The range of gloves available includes latex and nitrile gloves, sterile and non-sterile gloves, and gloves of different lengths. Some terms related to gloves are more specialized. Here’s a simple guide to help you avoid headaches as we all try to understand glove standards and complex technical terms.
1. Cleanrooms, may not be what you think
In this case, a clean room is not the result of a chore. Clean Air Technology defines it as a controlled environment with low levels of pollutants such as dust, airborne microorganisms, aerosol particles and chemical vapors. Our partner Shield Scientific explains that cleanroom products are classified according to the number and size of particles allowed in each volume of air.
Larger numbers, such as Class 100, refer to Federal Standard 209E (FS 209E) and specify the allowable number of particles per cubic foot of air ≥ 0.5µm. The ISO 14644-1 standard uses a smaller number representing the fractional logarithm of the allowed number of particles per cubic meter of air ≥ 0.1µm. ISO Class 5 cleanroom gloves contain at least 105 particles per cubic meter.
Shield Scientific acknowledges on its website that there is no internationally recognized standard limit for determining whether a cleanroom glove is ISO Class 4 or ISO Class 5. Therefore, SHIELDskin Xtreme™ gloves are branded based on how many times the product has been washed in deionized water:
- DI: Deionized water for a single wash.Basic pollution control. 3000 particles/cm²≥0.5µm
- DI+: Three washes with deionized water.High pollution control. ≥0.5µm per cm² = 1200 particles
- DI++: Wash multiple times with deionized water.Extreme pollution control. 850 particles/cm²≥0.5µm
2. Complex Design-Don’t be too complicated to understand
Class III or “complex design” gloves protect against chemicals and microorganisms.
This category includes the highest risk levels: irreversible and lethal risk. According to Shield Scientific, the following references may apply to these types of gloves.
- EN 420:2003 + A1:2009 = General requirements for gloves
- ISO 375-5:16 = Terminology and performance requirements for biological risks. EN 374-2:2014 (see below) remains the basic test for assessing resistance to penetration by microorganisms.
- ISO 374-1:2016 = Terminology and performance requirements for chemical risks. ISO 374-1:2016+A1:2018 supersedes en374-1:2003, chemical penetration testing remains the same, but chemical degradation testing is also carried out.
An outside organization, known as a Notified Body, must regularly audit products to verify the quality assurance system used by the manufacturer. This is according to an article by Nick Gardner. Their presence is evident on the 4-digit number that appears on the glove packaging under the CE marking.
3. AQLs, pinholes and microbial barriers
Contaminants carried by humans use pinholes as passages through gloves. The Acceptable Quality Level (AQL) is a parameter for evaluating the pinhole barrier performance of a glove. EN 374-2:2014 is based on AQL for testing the resistance of microorganisms to penetration.
There are three tiers on top of AQL, outlined below:
Level Aql
- <0
- <1.5
- <0.65
If the AQL is less than 0.65, it is assumed that up to 0.65% of the product in any batch has pinholes. With AQL less than 1.5, it is assumed that up to 1.5% of the product in any batch has pinholes. This means gloves with lower AQLs offer greater protection.
4.Gloves; Barrier against chemicals, viruses and electrostatic discharge
Shield Scientific explains in their Guide to Chemical Protection that EN 16523-1:2015 + A1:2018 is used to assess the chemical protection properties of gloves.
EN 16523-1:2015 will replace EN 374-3:2003. EN 374-2:2003 indicates that gloves are tested for their ability to penetrate chemicals and/or microorganisms.
ISO 16604:2004 Procedure B and ASTM F1671-97b address biological risks.
Gloves with these reference materials prevent contact with blood and body fluids.
Their resistance to blood-borne pathogen penetration was tested using Phi-X174 phage. ISO 16604:2004 Procedure B is sometimes referred to as virus penetration testing. This is according to ISO and ASTM websites.
EN 1149-1-2-3 and 5 cover the electrostatic properties of gloves. Different sections of this standard are necessary due to differences in application areas and materials.
According to ROOTS, section:
- Covers test methods for measuring surface resistivity
- Test methods for measuring resistance through materials
- Test methods involving the measurement of charge decay
- is about material properties and design requirements
5. Last but not least: the Medical Device Directive
the Directive for Medical Devices and Accessories specifies the conditions that must be met in order to be approved for the application of the CE marking.
There are three instructions. 90/385/EEC deals with medical devices that use electrical power and remain in the human body.
98/79/EEC covers products for the in vitro detection of human derived substances.
The Medical Devices Directive 93/42/EEC covers medical devices and accessories not covered by other directives. It can be divided into four categories based on risk factors and the intended use of the glove. Class I is low risk, class II (a or b) is moderate risk, and class III is high risk.
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