FACTS ABOUT GLOVES

There are many myths and facts about disposable gloves. Years ago, there was a lot of talk about how, in particular, care staff developed allergies to examination gloves. The question was whether it was due to the latex material or the powder that was often in the gloves to make them easier to put on. Many became ‘latex-averse’ and therefore switched to vinyl gloves. However, the problem is that in most situations, vinyl gloves give a false sense of security. They do not meet the requirements for protective equipment.

THE MOST COMMON MATERIAL FOR MEDICAL GLOVES ARE:

When choosing an examination glove, it’s important to evaluate the different material properties to select the right glove for a particular procedure and individual.

On our glove boxes, there are clear pictograms indicating which procedures the gloves are approved for.

DID YOU KNOW ABOUT LATEX GLOVES?

Latex gloves are made from a natural product extracted from the sap of the rubber tree Hevea Brasiliensis.

Natural rubber latex is an attractive material to use for gloves because:

The problem is that natural rubber latex is a natural product that contains various proteins that can be allergenic. Therefore, there is a need for gloves made of other materials.

EU STANDARDS

All personal protective equipment must be approved in accordance with the EU’s regulation 2016/425, and beyond that, there are a series of EN standards that need to be met within the various areas. World Medico helps you comply with the legislation and take care of yourself. We can guide regarding EN standards for work gloves and respiratory protection.

There are EU standards for medical disposable gloves EN/DS:

455 1-4

Medical disposable gloves serve as protection for staff and patients against cross-contamination. The quality of medical disposable gloves is governed by a European standard (norm):

EN 455:1-4

The standard applies to all types of medical disposable gloves, which includes both sterile and non-sterile gloves across all types of materials. The standard is divided into 4 parts:

EN 455:1

It concerns the gloves’ liquid tightness and how the liquid tightness test is performed. The gloves must not be leaky during the liquid tightness test. The glove is filled with 1000 ml of water and the tightness is measured immediately and again after 2 and 3 minutes. The standard prescribes an AQL (Accepted Quality Level) of 1.5 or below when it comes to tightness – often described as pinholes.

EN 455:2

It concerns the gloves’ dimensions and strength. The gloves’ minimum length, as well as the measurements that indicate which size. Examination gloves: The minimum length is 240 mm without seams regardless of size. The minimum width varies with the size from extra small which should be ≤ 80 mm to extra large which should be ≥ 110 mm. Surgical gloves: The minimum length for size 5 is 250 mm and the width should be 67 +/- 4 mm. For the largest defined size of surgical glove, which is 9.5, the minimum length is 280 mm and the width is 121 +/- 6 mm. The standard describes how the strength test “tear strength” is performed, as well as the minimum values the gloves must meet throughout their lifespan. Tear strength is measured in Newtons (N) and the minimum values vary for the different glove materials. The requirements for tear strength also differ from surgical gloves to examination gloves.

EN 455:3

It concerns biocompatibility. This section defines what and how the gloves should be tested, as well as how glove packaging should be labeled. Targets for extractable latex proteins, endotoxins, and chemicals (accelerators) are described. The protein quantity is used as an approximate measure for the amount of allergenic protein. If protein content is specified, it is not allowed to state values below 50 µg/g as it is not possible to measure this. There is no requirement for sterile gloves to be endotoxin-free. However, there is a recommendation that sterile gloves should have a maximum endotoxin content of 20 EU/pair (EU: endotoxin units). Manufacturers must, upon request, provide information about added chemicals.

EN 455:4

It concerns biocompatibility. This defines what and how the gloves should be tested, and also how the glove packaging should be labeled. The objectives for extractable latex proteins, endotoxins, and chemicals (accelerators) are described. The protein amount is used as an approximate measure of the amount of allergenic protein. If the protein content is specified, it is not permitted to state values below 50 µg/g as this cannot be measured. There is no requirement that sterile gloves must be endotoxin-free. However, there is a recommendation that sterile gloves should have a maximum endotoxin content of 20 EU/pair (EU: endotoxin units). Manufacturers must, upon request, provide information on added chemicals. Describes requirements for and testing of shelf life with the aim of ensuring that the glove’s function can last the entire defined lifespan of the glove. NOTE regarding food and vinyl gloves: It is no longer allowed to use vinyl gloves with more than 0.1% phthalate content for direct handling of fatty foods such as meat, poultry, fish (Food Directive 2007/19/EC).

AQL – PINHOLES

Medical disposable gloves are tested according to fixed sampling plans for pinholes. The European standard DS/ISO 2859-1 defines, based on a predetermined quality level expressed by AQL (Accepted Quality Level), a sample size. The sample size depends on the size of the batch that has been produced. The lower the AQL, the fewer gloves with pinholes are accepted in a given sample size. This also means less risk for the user and patient. Medical disposable gloves must have an AQL value for tightness (pinholes) of a maximum of 1.5.

DID YOU KNOW ABOUT LATEX GLOVES?

Vinyl gloves are made of PVC, which is an oil-based synthetic material that has added softeners – phthalates. Previously, the vinyl glove was the preferred choice if there was a desire for a latex-free glove. In recent years, there has been a focus on the fact that vinyl gloves often do not provide adequate protection. PVC offers a lower level of protection due to its higher permeability and less tensile strength. Additionally, there has been increased attention for many years to the potential health-damaging effects of phthalates and the environmental damage of PVC is a topic of discussion.

Vinyl gloves are used as an alternative to natural rubber latex:

“Powder is sometimes used in medical gloves to make it easier to put the gloves on. The powder is usually cornstarch. In latex gloves, powder can bind latex proteins and thus help spread these allergens into the air, resulting in the risk of serious allergic reactions for those allergic to latex.

10 GOOD PIECES OF ADVICE FOR THOSE WHO USE EXAMINATION GLOVES:

Use gloves that fit in size and shape.
Avoid wet, damp hands inside the gloves.
Avoid powdered gloves (latex allergy/irritation).
Gloves should be changed between each patient and after each procedure with the same patient
Gloves should not be washed or disinfected and then reused for another procedure.
Gloves should be changed immediately if there is a hole in the glove.
For damp skin, cotton gloves can be used under the gloves.
Dispose of the glove after use.
Hand washing or disinfection should always be done after using gloves. The warm environment inside the glove is a breeding ground for microorganisms.

DID YOU KNOW THAT NITRILE GLOVES

Nitrile is synthetic rubber based on copolymers – butadiene. The base material can vary greatly from manufacturer to manufacturer, making the gloves slightly different. Likewise, production can be more or less environmentally sustainable. At World Medico, we have taken great care to deliver a high quality that is as sustainable as possible. Our nitrile gloves come in different thicknesses because there is a difference, for example, in what a mechanic needs versus a bioanalyst working at a fertility clinic.

The nitrile glove can be used for almost all tasks:

We have chosen to focus on nitrile gloves at an attractive price as they mostly meet the users’ needs. However, we can also supply latex gloves if desired.

WORTH KNOWING:

Remember that gloves can never replace good hand hygiene. A contaminated glove spreads infection just as if no glove was used. Always wash hands thoroughly when visibly dirty or after contact with potential viruses/bacteria, after using the toilet, etc. Use water and soap. If hands are dry and clean, hand disinfection can be used.

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