Q&A Answers to most frequently asked questions
We reviewed all the questions we are asked during our daily work, summarized them, and prepared a compilation of answers available for your organization and your customers. Let’s raise the bar for safety together by helping partner organizations understand these crucial concepts!
Disposable Glove Questions
What is a disposable glove?
Disposable gloves are single-use hand films made from natural rubber, synthetic rubber, or plastics, and provide protection against certain threats in the surrounding environment.
They should be used one time, by one user, for one examination or treatment and get disposed immediately after use, according to the local legislation.
From what materials gloves are made of?
The categorisation involves three main groups:
- Natural Rubber Latex (NRL) products, that are made of natural rubber latex provided by trees, mostly planted in Southeast Asia.
- Synthetic Rubber Latex products, that are made of synthetic equivalents of natural rubber. The raw material is produced in chemical plants. A famous example is Nitrile Butadiene Rubber (NBR), which is used to produce Nitrile gloves.
- Plastic products, that are made of thermoplastic materials. Their raw materials come from chemical plants, like Polyvinyl Chloride (PVC), which is used for Vinyl gloves.
What are the types of gloves depending on usage / application?
There are endless fields of applications for gloves, but in general they are categorized as following:
The gloves protect both the user and the patient by viral penetration.
They are widely used by practitioners in hospitals but also in dentistry, nursing, child-care, mobile and home care.
This category is universally used by professionals working in the heavy industry.
The gloves are specially designed to protect from hazardous elements such as, toxic chemicals or electricity.
- Food Contact:
Products designed for the F@B market’s needs. In the food industry, is important to keep raw materials and the food, intact. The gloves protect the user and prevent the food by getting contaminated.
Gloves are suitable for other applications as well, household chores, catering, gardening, cleaning, and laboratory work are only a few. Certain gloves can cover more than one category, in some cases they cover all the above.
Are there any other factors used for categorisation?
Gloves are available in sizes ranging from XS to XL, depending on the product type.
The shape may differ according to application.
Gloves used for surgical operations have a different shape compared to the ones used for examinations by nurses and practitioners.
The gloves suitable for gardening might have other features than the basic household gloves.
Texturing appears on the palm and finger area of the gloves.
The optimization of texturing ensures that the users have a good grip on tools and surfaces, even under wet conditions.
There are three basic categories for texture: smooth, finger and fully textured gloves.
Smooth gloves do not have any texturing at all.
Finger textured gloves have the finger area textured only.
Fully textured gloves normally have a textured grip from the tip of the fingers up to the wrist.
Gloves are available in many assorted colours.
Colored gloves are widely preferred, not only because they add elegance to every appearance but for practical reasons too. For instance, in a milk production factory where the surroundings are dominated by white and yellow colors, a blue glove would be easily identified, in case it accidentally falls into the food.
Gloves can be sterile and non-sterile. Most single-use examination gloves are non-sterile, while all surgical gloves are sterile.
Is a thicker or heavier glove always better?
Not necessarily, while in general, a significantly thicker glove might provide more protection, this rule does not apply to all.
Improvements in the chemical formula and in the production’s process stability allow for thin products to achieve the same performance with the thick ones.
Nowadays, 2.5g and 3.0g nitrile glove versions are performing identical to the 3.5g and 4.0g versions that were used in the past.
What is the difference between sterile examination gloves and sterile surgical gloves?
Sterile examination gloves do not qualify for usage in surgical operations. Their intended use is technically the same as non-sterile examination gloves. However, a number of professionals would choose sterile examination gloves to avoid lab contamination.
Surgical gloves are sterilized to prevent microorganisms from entering the patient’s body during a surgical operation. Like all things in the surgeons' domain, gloves can only be used if properly sterilized. Unlike other tools, such as surgical knives, surgical gloves are delivered in an airtight packaging called "pouch"and are one-use only.
Are medical gloves regulated?
Yes, they are.
According to Medical Device Regulation 2017/745, class I products are classified for examination and class II for surgical use. Regulations apply to all European Union and the European Economic Area countries. Turkey, Switzerland, and the UK, follow the same regulatory system with some adjustments.
Standard EN 455, sets the production standards for examination and surgical gloves. It defines the look, the strength, the amount of powder they should carry and their shelf-life requirements.
The Standard comes in four parts, each focusing on another feature:
- Part 1: Freedom of holes
- Part 2: Physical appearance and requirements
- Part 3: Chemical and biological requirements
- Part 4: Shelf-life determination
Products that meet the above requirements carry a CE mark which is placed either on the gloves or on their packaging.
Are non-medical gloves regulated?
Yes, they are.
According to the Personal Protective Equipment Regulation 2016/425 they should follow the standards, EN 21420 and EN 374. Products that fulfil the requirements carry a CE mark which is placed either on the gloves or on their packaging.
Gloves intended to protect food material, go under the EC 1935/2004 and its subsequent regulations. Products that fulfil the requirements carry a glass/fork pictogram mark which is placed either on the gloves or on their packaging.
Is it possible to disinfect or otherwise re-use disposable gloves?
Re-using disposable gloves is against regulations, the gloves are designed for one-time usage only. Reusing the products could carry risks and, in most countries, it is considered a crime.
If an entity moves on, against the instructions of the manufacturer, to disinfect or, in any other way, sterilize used disposable gloves, it is taking full responsibility for the product’s safety and performance. The action carries legal responsibilities that apply to manufacturers, such as approved documentation and labelling.
Are medical or non-medical gloves safe for the Coronavirus SARS-COV-2 (COVID-19)?
Gloves are not specifically tested for Coronavirus (COVID-19). However, most medical and all personal protective gloves belonging to category III, which covers severe risks, are tested for one of the smallest viruses known to humankind, Phi X 174. This small virus is used in laboratory testing, for example for the standards ASTM F 1671 and EN 374-5.
This indicates that all excellent quality gloves offer sufficient protection against viral penetration when used properly.
What is the "latex allergy" and how does it affect what type of glove to choose?
"Latex allergy" is often referred to as type I allergy to proteins that are present in natural rubber latex and originate in the plant itself. Such proteins can be reduced during production, but they are hard to eliminate.
"Latex allergy" incidents have dropped down since powder-free gloves got a bigger share in the market. In addition to that, thanks to advanced technology, producers can now cut off proteins responsible for the specific reaction.
Nevertheless, people having allergic reactions to latex is recommended to use other materials, such as nitrile gloves.
In case of any reaction, remove the gloves immediately and ask for medical advice.
Are there other skin reactions to gloves beside latex allergies? What is a type 4 reaction?
In rare cases, skin irritations could be caused by products made from materials other than natural rubber. Often irritations manifest in mild symptoms like red skin, a rash or, in more severe cases, eczema and skin blisters. Adverse reactions are usually triggered by process chemicals that are common in the glove production, or by the cleaning processes used to leach them. Although measures have been taken to reduce such chemicals and improve leaching conditions. some people may still react to the traces of these substances, they might show symptoms of contact dermatitis or contact allergies that are called type IV or type 4 allergies.
Another reason for developing such symptoms can be the occlusion of ventilation in cases where the glove material is quite tight on the skin and sweat cannot evaporate. The lack of fresh air on the skin in combination with extensive sweating can cause skin irritations to people who are wearing gloves for many hours a day.
It is recommended to dry hands thoroughly before donning gloves, the donning will be easier, and the skin will be sufficiently ventilated. Also, it is recommended to avoid using wrong glove sizes that are too tight or too loose.
For this and other reasons, it is important to ensure that the products are made of the highest quality raw materials and are processed in the latest production technology. This will greatly reduce any risks, as the improved production processes ensure a lower protein content and with that, a lower risk for any of these effects. Consult GMT to learn more about our latex products.
Can glove materials, other than natural rubber latex, cause allergies?
Yes, other materials do incorporate substances, like processed chemicals, that can cause either allergies or irritations to people susceptible to them.
To prevent future accidents, GMT has labelled groups of substances that are known for causing skin problems to some users.
What is the AQL and where is it used?
AQL stands for Acceptable Quality Limit and is a number code of statistical standards, namely ISO 2859-1. It allows to clearly specify how many pieces of a batch can have a certain defect before the entire batch is considered out of the range of the specification. The standard lays out how many samples must be taken randomly and how many of them can have a defect before the entire lot is considered non-compliant.
In the glove business AQL levels are used for a variety of characteristics, but the most prominent one is the freedom of holes. Especially, for medical gloves an AQL of < 1.5 is required by testing with the water leak method. An AQL < 2.5 or AQL < 4.0 glove cannot be considered a medical glove within the EU, and this also applies, if the glove was tested with an unvalidated method other than water leak. In principle, the higher the number after the AQL, the more defects are allowed before the batch, or the lot is considered of insufficient quality. One might also find AQL levels in specifications for other characteristics, for example visual defects, certain impurities etc.
Protective Glove Questions
What is a protective glove?
A protective glove protects the user from the surrounding environment or certain aspects of it. Regulation 2016/425 includes three categories, although only the first and the third category are normally used to describe gloves.
- Category I is used for minimal risks, like prolonged contact with water. Although water can cause no severe harm, extended contact without wearing gloves might cause irritations.
- Category III is used for risks that might cause severe or non-reversable damage, even death.
- Category II, a category not used for gloves, they would be included in the two former categories.
What is permeation and what is degradation?
Permeation is a term used when a chemical, or any other substance, penetrates the glove. We can predict the gloves' resistance to several types of chemicals, by conducting tests with special devices.
Degradation is a term used when a substance changes the strength of a material used in gloves. Certain chemicals can make gloves stiffer or softer, while others are strong enough to turn a glove into a thin film vulnerable to the slightest pressure.
Laboratory tests do not reflect the actual duration of protection, since the materials are not tested under real conditions. We strongly advise you to check with us that the gloves you want to purchase are suitable for your workplace conditions. If you have any question about a material's resistance to certain chemicals, please do not hesitate to contact us. By providing us with the exact name and concentration of any substance, as well as a brief description of the task at hand, we will ensure you get the best protection according to your needs.
What is penetration and what is viral penetration?
Penetration is a term used when an element or chemical substance passes through small pinholes and cracks of the glove used. To test a glove's penetration, we follow standard procedures using water.
Viral Penetration is a term used when a small virus called Phi X 174 manages to pass through a glove’s pinholes or the material itself. There are two standards utilizing this virus, the US-American ASTM F 1671 and the European EN 374-5.
Laboratory tests do not reflect the actual duration of protection since the materials are not tested under real conditions. We strongly advise you to check with us that the gloves you want to purchase are suitable for your workplace conditions. If you have any question about a material's resistance to certain chemicals, please do not hesitate to contact us. By providing us with the exact name and concentration of any substance, as well as a brief description of the task at hand, we will ensure you get the best protection according to your needs.
Is the right quality of documentation important for Food Contact Material gloves?
Yes, it is important to not only have the test reports, but also have tested the right things and being able to understand why certain requirements are mandatory for one glove material while they are not for another. The results also impact the labelling and intended food contact applications. Although, the number of documents required for this category is not as high than for the others, the devil is hiding in the details and the quality of the documents is significantly harder to assess. No other regulations in the glove business are as opaque and difficult to look through, as they are written in a quite general way and the requirements can differ drastically depending on the glove raw material. GMT looks back on a decade of experience with food contact gloves, which allows us to help you work through the jungle of frameworks and test reports in this special field of glove applications.
Is the right quality of documentation important for Personal Protective Equipment Category III gloves?
Yes, for the protective glove category III, which are designed for any risks that could have severe consequences, the right set of documentation is key to ensure conformity and a flawless importing. These gloves can be found in laboratories, industrial productions, and other heavy-duty areas. They protect the users from threats like chemicals, microorganisms, mechanical force, or extreme temperatures and this must be proven by a proper set of documents. Products in this category have to undergo extensive testing and certification, supervised and issued by an EU Notified Body accredited for this kind of products. There are extensive requirements on how to establish proper documentation and records to verify the fitness of the products for these applications. On demand, GMT guides you through these processes with many years of experience and well-established contacts.
Is the right quality of documentation important for Personal Protective Equipment Category I (for minimal risks only) gloves?
This category is established in the regulation with the intention of very limited usage criteria and hence, the required documentation is limited, but at the same time hardly known by most market participants. The products are intended for minimal risk uses, that can occur in households, for example – anything from prolonged water contact or working with mild cleaning agents. Nevertheless, it requires a basic amount of documentation and some quite specific details that have to match with the labelling. GMT can guide your organization through the minimum requirements, so that any hiccups can be avoided.
Is the right quality of documentation important for medical device gloves?
Yes, the documentation for the medical examination gloves, categorized by its broad applications, is very important. Used from nursery to dentistry and mobile home care, these products are subject to a variety of requirements especially in terms of documentation. The list of required documents for medical devices is long and the criteria for their quality is strict. Both, the introduction of the Medical Device Regulation and the COVID Pandemic, have greatly increased the regulatory oversight. Every import of medical devices is checked on proper documentation and any deviations can cause massive delays. This shall enable the market to only have safe products of standardized high quality in the market. Organizations in the medical device business must adapt and ensure that their documentation is fit to show the conformity of the product. GMT is able to advise you on what is required and what pitfalls are common in this highly complex field.