EN 455 Gloves Standards and Certifications
Wearing gloves is a common sight in many industries.
Nevertheless, whenever gloves are mentioned, most of us cannot help but have that picture of doctors, nurses, or hospitals.
Just hypothetically speaking, medical gloves have been around since the beginning.
And ever since, their technologies, certifications, testing, and standards have been growing and developing relentlessly.
Moreover, the pandemic has brought more gloves to the scene than at any other time in modern history.
Everyone is looking to understand more about them, how they’re tested, and what the best gloves are.
Elaborating on this, medical gloves are no exception.
If you work in the medical field or a related occupation, your disposable gloves must be EN455 certified.
It’s one of the most vital standards for medical gloves.
Even experts sometimes get confused about these standards, especially EN 455.
In this article, we will go over the EN455 Standard and its testing in detail, as follows:
- Medical gloves and their types
- What is EN455?
- EN 455-2:2015
- EN 455-4:2009
- Notes to the manufacturers on EN455 test reports
Medical gloves and their types
Medical gloves are a type of Personal Protective Equipment (PPE) worn by various medical and healthcare workers, including doctors, nurses, pharmacists, dentists, home caregivers, veterinarians, and lab workers.
They are part of the infection control strategy to reduce infections and cross-contamination, and they are used for the following reasons:
- They create a barrier against blood, bodily fluids, and secretions that could be contaminated with pathogens such as bacteria, viruses, and fungi, preventing infections and diseases.
- Protect against possible chemical and physical work injuries.
- Protect the patient from any hospital-acquired infection.
- Prevent cross-contamination
For these reasons, medical gloves should be used during all patient care activities with possible contact with blood, body fluids, mucous membranes, or broken skin.
Additionally, they should be worn in the potential or confirmed highly infectious diseases, epidemics, or emergencies.
What’s more, they should be worn when performing tasks that aren’t directly related to patients, such as cleaning patients’ rooms or belongings that could be contaminated, handling or cleaning medical tools, taking medical waste, or cleaning up spills of blood, body fluids, or vomit.
What are their types?
Medical gloves are disposable (single-use) gloves that can be:
- Examination gloves: sterile or non-sterile.
- Surgical gloves: must be sterile with specific different thicknesses
- , elasticity, and strength requirements.
- Chemotherapy gloves: for handling and transporting drugs used in treating cancers.
The FDA regulates medical gloves as Class I medical devices (1) that require a 510(k) premarket notification (PMN).
This clearance means that the manufacturers don’t need to provide information on the safety or effectiveness of their gloves based on clinical trials.
However, the FDA evaluates the quality and safety compared to other devices.
Notwithstanding, this doesn’t mean that the gloves aren’t tested; medical gloves must meet a few standards before they are presented to the market.
In addition to being able to protect the wearer against bloodborne pathogens, medical gloves must be tested according to the EN455 Standard.
Let’s find out more.
What Is EN 455?
Medical gloves are discussed in the European Regulation (E.U.) 2017/745 on medical devices (MDR), and accordingly, they should comply with some standards such as:
- EN-ISO 21420: General requirements and testing for protective gloves
- EN-374: Protection against harmful chemicals and microorganisms
- EN-388: Standard for cut protection
- ASTM-F1671-07: Resistance to Bloodborne Pathogens
- EN 455: Standard for Medical Gloves for Single-Use
EN455 is somehow equivalent to the following (with a few differences):
- ASTM-D3578:2005: American standard specification for rubber examination gloves
- ISO-11193-1:2008: Canadian Standard for single-use medical examination gloves
Understanding standards is crucial because it helps you decide which gloves to choose for the task.
Because when you choose the correct gloves, you select the proper protection for your and your patient’s health.
EN455 is helpful for:
- Disposable glove manufacturers
- Hospitals and medical facilities
- Medical glove test centers
- Regulatory bodies
- Quality control personnel.
It’s the essential Standard for medical gloves; it includes a series of tests to ensure your gloves can stand up against microorganisms without tearing or breaking down.
Therefore, ensure it’s safe and effective to use against the expected health hazards you may face.
Disposable gloves must pass the tests to be qualified as single-use medical gloves.
These tests are mainly divided into four parts, as follows:
- EN455:1- Requirements and testing of gloves for freedom from holes
- EN455:2- Requirements and tests for physical properties
- EN455:3- Requirements and tests for biological evaluation
- EN455:4- Requirements and testing for shelf-life determination
Finally, in 2023, a proposed Part 5 for extractable chemical residues is still under development (2).
Now, let’s see each one of these four parts in detail.
EN455-1:2020: Requirements and testing of gloves for freedom from holes
The one thing we all agree upon is that medical gloves are the barrier that protects us against microbes and dangers.
What if the barricade has a hole in it?
Microbes can pass through it and cause the illness you are attempting to avoid in the first place.
This puts not only you but also your patient at risk of infection.
Therefore, there must be a way to test the gloves to ensure they are free of holes that might snap or tear, letting the invaders in a while working.
That is when the first part of the EN455 Standard comes in.
EN455-1:2000 replaced EN455-1:1994, and finally, some technical changes were added to it to make it EN455-1:2020.
EN455-1:2020 includes a watertight test to determine how strong the gloves are when filled with water.
How does the test work?
This test is based on a penetration-resistant test similar to the one in EN374:2.
They fit the gloves over the end of a filling tube and close the cuffs well enough to get a watertight seal without damaging the gloves.
Then the gloves are filled with 1000 ml-/+50 of water at a temperature of 15–35 °C and immediately inspected visually for leakage.
The inspection is repeated after 2–3 minutes.
To prove that the gloves are effective against microorganisms, they must pass this test by holding the water with no leakage or pinholes.
This is done with a random sample from a batch of gloves to check their acceptable quality level (AQL).
What is AQL?
This is an international standard sampling process to evaluate the quality of gloves.
Since gloves are produced in huge quantities, you cannot test every glove in a batch.
Therefore, they select a random sample using standardized AQL found in ISO 2859-1 and ANSI/ASQ Z1.4.
To illustrate, they predetermine the highest number of defects (holes) that can be accepted in a random batch sample.
For example, in a sample of 100 gloves, an AQL of 2 means that only two gloves can fail this test.
If more than two gloves fail the test, this batch cannot be certified.
The lower the AQL, the higher the quality, and the fewer chances of defects in the batch.
For mechanical work and domestic cleaning, gloves with an AQL rating of 4.0 or higher are enough.
However, for a glove to have the EN455-1 certification and to be marketed as a medical glove, it must have an AQL of 1.5 or better.
The level for freedom from holes is an AQL of 0.65 for surgical gloves and 1.5 for examination gloves.
The AQL of medical gloves in ASTM D 3578 and ISO 11193-1 is 2.5, which makes EN 455 stricter and more precise.
The U.S. uses the ASTM D5151 Test Method to detect Holes in Medical Gloves.
If the glove passes the watertight test with no leaks or pinholes, it passes EN 455 Part 1, and you can be sure it’s free of holes and of good quality.
Examination gloves have an AQL of 1.5, while surgical gloves have one of 0.65.
Now let’s move on to Part 2 of the EN455 Standard.
EN455-2:2015: Requirements and tests for physical properties
Have you ever noticed that small or large gloves look the same no matter what brand you buy?
Do you wonder how they are so strong despite their thin appearance?
The answer to this is EN 455-2.
EN 455-2:2015 is the second part of EN 455; it replaced the earlier versions of EN 455-2:2009+A2:2013.
This part ensures that the size of the gloves remains consistent, regardless of brand.
Furthermore, it ensures your gloves are strong enough to be used for their intended purpose, so you can wear them safely and confidently without worrying they might tear if they come into contact with a rough surface or a tool.
The physical property requirements and testing for EN455:2 gloves:
They are divided into three sections based on the type of glove (surgical or examination) and material (nitrile, vinyl, polyethylene).
- Size (glove dimensions)
- Physical strength
Size (glove dimensions)
This part of the test ensures that gloves follow uniform sizing specifications, making selecting the correct size more manageable.
This part of the standard measures the glove’s length and width for 13 samples from each lot.
What is the lot?
A lot is the collection of gloves of the same design, color, shape, size, and formulation, manufactured at essentially the same time, using the same process, raw materials of the exact specifications, standard equipment, and packed in the same type of individual container.
Although the EN455-2 Standard doesn’t specify the size of a lot, the recommended maximum individual lot size for production is 500,000.
And finally, you can find a table describing the minimum requirement for the length and width of surgical and examination gloves.
For examination gloves, the sizes are from X.S. to XL with a minimum median length of 240 mm, whereas for surgical gloves, the dimensions are given as numbers from (5-5.5) to (9.5). Each with different widths and lengths.
Physical strength before and after challenge testing
This part of EN455:2 involves testing the level of force needed to break the material of the gloves down by adding pressure to it to see at what point they will die.
They take a longitudinal test piece from the palm, back of the hand, or cuff area of 13 gloves from a single lot, avoiding textured regions.
After that, they are stretched by a particular machine called an extensometer for a minimum of 16 hours.
Then they record the force required to break the gloves in N for each of the 13 samples and take the median value.
Finally, the gloves must also undergo a challenging heat aging test, in which the samples are tested for seven days at a temperature of (70 ± 2) °C in an oven, as specified in ISO 188:2007.
The requirement and results are different for each type of material as well as for surgical and examination gloves, as shown in the table below:
|Glove Type||Force Needed to Break (Newtons)|
|Surgical Gloves||9 N|
|Rubber Gloves (inc. Latex)||6 N|
|Thermoplastic Gloves (Vinyl)||3.6 N|
As we can see, surgical gloves require a higher score on the test.
In The U.S., they use ASTM D3767, “Practice for Rubber: Measurement of Dimensions.”
EN455-2 determines the gloves’ width, length, and uniform sizing.
In addition to testing how strong the glove is by putting it under stretching forces and challenging testing to determine how much power is needed to break it.
Now let’s see the third part.
EN455-3:2015: Tests for Biological Evaluation
Do you ever wonder why some gloves cause skin rashes and irritation while others don’t? Why can some be used for sterile applications while others can’t?
The answer to all these questions lies in the third part of the EN455 Standard.
Making disposable gloves contains chemicals, lubricants, sterilization residues, and pyrogens.
Even the most environment-friendly gloves will contain some chemicals and microplastics.
In 2015, the EN455-3:2006 was modified to the EN-455-3:2015 to help protect your skin from chemical rashes, allergies, and irritations and keep the irritants as low as possible.
This Standard ensures that your gloves will not make you sick or cause an allergic reaction.
To explain, it has four different tests for chemical residues, endotoxins, powders, and latex proteins.
Chemicals such as accelerators, antioxidants, lubricants, biocides, coatings, and sterilizing agents are essential to the glove’s manufacturing process. However, they could cause allergic reactions and dermatitis.
Therefore, gloves are tested using ISO 10993 to measure the levels of chemical residue left on the gloves after manufacturing.
According to EN455:3, “Gloves shall not be dressed with talcum powder (magnesium silicate).”
Additionally, the gloves’ manufacturers should have a list of chemical ingredients added during manufacturing or known to be found in the product and can cause adverse health effects.
Endotoxins “For sterile gloves”:
Endotoxins are a type of pyrogen that comes from the outer membrane of Gram-negative bacteria when they die or multiply.
Pyrogen is a medical term that refers to any substance that raises a patient’s temperature (causes fever).
Those pyrogens can be found in the raw materials or water used to manufacture the gloves.
What’s more, they can be present during the manual handling of the gloves.
When sterilized, gloves become free of microorganisms; however, they may not be free of endotoxins.
Endotoxins in sterile gloves should be less than in ordinary examination gloves.
Sterile gloves are used for:
- Any surgical procedures
- Vaginal delivery
- Invasive radiological procedures
- Performing vascular access and procedures (central lines)
- Preparing total parental nutrition
- Preparing chemotherapeutic agents.
These procedures are critical; few endotoxins or pyrogens can quickly enter the patients’ bodies and cause illnesses.
Therefore, the gloves must be sterile to ensure the safety of patients and prevent possible infections.
To be labeled “non-pyrogenic” or “low-endotoxin,” sterile gloves should be tested according to EN455:3.
In this test, they extract the outer surface of the gloves with endotoxin-free water (Limulus Amoebocyte Lysate, “LAL”) for not less than 40 min at a temperature between 37 °C and 40 °C.
The particles are removed from the extract, and the remaining liquid component is immediately tested for endotoxin.
The endotoxin level for sterile gloves must not exceed the limit of 20 endotoxin units (E.U.) per pair of gloves.
Cornstarch powder is commonly used to line gloves to make them easier to put on and take off.
In addition, they absorb sweat, allowing comfort and improving grip.
However, in 2016, powdered gloves were banned by the FDA for surgeon gloves and patient examination gloves.
They usually slow the healing process for patients, and the powder can be transferred from the gloves to the patients, causing more infections, illnesses, or surgical complications.
Furthermore, many powdered gloves have been linked to allergic and contact dermatitis reactions.
So, they pose a risk for both the patient and healthcare providers.
In EN455:3, medical gloves should be tested for powder residue according to EN ISO 21171:2006 to determine powder content and ensure their safety.
According to EN455, powder-free medical gloves have a powder level of <2mg per glove.
If any glove exceeds this level, it’s considered a powdered glove and is banned from usage in medical gloves.
This also goes per the ASTM D6124 test methods for residual powder and debris per glove. (3)
Latex (Measurement of leachable proteins)
Latex gloves have been the gold standard in the medical industry for decades.
It’s the most comfortable gloves; many surgeons adore them for their exceptional tactile sensitivity.
However, latex allergies are one significant downside to wearing latex gloves.
Latex gloves are made of the sap of natural rubber trees; therefore, they contain natural rubber proteins.
It was discovered that those N.R. proteins could cause allergic reactions in susceptible individuals, ranging from red rashes to itching and coughing to life-threatening anaphylactic shock.
In addition to frequent and long-term exposure to latex, the higher the level of latex proteins in the gloves, the higher the chances of irritating the skin and causing allergic reactions.
According to The Occupational Safety and Health Administration (OSHA), Healthcare workers are more likely than the general population to develop latex allergies, with 8-12% latex-sensitive.
Therefore, the levels of natural protein latex should be tested.
According to EN455:3, gloves are tested using the “Modified Lowery Assay.”
To illustrate, this test detects the levels of water-soluble proteins in the medical gloves made of NRL.
Nevertheless, in the Standard, other test methods are present.
Medical gloves that contain NRL must be labeled according to EN 1041:2008+A1:2013, and the label must include the following:
- A symbol indicates NRL’s presence (as defined in EN ISO 15223-1:2012).
- Warning statement: the product contains NRL, which may cause allergic reactions, including anaphylactic responses.
- Whether they are powder or powder-free latex glove
For sterile latex gloves, they must be labeled with the following statement:
“CAUTION: Surface powder shall be removed aseptically before undertaking operative procedures to minimize the risk of adverse tissue reactions.”
Finally, it shouldn’t contain any term that implies relative safety, for example, “low allergens, low protein, or hypoallergenic.”
With all of this in mind, you must be wondering:
Can you rely on this Standard to guarantee that your gloves are latex-free?
It’s complicated, but at the end of this Standard, the authors state that “measuring the total extractable patient isn’t the ideal method to control the NRL allergen content of medical gloves.”
Even though chlorination, leaching, or washing significantly reduces powdered residue and latex proteins, the FDA recommends that glove manufacturers stop making latex-free claims on their products.
Because there are no reliable tests that can show no NRL proteins in gloves. (4)
Hence, if we can’t be sure, then using the term “Latex-free” is scientifically imprecise and can be misleading.
Instead, they recommend using the expression “not made with NRL.”
EN 455-3 may appear complicated, but it is essential to ensure that the glove is correctly evaluated for biological agents before it is sold and, more importantly, safe to use by healthcare professionals.
It includes testing for levels of chemical residues, endotoxins, natural rubber latex proteins, and powder content in medical gloves.
Now let’s move on to the final part of the EN455 Standard.
EN 455-4:2009 Requirements and Testing for Determination of Shelf Life
No one wants to use an old glove, right?
That’s why the expiration and manufacturing dates are listed; they let you know whether or not these gloves are fresh and provide protection.
In the fourth and final part of EN 455, two tests are carried out under EN ISO 14971 to ensure that the gloves you buy will not degrade and become corrupt when stored for a while.
The first test is called “accelerated shelf-life determination,” where the gloves undergo a series of challenging tests and, based on their results, the theoretical shelf life is calculated.
After passing this test, the gloves can claim a maximum shelf life of three years.
Therefore, a “real-time test” must be performed.
To illustrate, they compare the gloves under test to samples already aged in real-time to determine how long these gloves will perform well.
That’s why this test can take years to be finished.
EN455-4 Specify that the medical gloves’ maximum shelf life is five years from their manufacturing date.
Because after this, the quality and effectiveness of these gloves are compromised.
Accordingly, your and your patient’s safety would be affected if you used them.
This Standard applies to any new or modified gloves before release.
Furthermore, gloves must be labeled with the shelf life and the user’s storage instructions, such as a pictogram to store dry and protect from heat.
At the end of the shelf life, the labeling must remain readable, according to EN 1041.
The EN ISO 11607 shelf life requirements must be applied for sterile gloves.
Remember, gloves can only last for a certain amount of time when stored correctly.
And after their expiration date, you can’t expect them to provide the protection you need.
Now that we’ve seen all the parts of EN 455 for gloves let’s see a few notes to manufacturers that can help them get their gloves certified.
Notes to the manufacturers on EN455 test reports
Now that we’ve seen a lot of testing, you, as manufacturers, could be overwhelmed and confused by which information you should provide to get the EN-455 certification for your medical gloves.
The EN455 wouldn’t leave you wondering at this point.
To illustrate, the data of each test should be included in a test report that includes the following:
- Date and description of the test method
- Test results (batch size, sample size, number of non-conforming gloves)
- Reference to an EN 455 or appropriate standard
- Type of glove sample details; complete identification of the material used
- manufacturing batch code
- Name and address of the manufacturer or distributor and the test laboratory
In addition to the following tests for shelf-life determination:
- Times, temperatures, and aging conditions
- confirmed the shelf-life claim.
To Sum it up,
Single-use medical gloves must meet the following requirements in addition to ISO EN420, EN374, and EN388 standards:
- AQL of ≤1.5 for examination gloves and 0.65 for surgical gloves (EN 455-1)
- Tearing strength of at least 9N during production in surgical gloves, 6N in latex gloves, and 3.6 in thermoplastic gloves (EN 455-2)
- Biocompatibility in terms of chemicals, endotoxins, and freedom from powder and leachable proteins (EN 455-3)
- Shelf life of at least three years (EN 455-4)
Now that we have reached the end of our article, we hope you have everything you need to know about the EN455 Standard.
Don’t hesitate to send us if you still have further questions.