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EN 455 Explained

Thursday, 22 February 2018

EN Standards may be confusing at the best of times, but when purchasing Work Gloves to be used for medical purposes, the importance of understanding EN standard 455 cannot be understated. This is the standard that ensures two things. Firstly, that the doctor, vet or first aider using the glove is safe from bodily fluids, chemicals and bacteria. Secondly, that the patients they are treating are safe from infection. 

Single Use Medical Gloves Undergo EN 455 Testing
Gloves are essential for maintaining hygiene in medical environments

For a glove to pass EN 455, it has to pass a meticulous set of tasks that are just as tough as any other standard. As it should be when people’s lives at stake. To save you from taking hours out of your day to trawl through endless rules and regulations, we’ve decided to break it down for you, into easy, digestible chunks.

What is EN 455?

EN 455 Medical Gloves for Single Use covers any glove that could be used for medical work. The glove must adhere to four separate parts before it is considered safe to be used for medical practice. The four parts are: 

  • Part 1: Requirements and testing of gloves for freedom from holes
  • Part 2: Requirements and tests for physical properties
  • Part 3: Requirements and tests for biological evaluation
  • Part 4: Requirements and testing for shelf life determination

Between them they ensure that the glove will be a barrier against micro-organisms, perform effectively without breaking, protect the user from toxic and hazardous materials, and lastly how long a glove will be fit for use. For further information on each part, keep on reading.

Part 1: Testing of Gloves for Freedom of Holes

One of the last things a doctor wants when treating a patient is an issue with the physical resistance of their glove. This puts the doctor at risk of dangerous bacteria and the patient at risk of infection. A watertight test is conducted where a glove is filled with one litre of water. The higher the AQL level at the end of the test, the more pinholes were found. 

An AQL of 1.5 is the standard needed to meet EN 455-1. The majority of gloves will gain 1.5, however some more specialist gloves will reach 1.0 or even 0.65. 

Part 2: Tests for Physical Properties 

Something a doctor may want even less than a leak during use, is a tear during use. It is common for cheaper latex gloves to rip apart while donning. Makers of medical gloves have the challenge of creating a thin glove than will grip, be comfortable, and will fit close to your hand without breaking. 

Understandably, there are different expectations of gloves that have different purposes. You cannot expect a glove made for a simple inspection to adhere to the same standards as a glove designed to be used during surgery. The test pushes a force on the glove to measure when it will break. Below is the force needed for a glove to withstand to comply. 

Type of Glove Force Needed to Break (Newtons)
Surgical Gloves 9.0 Newtons
Rubber Gloves (inc. Latex) 6.0 Newtons
Thermoplastic Gloves (Vinyl) 3.6 Newtons

Part 3: Tests for Biological Evaluation

It may come as a surprise, but gloves are manufactured with a wide variety of chemicals, plastics, powders and irritants that may cause you harm. EN 455-3 exists to ensure that you are protected from the glove. 

With four different areas of testing, part 3 attempts to prevent the user from developing irritable skin, suffering an allergic reaction or gaining more serious illnesses such as a fever. It is important to remember that there is always a risk of reacting to your glove, but EN 455 demands that the risk is as low as possible. The four tests are: 

  • Chemical Residues: A test is conducted to understand the levels of chemical residue left on the glove from manufacture.  
  • Latex: Tests are carried out to discover the latex protein levels on the glove. The higher the level of protein, the higher the chance of irritable skin.
  • Powder: Powder-free gloves boast about their lack of potential irritants, but must be checked to ensure they meet the correct specifications. A powder level that exceeds 2 mg/glove is considered enough for a powdered glove.
  • Endotoxin: Just for sterile gloves, the endotoxin must be checked. For a glove to pass as low endotoxin, the level must be below 20EU/pair of gloves (EU = Endotoxin Units).

Part 4: Determination of Shelf Life

Finally, a test is carried out to ensure the glove will not degrade while it is in transit, in a warehouse, or awaiting use. This is why Latex gloves come with a shelf life. The chemicals and proteins that have gone into a latex glove can decay over time. Part 4 specifies that medical gloves can only be stored for up to 5 years, which is the maximum shelf life for a glove.

Buying Your Single Use Medical Glove

So there you have it. All of the tests your medical work gloves will go through before they end up on your hands. Here at Work Gloves we have a wide range of EN 455 certified single use medical gloves that keep you and your patient safe. If you want to see our quality, safe and varied Single Use Medical Work Gloves that adhere to EN 455, don’t hesitate to click the link.