISO 1 (cleanest).
• Gloves specifically designed for these special applications are carefully laundered, tested and packed/labeled by the manufacturer to ensure a particle count that is compatible with the cleanroom environment where they will be used.