Ensuring the right protective, single-use gloves are chosen for cleanroom tasks has been made simpler via a series of industry standards and symbols. Karen Rossington* offers a guide to the symbols, their meaning and relevance to EU PPE standards
Pictograms are used routinely in modern life, from signs for toilet locations to road signs, safety instructions on planes to identifying hazards. Their purpose is to remove language barriers and they are used throughout the healthcare environment. They also form part of the packaging requirements for gloves classed as Personal Protective Equipment (PPE). But in this instance, not all the pictograms are completely self-explanatory without some understanding of the standards.
There are two European directives that relate to PPE. The Use of Personal Protective Equipment Directive 89/656/EEC1 relates to the obligations of an employer with regard to the protection of the employee. Three key articles within this directive identify the responsibility of the employer with regard to identification and evaluation of risk; PPE should be the last resort if the risk cannot be reduced or eliminated by the modification of a workplace practice. The employee should be informed of the risk and provided with the appropriate, well-fitting PPE that complies with EU standards. Items of PPE should be issued to employees free of charge with clear instructions for use.
Article 5 of this directive places the responsibility with the employer to analyse and assess the risks involved, define the characteristics of the PPE needed, compare the merits of the various types of protection available and verify that the chosen items of PPE conform to the EU regulations. This audit of risk should be repeated if there is a change in a process or introduction of a new drug or chemical.
Personal Protective Equipment Directive 89/686/EEC2 applies to the PPE itself and lays down conditions governing its placement on the market. The objectives of the PPE directive are to provide the basic health and safety requirements that the PPE must satisfy to preserve the health and ensure the safety of the intended users and also ensure free movement within the European Community. All PPE placed on the market in EU Member States must comply with Directive 89/686/EEC and carry the CE Marking.
PPE directive 89/686/EEC allocates products into three distinct groups. These are named in the directive as “Simple design”, “Complex design” and neither of these, the latter being the third category. It is common practice to refer to these as category I, III and II respectively.
PPE classified as Category I is “PPE of simple design where the designer assumes the user can assess the level of protection provided against the minimal risks concerned…” For gloves, this would cover gardening, oven and janitorial gloves that could be used with “cleaning materials of weak action and easily reversible effects”.
PPE classified as Category III is “of complex design intended to protect against mortal danger or against dangers that may seriously or irreversibly harm the health, the immediate effects of which the designer assumes the user cannot identify in sufficient time”. For gloves, this would include those designed to protect against chemicals, radiation, mechanical or thermal/cold risk or micro-organisms.
This leaves PPE classified as Category II, which covers all PPE not covered in either Category I or III. This may also be referred to as intermediate design or medium risk. Single-use, thin gauge gloves almost always fall into either Category I or III.
For gloves in PPE Category I, the manufacturer is permitted to test and certify the gloves themselves. They will meet the requirements of EN420:2003 + A1:2009, Protective gloves – General requirements and test methods.3 These gloves will be identified with the simple CE mark (i).
Gloves in PPE Category II must be tested independently and issued with a type-testing certificate by a Notified Body in accordance with Article 10 of the Directive. They must carry a simple CE mark either on the gloves or their packaging when this is not practical. The name and address of the Notified Body that issued the Article 10 certificate must appear on the instructions for use that accompany the gloves.
Pictogram ii
Gloves in PPE Category III must also be tested and undergo a full technical file review by a Notified Body. In addition, the quality assurance system used by the manufacturer must also be independently checked either by the routine type testing of finished product by the Notified Body or by regular Notified Body audits. This surveillance is carried out in accordance with Articles 11a or 11b, respectively. The Notified Body that carries out this assessment is identified by a unique number, which must appear alongside the CE mark. As an example, 0120 in the pictogram (ii) is the Notified Body Number for SGS United Kingdom Ltd.
There is a range of standards that apply to gloves to be used as PPE. All gloves must meet the requirements of EN420:2003 General requirements for protective gloves. Additionally, there are risk-specific standards that must be applied. The standard that is most appropriate to single-use thin gauge cleanroom gloves is EN 374:2003 Parts 1–3 Protective gloves against chemicals and micro-organisms.4 EN 374 requires that manufacturers also declare results to EN 388:2003 Protective gloves against mechanical risk.5
Pictogram iii
EN 420:2003 +A1:2009 Protective gloves – general requirements and test methods: This standard defines the general requirements for glove design and construction, innocuousness, comfort and efficiency, marking and information applicable to all protective gloves. The standard also applies to gauntlets and arm guards used on separative devices. The scope of the standard highlights that it does not cover the protective properties of a glove and that it should be used in combination with standards such as those listed above.
Marking of the glove or packaging: The standard states that gloves should be marked with the name or trademark of the manufacturer, the glove and size designation (product code), date of obsolescence (if relevant), the CE mark and the relevant pictograms relating to the above mentioned standards. The pictogram should be accompanied by a reference to the applicable standard and the relevant performance levels, which should always be in the same order as defined in the standard.
If marking on the glove is not possible, marking can be affixed to the packaging
It does give the caveat that, if marking on the glove is not possible in view of the characteristics of the product, marking can be affixed to the packaging. This will be the case for most thin gauge, single-use gloves.
The standard acknowledges that the pictograms alone are not sufficient to convey the comprehensive information about protection required by the end user and they should only be considered alongside the additional information supplied by the manufacturer.
The packaging should also include the manufacturer’s full address, reference to where further information can be obtained and if the glove is of simple design, the phrase “For minimal risk only” should be shown.
Additional information
The following additional information should be supplied when the protective glove is placed on the market and should be maintained and made available on request: the size range available, the reference to the relevant EN Standards, care and storage instructions, and the instructions for use.
If the glove protects only a certain part of the hand this needs to be clear on the packaging, as does any other in-use warning. A list of substances contained in the glove that are likely to cause allergies should be shown and a full list of substances contained in the glove should be made available on request.
The relevant pictograms indicating the categories of hazard followed by the applicable performance level should be shown and a basic explanation should be given to assist in the comprehension of the relevant performance levels. For example, from standard EN 407:2004, Protective gloves against thermal risk, 6 there are six categories of hazard which must be passed, with performance levels from 1–4, with 4 being the highest (see Fig.1).
Figure 1: For thermal risk, there are six categories of hazard that must be assigned performance levels from 1–4
EN 374:2003 Protective gloves against chemicals and micro-organisms: This standard specifies the requirements of the gloves to protect the user against chemicals and micro-organisms. It specifically looks at the penetration of chemicals or micro-organisms through porous material, seams, pinholes or other imperfections in a protective glove at a non-molecular level. It also looks at permeation – the process by which a chemical moves through a protective glove material at a molecular level.
The time taken for the test chemical to pass through the glove material from initial exposure to its presence on the other side of the material at a specific flow rate is known as the breakthrough time. This is the parameter that is used to determine the resistance of a glove material to a chemical. Under EN 374, breakthrough is deemed to have occurred when the flow rate reaches 1µg/cm2/min.
When assessing the suitability of a glove for its intended use, the performance of the material against permeation of chemicals (including cytotoxics) needs to be considered alongside the proposed duration of use/exposure.
Three pictograms can be displayed to reflect results against EN 374. The “chemical resistant” flask pictogram (iii) can be shown with a minimum three-digit code underneath if a glove material has achieved at least a permeation performance level 2 when tested against three of the 12 chemicals shown in Table 1.
| Table 1: List of predefined test chemicals in BS EN 374 | |||
| Predefined chemical in EN 374 | Class | CAS* number | Code letter |
| Methanol | Primary alcohol | 67-56-1 | A |
| Acetone | Ketone | 67-64-1 | B |
| Acetonitrile | Nitrile compound | 75-05-8 | C |
| Dichloromethane | Chlorinated paraffin | 75-09-2 | D |
| Carbon disulphide | Sulphur containing organic compound | 75-15-0 | E |
| Toluene | Aromatic hydrocarbon | 108-88-3 | F |
| Diethylamine | Amine | 109-89-7 | G |
| Tetrehydrofurane | Heterocyclic and ether compound | 109-99-9 | H |
| Ethyl acetate | Ester | 141-78-6 | I |
| n-Heptane | Saturated hydrocarbon | 142-85-5 | J |
| Sodium hydroxide 40% | Inorganic base | 1310-73-2 | K |
| Sulphuric acid 96% | Inorganic mineral acid | 7664-93-9 | L |
| *Chemical Abstracts Services registration number. A division of the American Chemical Society. | |||
| Table 2: Permeation performance levels detailed in EN 374 | |
| Performance Level | Measured Breakthrough Time (MBT) |
| Level 1 | Minimum 10 mins |
| Level 2 | Minimum 30 mins |
| Level 3 | Minimum 60 mins |
| Level 4 | Minimum 120 mins |
| Level 5 | Minimum 240 mins |
| Level 6 | Minimum 480 mins |
| Table 3: Acceptance quality levels (AQL) and inspection levels from ISO 2859 | ||
| Performance Level | Acceptance quality level | Inspection levels |
| Level 3 | <0.65 | G1 |
| Level 2 | <1.5 | G1 |
| Level 1 | <4.0 | S4 |
Level 2 performance is a breakthrough time of a minimum of 30 mins, (Table 2). The glove will have also passed the penetration test, and an air and water leak test as detailed in EN 374-2. The performance level is determined by the required inspection level and the AQL as shown in Table 3.
Pictogram iv
Gloves that fail the permeation tests against three of the 12 listed chemicals but pass the penetration tests may be marked with the open beaker pictogram (iv). The flask and open beaker pictograms cannot be used together on the same glove. The pictogram is intended to indicate a lower level of protection.
The “micro-organism” pictogram (v) can be used when a glove passes the penetration test to at least level 2 performance. It must be remembered, however, that this relates only to bacteria and fungi, not to viruses.
Pictogram v
An “i” must be shown below the flask to indicate that details of the permeation test are available unless the open book with an “i” pictogram is used from EN420.
EN 374 also states that the mechanical characteristics of the glove should be declared in the manufacturer’s instructions. These are results against abrasion resistance, blade cut resistance, tearing resistance and puncture resistance, as described in EN 388 Protective gloves against mechanical risks. Few, if any, thin gauge gloves will pass these particular tests. A tested item is given a performance rating of 1–4 (lowest to highest). An X is used to show a test that was not performed. Pictogram (vi) is taken from a latex glove showing it managed a level 1 result against abrasion resistance (more than 100 cycles to abrade through the test glove), no level achieved for blade cut and no tests carried out for tearing or puncture.
Pictogram vi
In conclusion, the pictograms for PPE standards should always be read in conjunction with further information, which must be made available from the manufacturer.
Further thought should also be given to what the pictograms are really telling us. For instance, some PPE gloves of complex design are required to be labelled with the open beaker pictogram (indicating low level protection) just because the chemicals they are designed to protect against are not on the prescribed list. This would be the case for gloves designed to be used for protection against cytotoxic drugs where they may achieve a level 6 performance against these dangerous and aggressive chemicals but are still classed as low-level protection by the standard.
For applications where a glove is required to provide chemical or microbiological protection it must be of complex design, keeping in mind that the key to identifying a glove of complex design is not the flask pictogram but the complex CE mark with the four digits identifying the Notified Body.
In addition, the fact that the flask pictogram is missing from the glove’s labelling, does not necessarily mean that it does not possess good protective properties against a chemical you may be using. Do some further detective work, give the manufacturer a call and see what additional data is available. The manufacturer’s data will almost certainly include other chemicals not in the prescribed list of 12, which may be relevant to your area of use.
References
1. Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace available from eur-lex.europa.eu
2. Council Directive 89/656/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment available from eur-lex.europa.eu
3. EN 420:2003 + A1:2009, Protective gloves – General requirements and test methods
4. EN 374-1:2003 Gloves giving protection from chemicals and micro-organisms – Part 1: Terminology and performance requirements
EN 374-2:2003 Gloves giving protection from chemicals and micro-organisms – Part 2: Determination of resistance to penetration
EN 374-3:2003 Gloves giving protection from chemicals and micro-organisms – Part 3: Determination of resistance to permeation by chemicals
5. EN 388:2003 Protective gloves against mechanical risk
6. EN 407:2004 Protective gloves against thermal risk
