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Frequently asked questions for Sempermed

Frequently Asked Questions

The best information always comes first hand

Do you have any questions? We are here to answer them. Please have a look at our most frequently asked questions below. We have grouped them so you can find what you are looking for more easily. 

 

Glove materials

What are disposable gloves and why are they used?

A single-use glove, commonly made from natural or synthetic rubber, covers the whole hand and can be used to protect the wearer against harmful environmental influences. As the name implies, single-use gloves, also referred to as disposable gloves, are designed for single use only and should be disposed of immediately after use. For example, in healthcare, caregivers wear gloves to protect themselves and patients from infections.

Which are the advantages and disadvantages of the different glove materials?

Natural rubber latex gloves, often simply referred to as latex gloves, offer good resistance towards acids and alkalis.* However, they are permeable to many solvents. Due to their outstanding elongation, latex gloves are very comfortable to wear and traditionally provide optimal fit and feel. One main disadvantage is that natural latex proteins can cause or trigger natural rubber latex allergies.

Nitrile gloves are made of nitrile butadiene rubber (NBR), a synthetic material. They can be used as an alternative glove choice for people suffering from an allergy to natural rubber latex. A significant advantage is the improved resistance towards many chemicals* as well as oils.

Vinyl gloves are a cost-efficient alternative when mechanical stress and barrier protection are less of a factor. Their skin-friendly material is suitable for users suffering from latex or chemical allergies. A disadvantage is that the use of plasticizers as the key component in the production of vinyl gloves excludes their use in handling of lipids and fatty foods. Furthermore, the comfort of wearing vinyl gloves is less compared to nitrile or latex gloves, mainly a result of the limited elasticity of vinyl.

* CAUTION: Before gloves are used in contact with chemicals, please consult the chemical resistance lists, which can be found here. Failure to observe this information can result in personal injury and/or material damage. In case of doubt obtain expert advice before use.

Which types of disposable gloves exist?

Material 
The most commonly used raw materials in the production of disposable gloves are natural rubber latex (NR gloves), polyisoprene latex (IR gloves), nitrile butadiene rubber latex (NBR gloves) and polyvinyl chloride (PCV gloves). 

Size & shape
Disposable examination and protective gloves are usually available in various sizes ranging from XS to XL and can be equally worn on the left or on the right hand (ambidextrous shape). In contrast, surgical gloves are anatomically shaped (specifically for the left or right hand) and offered in a larger variety of sizes.

Texture 
Gloves are offered in several different textures, from smooth to fingertip or fully textured varieties depending on the application. Our surgical gloves come with a micro-rough surface. 

Inner treatment 
Disposable gloves can either be powdered or powder-free. Powdered gloves offer the advantage of easier donning even with moist hands. In general, powder-free natural rubber gloves are more skin tolerable as they contain fewer chemical residues and water-soluble proteins thanks to the manufacturing process. Potential irritations are also minimised due to the absence of powder. For powder-free gloves, special manufacturing processes such as synthetic inner coating or chlorination facilitate easier donning. 

Colour 
Disposable gloves come in various colours depending on colour preference or any required usage recommendation (e.g. blue colour for HACCP compliance for use in the food industry).

Sterility 
Non-sterile gloves are mainly used for hygienic purposes or for self-protection, whereas sterile gloves are used for sterile procedures in hospitals or laboratories, where a contamination of patients and/or handled materials must be avoided. 

Why are gloves made of vinyl (PVC) not suitable for handling fatty food?

In PVC glove production, softeners (plasticisers) are used as one of the main materials besides PVC in order to give the glove the necessary elasticity, softness, and flexibility. Plasticisers, including phthalates are not permanently bound to the PVC polymer, but rather form a leachable element, which is why they show a tendency to migrate into food. As plasticisers are highly soluble in fats and oils, the migration level of plasticisers in contact with fatty foodstuffs exceeds the limits allowed in EU directives. Therefore, vinyl gloves should be avoided in the handling of fatty foodstuffs. 

Skin-friendliness / Allergies

Are powder-free gloves completely free of particles?

Due to the distinct production processes, minimal quantities of powder residues may still be detected on powder-free gloves. In case the residual powder content accounts for less than 2.0 mg per glove (according to the test method described in the EN 455-3), the glove is by definition considered powder-free. 

How can one prevent a latex allergy from arising?

A latex allergy can be prevented by using gloves which are free from natural rubber latex, such as nitrile or PVC, chloroprene of synthetic polyisoprene gloves, or by using powder-free latex gloves with a reduced protein concentration. If natural rubber gloves are used be sure to use only powder free gloves featuring a low protein level.  

Often underestimated, but important and a basic point to prevent an allergy is consistent skin care. Hands should be dried properly after washing, not only before donning. The use of lotions prevents the skin from dehydrating and helps to keep the protective function of the glove.

 

Is there a limit to the protein content of latex gloves?

Powder-free gloves undergo an intensive leaching and washing process in order to ensure that the leachable protein level is as low as possible. However, for technical reasons it is not possible to remove latex proteins exhaustively – and as such the potential risk for sensitised users and patients. Consequently, as part of risk control measures for any glove made from natural rubber it must be clearly indicated on the primary packaging that the glove contains natural rubber latex, and an additional warning must be included that the product may lead to allergic reactions. According to EN 455-3, the lowest protein level that a manufacturer is allowed to claim is 50 µg/g. This is due to systematic uncertainties in the protein quantification.

What is the allergy potential of disposable gloves?

Water soluble proteins which can be extracted from natural latex gloves due to sweat can cause allergies and are one of the main reasons for allergic reactions towards disposable gloves. This kind of allergy to natural latex proteins is called an immediate type (Type I) allergy. Allergic reactions to chemicals used in the production process are called type IV (delayed) allergies. 

Quality & Regulatory

What are the regulatory requirements for disposable gloves?

The two relevant regulatory pillars for disposable gloves in Europe are the Medical Device Regulation EU 2017/745 ("MDR") and the Personal Protective Equipment (PPE) Regulation (EU) 2016/425 ("PPER"). The former refers to the protection of healthcare professionals and patients, the latter to the protection of PPE users.

Medical devices are categorized into different classes depending on the range of risk involved for the patient. Relevant classes for disposable gloves are:

  • Class I:  Non-sterile examination gloves
  • Class Is:  Sterile examination gloves
  • Class IIa:  Surgical gloves

The basic standard for single-use medical gloves is the EN 455 series, which defines the requirements for freedom from holes, physical properties, dimensions, test methods for biological evaluation, labelling requirements and especially also requirements concerning the expiry date.

Medical Device Regulation EU 2017/745, replacing Medical Device Directive (93/42/EEC), has come into force on 26 May 2021. All market participants must meet the new requirements.

PPEs are divided into three different categories depending on the risk against which they are intended to provide protection:

  • Category I: Protection against minimal risks (simple PPE)
  • Category II: Protection against moderate risks
  • Category III: Protection against lethal hazards or serious and irreversible damage to health (complex PPE)

For gloves labelled as PPE the basic standard is EN 21420 (which superseded EN 420). This norm defines the general requirements for protective gloves, e.g., the contents of the information for users, the safety of the glove material as well as the characteristics of the product (e.g., length, size, etc.). For chemical protection gloves, additionally EN ISO 374-series applies. This standard defines the specific requirements like penetration (movement of chemicals through material defects), chemical permeation (movement of chemicals through the glove film), degradation (deterioration of the glove material), and viral penetration.

What does AQL mean?

AQL is short for Acceptable Quality Limit and refers to a statistical standard for quality control, which calculates how many deficient units in a batch of manufactured products are permitted. This is determined by means of inspection of randomly drawn samples.

The lower the AQL standard, the higher the presumed quality level and personal protection.

What does PERMEATION mean?

Permeation describes the process in which a chemical diffuses and moves through intact glove material. It is usually indicated by the breakthrough time, meaning the time it takes a chemical to move completely through the material. Chemical permeation is normally tested according to EN 16523-1. For more stringent test requirements (e.g., when testing the permeation of chemotherapy drugs or other high-risk substances like fentanyl), the applicable test standard is ASTM D6978. Due to the increasing demand for chemical protective gloves, more attention is being paid to their resistance to various chemicals. We have imposed a requirement on our products to carry out chemical permeation tests on an ongoing basis in order to permanently control the quality of the gloves. The standard requires to specify these results in levels (defined in EN ISO 374-1). We pass on these levels to our customers by means of the permeation lists that are published annually. Read more about our specifications here.

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What does PENETRATION mean?

Penetration refers to the process in which a chemical moves on a non-molecular level through pinholes, tears or other glove imperfections.
Penetration is tested according to EN 374-2.

What does DEGRADATION mean?

Degradation describes a physical deterioration of the glove material caused by contact with a chemical, which may cause the material to shrink or swell, become stiffer or change its structure.
Degradation is tested according to EN 374-4.

What is tensile strength?

Even under extreme conditions, disposable examination gloves have to offer maximum safety. Therefore, robustness and tensile strength are of crucial importance. Tensile strength is defined as the force which has to be applied to a test sample until it rips. The European standard for medical gloves (EN 455) prescribes a force at break (median) of ≥ 6 Newton for examination gloves made from natural or synthetic rubber, ≥ 3.6 Newton for gloves made from thermo-plastic materials (e.g. PVC) and ≥ 9 Newton for surgical gloves.

Does the weight of a glove reflect on its quality?

The perceived high quality of a glove is often associated with higher weight, which is not necessarily true. Innovative formulations and well-optimised processes allow the production of high-quality, lower weight gloves. Such gloves can be produced with very low wall thickness (which allows a high tactile sense) while still surpassing normative safety requirements.

To reduce costs, some manufacturers use fillers which tend to be heavier than the polymers used in the glove. The moderate use of fillers is tolerable and can improve certain glove properties, whereas the excessive use of fillers can lead to a significant deterioration of glove performance characteristics. In addition, further factors affecting glove quality include the quality of raw materials used, specific formulations, manufacturing process and quality inspection system.

Is a thicker glove safer compared to a thinner one?

Protective and medical gloves must be thick enough to provide optimum protection for the job at hand. However, if a glove is too thick, the important sense of touch is lost. When it comes to surgical gloves, it is of utmost importance that they fit perfectly and that they have enough grip so that surgical instruments can be held properly. The real skill in latex dipping is achieving the optimal balance between wall thickness and sense of touch. 

Where can I find your certificates?

Sempermed's manufacturing plants and the entire manufacturing process are subject to most stringent quality tests and are regularly checked by TÜV and FDA. Therefore we have a number of certificates. If you require a product specific certificate please check our product section of the website. If you cannot find the required certificate please contact us and we will gladly send you the requested certificate. 
 

Special applications

How do I know that a disposable glove is suitable for food contact?

Gloves that are suitable for food contact can be identified by the glass and fork symbol, which is subject to specific EU regulations that govern articles intended to come into contact with food. 
The framework regulation EC 1935/2004 lays down the general requirements for all materials and articles (e.g., gloves) intended to come into contact with food. Platstic materials, such as vinyl, are subject to the EU regulation 10/2011, which determines specific requirements for products containing vinyl that may come into contact with food. Latex and nitrile products however are only regulated on a national level, e.g., in Germany upon the recommendation of materials for food contact of the Federal Institute for Risk Assessment (BfR) or in France by the law “Arrêté du 8 Août 2020.

How do I select disposable gloves for handling chemicals?

Glove selection should be based on the nature and potential hazard of the substances dealt with as well as the type of exposure. Thin disposable gloves are designed for incidental contact with chemicals, providing good barrier and basic chemical protection combined with good tactility and wearing comfort. In general, a higher thickness correlates with higher breakthrough times – but this is only valid for the same material. Nitrile gloves are usually preferred over disposable latex and vinyl gloves because of their enhanced chemical resistance.

IMPORTANT: If in doubt, please contact the glove manufacturer and ask for assistance in selecting the most appropriate glove.

We are always happy to help you decide which gloves fit your needs. Simply contact us via sempermed@semperitgroup.com.
For information about the chemical resistance of our gloves visit the chemical resistance page.

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Is it possible to disinfect disposable gloves?

Disposable gloves are not intended for disinfection and re-use (MDR, EN 455); therefore, this lies beyond the scope of risk assessment by the manufacturer. Such practice means a health risk for patients and healthcare workers (risk of infection, skin damage), since microfine glove lesions and the result of disinfection are both invisible. In legal terms, any person who changes the intended application of a disposable gloves assumes the risk in case of any infections (damages).

Which gloves can be used to handle cytotoxic drugs?

Chemotherapy drugs are highly toxic and are increasingly used as therapeutic agents for the treatment of cancer. Appropriate hand protection against chemotherapy drug exposure is vital, which is why gloves should be selected in accordance with the specific type of chemical used. Using a nitrile examination glove may be a viable alternative for the handling of cytotoxic drugs, whereas a surgical glove made of natural rubber latex or synthetic polyisoprene latex is recommended for the preparation of chemotherapy drugs. In any case, gloves using ASTM D-6978 to test for resistance against chemotherapy drugs should be chosen. Gloves should always be checked for damage before use. Moreover, double donning is generally recommended to increase protection.

Why do gloves for handling food often have a blue or blueish colour?

The fact that protective gloves oftentimes are blue may partly be ascribed to the principle of prevention defined in the HACCP (Hazard Analysis and Critical Control Points) concept. Protective gloves worn when handling foods are often coloured in a blue tone so that any part of the glove, if lost during such handling, is easily detectable as it is a colour not found in foods and is almost immediately identifiable. This minimizes the risk of contamination.

What does double donning mean?

Double donning or the practice of wearing two layers of gloves, provides enhanced safety in situations with increased risk of glove failure, for instance when dealing with particularly aggressive chemicals or high-risk patients.

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