Examination gloves: personal protective equipment versus medical device?
In Europe, an examination glove (a glove for one time use) can be put on the market following two Directives.
Medical Device Directive
This glove has to meet the requirements of the Medical Device Directive 93/42/EEG (MDD).
Personal Protective Equipment Directive
This glove has to meet the requirements of the European Directive Personal Protective Equipment 89/686/EEG (PPE).
A medical examination glove is under the MDD classified as a class I medical device. When these gloves are put on the market a manufacturer has to indicate that the gloves meet the essential requirements of the MDD by way of self-assessment. As long as these requirements are met the gloves can be freely commercialized on the European market. The packaging of the gloves includes a CE marking without a recognition code.
Please note that it is possible that an examination glove meets at the same time the requirements of the MDD and the requirements of the PPE. Please note and check on the packaging how the glove is labeled (pictograms). In case a glove has to protect against chemicals the glove is classified as complex, a so-called category III glove. The CE-marking shall be accompanied by the recognition code of the notified body.
Sterile surgical gloves are categorized in as a Class IIa medical device and have to be assessed by a notified body.The packing of these gloves includes a CE marking with the recognition code of the notified body.
Which chemicals are used in MPXX™ treated examination gloves?
Chemicals such as thiurams, mercaptobenzothiazole, diphenylthiourea and diphenyl guanidineare are not used in the manufacturing process of MPXX™ treated examination gloves.
A certain amount of carbamates is used in the compounding process but due to the application of MPXX™ the test results on chemical residues show that carbamates are either not present or the concentration is below the detectable limit. Test reports are available upon request.
Powdered or powder free gloves: what is the difference?
Powder, mostly cornstarch, makes it easier to put on a glove (called “donning”). Furthermore, powder is used in the manufacturing process to avoid gloves sticking together. The demand for powdered gloves is declining since the powder is linked to spreading allergy and causing infections. Powdered gloves are less expensive to manufacture.
Most international norms specify the levels of powder or the acceptable residue.
Due to the fact that gloves without powder are sticky and/or tacky it is difficult to don. In order to overcome this problem manufacturing works with alternative production methods/ donning agents, mostly single sided or double sided chlorination or the use of a polymer coating.
Chlorination is a treatment that normally involves a proces whereby gloves are treated with a chlorine solution. After chlorination the gloves are rinsed with fresh water and subsequently dryed. The amount of chlorine used in this proces effects donning and tackiness. Also the amount of protein is reduced by chlorination although not to unquantifiable levels.
Gloves are double sided chlorinated when the gloves are also chlorinated on the work surface.
How chemical residue free is an accelerator free glove?
Chemical accelerators such as thiurams, mercaptobenzothiazoles and dithiocarbamates play an important role in the so-called vulcanization process, one of the critical steps in glove manufacturing. However, users should be aware that there are much more chemicals or residues of chemicals that could trigger skin problems or so-called (allergic) contact dermatitis.
Specifically, replacing one chemical by another chemical could seem relevant for now, but can later prove insufficient. Users should ask the question: “How chemical residue free is an accelerator free glove?”
The French study and research group on contact dermatitis GERDA published a review article of Marie-Bernadette Cleenewerck in Eur J Dermatol (EJD, vol. 20, no 4, July-August 2010) in which she concludes that in order to recommend appropriate substitution gloves, it is important to know their chemical composition exactly. Furthermore, the conclusion is made that due to changes in manufacturing processes and the composition of medical and surgical gloves, users should remain vigilant and follow the latest updates in the future.
Why MPXX™ treated gloves?
Gloves come in different types of material, such as natural rubber latex, vinyl and (soft) nitrile. Nitrile and vinyl are synthetic alternatives to natural rubber latex. Research evidenced that mainly vinyl is less strong compared to latex gloves and therefore pinholes can occur faster. Vinyl does not have the excellent fit as latex.
The so-called soft nitrile gloves, the thinner gloves compared to the conventional stiff, mostly blue, glove are less strong and do not protect as expected.
The choice of the material depends on different factors such as comfort, fit, use, permeation of chemicals and sensitivity to the material (see below under allergy). Be aware of what you purchase and use !
Why MPXX™ treated gloves? MPXX™ treated gloves have excellent durability, a better fit and more comfort for your hands due to the superior tensile strength. They are stronger and offer high barrier protection. Overall MPXX™ treated latex gloves protect better compared to any other glove, including vinyl and (soft) nitrile gloves.
Please note. Users who are allergic to latex proteins (Type I) should avoid contact with latex products.
Cases of (allergic) contact dermatitis are increasing due to the use of inferior synthetic products / materials.
Could nitrile gloves cause an allergic reactions?
Yes. All gloves, including synthetic gloves such as nitrile glove, are manufactured using chemicals. The residues of these chemicals can cause a so-called type IV allergy, also known as (allergic) contact dermatitis.
It is likely that for thinner gloves which contain higher amounts of fillers as comparable products, additional chemicals are added during the manufacturing process. This is done to compensate the lack of raw material and is applied for every type of material. These added chemicals increase the risk on contact allergy type IV.
More and more cases of allergic reactions to nitrile gloves are being reported.
Is latex allergy a common problem?
Approximately 1 to 3% of the world population is potentially sensitized to natural rubber latex, although not all sensitive persons develop the symptoms.
Some studies show that up to 17% of the medical staff is at risk.
It is important to know the difference between a Type I allergy and a Type IV allergy. A lot of users are complaining about the sensitivity of the skin around the area of use. This is mostly Type IV allergy, (allergic) contact dermatitis, and can mainly be attributed to the presence of chemical residues in the product. Chemicals are used in the production process of nitrile, neopreen and polyisoprene gloves.
How do I recognize MPXX™ treated products?
MPXX™ treated products can be recognized by the packaging. The packaging always carries the official MPXX™ logo or the MPXX treated logo in case of OEM.
How is the MPXX™ technology supported?
MPXX™ is a proven and robust technology which is supported by a variety of test methods. All MPXX™ treated products (as far as applicable) meet the relevant international standards, including EN 455, 1 – 4, EN 420, EN 374 and EN 388 and the ASTM standards. All tests are executed by independent international accredited laboratories.
Which allergic reactions are caused by gloves?
In principle two types of allergic reactions can occur. A Type I reaction on natural rubber latex proteins / allergens and a Type IV reaction (allergic contact dermatitis) on the chemical residues of the chemicals which are used in the production process of gloves in general (think of materials such as nitrile, polyisoprene and neopreen).
NRL products treated with MPXX™ have undetectable levels of allergens and chemical residues due to which the risk on allergy Type I and IV is reduced to a minimum.