European standards for disposable gloves - EN 374, 455 and EN ISO 21420: 2019
European standards for disposable gloves
Disposable gloves are akey component of protective equipmentinvarious industries where hygiene and patient safety are of paramount importance. Wearing disposable gloves is particularly important in hospitals, medical practices, and the food industry. By wearing disposable gloves, you protect not only patients or customers but also yourself. Since infection control is a top priority, all disposable gloves on the market must undergo specific testing procedures to be sold as, for example, medical examination gloves. After passing these various tests, disposable gloves receive a label that is also required by law.
Below, you’ll find insights into thenecessary markings in your industry, the various testing procedures, and what each marking signifies.
What labels are there?
EN 455 - European Standard for the Medical Sector
To receivetheEuropean Standard 455 certification, disposable gloves must undergo various tests. Once the disposable gloves have successfully passed these tests, they may beusedinthe medical field. Disposable gloves without the EN 455 certification are not approved for medical use, as this standard ensures the protection of both patients and users against contamination.
.EN 455 can be divided into four different categories
- EN 455-1: Leak tightness
- EN 455-2: Physical properties
- EN 455-3: Biological evaluation
- EN 455-4: Durability
EN 455-1 Leak-tightness of disposable gloves
For infection control, it is very important that disposable gloves areimpermeable to liquids and other secretions. This protects not only the user of the disposable gloves but also the patient. The leak-tightness of disposable gloves is tested as follows: First, the gloves are hung up one after another and filled with water until the material is taut. Next, the gloves are inflated with air, submerged in water, and then observed tosee if air bubbles rise. These test runscheck for holes in the gloves. If anyare found, the defective gloves are immediately sorted out. The number of gloves sorted out is recorded and evaluated. The result of this evaluation is expressed as theAQL value. More information on the AQL value can be found later in this article.
Since the discarded disposable gloves may no longer be sold, the leak test is conductedon a random sample basis. The number of disposable gloves to be tested is specified for each safety level.
CE Cat. I Protective clothing for minimal risks
CE Cat. II Protective clothing for medium risks
CE Cat. III Protective clothing for high risks
EN455-2 Physical Properties
To verify the physical properties, tests are conducted to determine howtear-resistant and durablethe disposable gloves are. The European standard 455-2 also specifies therequired sizes and dimensionsof disposable gloves. Disposable gloves that do not comply with the exact specifications of EN 455-2 must not be used in the operating room.
The applicable specifications also distinguish betweensurgical glovesanddisposable glovesfor patient care or examinations. EN 455-2 also specifies the dimensions of an examination glove must have.
EN455-3 Biological Assessment
Examination gloves are categorized intonitrile gloves, vinyl gloves, latex gloves, and TPE gloves. It is common for medical personnelto have anallergicreactionto latex. Therefore,vinyl gloves or nitrile glovesare used as alternatives to latex gloves. To protect users, EN 455-3 requires that the packaging of disposable gloves indicate whether they contain latex.
Although powdered gloves provide a better grip, the use ofpowder-free disposable gloves isrecommended, as many nurses or doctors are often unaware that they are allergic to powder. Therefore, in addition to the latex content, the presence of powder in a glove must also be labeled.
According toEN 455-3, the powder content must not exceed a maximum of 2 mg of powder. Furthermore, disposable gloves certified to EN 455-3 mustnot be powdered with talc. Detailed information on the chemicals, endotoxins, powders, and leachable proteins used must be provided by the manufacturer in thedata sheetsavailable to everyone.
EN455-4 Shelf Life of Disposable Gloves
Disposable gloves cannot “go bad,” which is what one would likely associate with the term “shelf life.” However, the material from which the disposable glove is made can becomebrittle. The storage of the gloves also plays a major role in their shelf life. The manufacturer is therefore required to include storage instructions on the packaging.
There are two methods for testing the
of disposable gloves.
- Accelerated aging: The disposable gloves are heated in a special oven to simulate the aging process. They are then subjected to several tests. If they pass these tests, they are assigned a preliminary shelf life ofthree years.
- Real-time testing: As a rule, the maximum shelf life five years for disposable gloves. In order for a disposable glove to be labeled with a shelf life of up to five years, it mustundergo various tests multiple times over afive-year period. During those five years,the same tests as those specified in EN 455-1 and -2are applied.
EN 374 – European Standard for Permeation and Penetration
Since disposable gloves in certain industries, such aslaboratoriesorcleaning, must also beresistant to chemicals, the standardEN ISO 374:2016+A1:218, or EN 374 for short, applies. For this purpose, disposable gloves are subjected to various tests to assess theirresistance to chemicals and microorganisms. Disposable gloves are intended to protect the user from irreversible health damage; therefore, it is extremely important to check the packaging of disposable gloves or ensure they bear the appropriate markings before using them in a laboratory.
Currently, EN 374 is divided intofive different levels, with each level providing information on the tested scope of application.
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EN ISO 374-1:2016+A1:2018:Performance requirements for chemical risks
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EN 374-2:2019+A1:2018:Penetration resistance
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EN 16523-1:2015+A1:2018 (formerly EN 374-3:2003):Determination of the resistance of materials to permeation by chemicals and liquid chemicals under conditions of continuous contact
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EN 374-4:2019+A1:2018:Resistance to chemical degradation
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EN ISO 374-5:2016+A1:2018:Protection against bacteria, fungi, and viruses
EN ISO 374-1:2016+A1:2018: Performance requirements for chemical risks
The pictograms shown above must be marked on EN 374-certified disposable gloves. The standard applies solely to protection against chemicals.
Here distinguished betweenTypes A, B, and C.
Type A:Protection against chemical breakthrough for6test chemicals for at least 30 minutes
Type B: Protection against chemical breakthrough for3test chemicals for at least 30 minutes
Type C: Protection against chemical breakthrough for at leastone of thetest chemicals for at least 10 minutes
Thetest chemicalsused to evaluate the disposable gloves are always specified by the manufacturer on the glove packaging. Theidentification letters are always located below the pictogramunder the respective type.
In the table, you will find the old and new test chemicals with their respective identification letters.
EN 274-2:2019+A1:2018: Penetration resistance
To determine penetration resistance, anair leak testand awater leak testareperformed. The disposable gloves are filled with either water or air until the material is taut. For disposable gloves filled with water, a check is performed to see if water leaks out. The disposable glove filled with air is held in water, and then observed to see if air bubbles appear. If air bubbles appear, this indicates that the disposable glove is not airtight.
EN 16523-1:2015+A1:2018 (formerly EN 374-3:2003): Resistance of materials to chemical permeation
Permeation describes thepenetration of liquid or gaseous chemicalsthrough a barrier. The breakthrough time indicates how long it takes for a chemical to pass through the protective layer of a disposable glove and reach the user’s skin. Disposable gloves can be assigned different protection classes. The ruleis:The higher the protection class, the better the protection.
EN 374-4:2019+A1:2018: Resistance to chemical degradation
The material of which disposable gloves are made can change when exposed to chemicals. This change in material refers, for example, toa decrease in elasticityortear resistance. The fourth part of Standard 374 is therefore intended to provide information onwhether and for how long a disposable glove that has come into contact with any chemical may still be used. This standard is important for you if you work with chemicals on a daily basis, as it is then important to know when you need to change your gloves.
The testing procedure for EN 374-4:2019+A1:2018 certification proceeds as follows:
The disposable glove is exposed toone of the 18test chemicals (listed above) forone hour. It is then tested to determine whether and how the glove’spuncture resistancehas changed.
EN ISO 374-5:2016+A1:2018: Protection against bacteria, fungi, and viruses
EN ISO 374-5:2016+A1:2018 has only been in effect since 2016; prior to that, protection against bacteria, fungi, and viruses was covered in EN 374-1.
The test procedures in the fifth part of EN 375 are similar to those in EN 374-2. Anair leakage testand awater leakage testare also performed. In addition, however, there is a test procedure in which the disposable gloveis exposed toacontamination fluid. The contamination fluidcontains asimulated virus that can cause disease in humans.
If the glove passes the test successfully, it can be labeled with EN ISO 374-5:2016+A1:2018 and is proven to protect against bacteria, fungi, and viruses.
EN420 becomes EN ISO 21420:2019
EN ISO 21420:2019 is applied in conjunction with other European standards and ensures the accuracy of the data provided by the manufacturer.
The standard specifies that disposable gloves must protect the user when worn as directed by the manufacturer. Furthermore, the gloves must not cause any harm to the user’s health or trigger allergic reactions when used in accordance with the manufacturer’s instructions. A detailed list of all materials used in the manufacture of the gloves must be provided upon the consumer’s request.
