fr
es
de

Understanding glove standards

Complex Design covers the highest level of risk, otherwise defined as irreversible and mortal risk. Disposable gloves in this category are typically those gloves that provide protection against chemical splashes and microorganisms. For these gloves the following normative references may apply: EN 374-1:2003 (terminology and performance requirements), EN 374-2:2003 (resistance to penetration by chemicals and microorganisms), EN 16523-1:2015 (supersedes EN 374-3:2003 – resistance to permeation by chemicals), EN 388:2003 (mechanical risks) and EN 420:2003 + A1:2009 (general requirements for gloves).

Crucially complex design brings the need for regular auditing by an external organization body, called a Notified Body.  The presence of the Notified Body is clearly evident, as under the CE mark will appear four digits (e.g. 0120 = SGS, 0493=Centexbel, 0321=Satra, 0123=TÜV etc): Figure 2. The Notified Body validates the quality assurance system used by the manufacturer.

Figure 2 showing CE mark for Complex Design glove with four digits

In addition, disposable gloves that have been registered as Complex Design will typically display two or three pictograms identifying the relevant standards to which they have been tested (Table 1):

Table 1: Different pictograms and their respective standards

EN 374-3:2003

 

Tested for protection against chemical permeation

                
Low chemical resistant or waterproof gloves.                

EN 374-2:2003

 

Tested for protection against liquid penetration and micro-organisms

 

              

 

EN 388:2003

 

Tested for protection against mechanical risks (abrasion, blade cut resistance, tear resistance & puncture resistance)

 

                 

Unlikely to be displayed as few if any disposable gloves will achieve performance level rating of more than zero

 

Instructions for use

                 

EN 16523-1:2015 (supersedes EN 374-3:2003) (determination of resistance to permeation by chemicals).

This glass beaker pictogram (Figure 3) can only be displayed if a breakthrough time of at least thirty minutes (permeation performance level: 2) has been achieved in three of the twelve listed chemicals (Table 2). The code letters of the three tested chemicals must feature below the pictogram. With the exception of some of the thicker gauge gloves, no standard thin gauge disposable glove in the commonly encountered materials is likely to achieve the required level 2 in three out of the twelve listed chemicals.

Figure 3 – chemical pictogram for chemical protective glove  

Table 2 – List of test chemicals

Code letter Chemical CAS N° Class
A Methanol 67-56-1 Primary alcohol
B Acetone 67-64-1 Ketone
C Acetonitrile 75-05-8 Nitrile Compound
D Dichloromethane 75-09-2 Chorinated paraffin
E Carbon disulphide 75-15-0 Sulphur containing organic compound
F Toluene 108-88-3 Aromatic hydrocarbon
G Diethylamine 109-89-7 Amine
H Tetrahydrofurane 109-99-9 Heterocyclic and ether compound
I Ethyl acetate 141-78-6 Ester
J n-Heptane 142-85-5 Saturated hydrocarbon
K Sodium hydroxide 40% 1310-73-2 Inorganic base
L Sulphuric acid 96% 7664-93-9 Inorganic mineral acid

Table 2 – Permeation performance levels

Measured breakthrough time Permeation performance level
>10 minutes 1
>30 minutes 2
>60 minutes 3
>120 minutes 4
>240 minutes 5
>480 minutes 6

Figure 4 – chemical pictogram for waterproof and low chemical protective gloves

 

To highlight the limitations of the chemical barrier properties of standard thin gauge disposable gloves and to emphasize that these gloves are designed only for incidental exposure to chemical splashes, there is also a chemical pictogram for waterproof and low chemical protection gloves (Figure 4).  Significantly there is no obligation for the manufacturer to undertake any testing on the twelve listed chemicals.

Figure 5 – pictogram for micro-biological hazards

 

EN 374-2:2003 (determination of resistance to penetration by chemical and/or micro-organisms through porous material).

For most disposable gloves, the water leak test is used, where according to the inspection level based on ISO 2859 a specified number of gloves from every batch are filled with water to assess the levels of pinholes. Levels of pinholes are measured in terms of AQL or Acceptable Quality Level, with an AQL of 0.65 having a lower level of acceptable pinholes than 4.0. To display the pictogram (Figure 5) and as part of the process for satisfying a Complex Design registration, gloves must have a minimum AQL of 1.5. EN 374-2:2003 describes the levels, which are often displayed underneath the pictogram (Table 3).

Table 3 Inspection levels and AQL outlined in EN 374-2:2003

Performance level Acceptable quality level (AQL) unit Inspection levels
Level 3 <0.65 G1
Level 2 <1.5 G1
Level 1 <4.0 S4

EN 388:2003 (Protective gloves against mechanical risks)

The pictogram (Figure 6) can only be displayed if the glove achieves a performance level rating of one in at least one of the four specific tests (Table 4).

Figure 6 – pictogram for mechanical risks

Table 4 Levels of performance for assessing protection against mechanical risks

Test Level 1 Level 2 Level 3 Level 4 Level 5
Abrasion (number of cycles) 100 500 2000 8000
Blade cut resistance (factor) 1.2 2.5 5.0 10.0 20.0
Tear resistance (N) 10 25 50 75
Puncture resistance (N) 20 60 100 150

This post is also available in: French, German, Spanish

Categorised in: Glove education

Categories

Latest posts

ANALYTICA 2018

Munich, Germany:  10.04.2018 -13.04.2018 – You find us at Hall A3 / Booth 208 München, Deutschland: […]

LAB INNOVATIONS 2017

Meet SHIELD Scientific at Lab Innovations 2017. STAND B13 November 1st – 2nd 2017 National Exhibition […]

BIOTECHNICA 2017

Hannover, Germany:  16.05.2017 -18.05.2017 – You find us at Hall 019 / Booth D86 Hannover, […]

THE CLINICAL PHARMACY CONGRESS

Meet SHIELD Scientific at The Clinical Pharmacy Congress. STAND C8 May 12th – 13th 2017 […]

GLOVING IN RNAse-FREE ENVIRONMENT

It is generally acknowledged that RNA is more prone to degradation than DNA, which may […]