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Frequently Asked Questions

Do you have any questions? We are here to answer them. Please have a look at our most frequently asked questions below. Below are answers to some of the most common questions from distributors, healthcare providers, and end users.

General FAQs

What types of gloves does HARPS Global offer?

HARPS Global offers a wide range of single-use, disposable gloves, including:

· Examination gloves, made from
Nitrile (NBR),
Natural rubber latex (NRL) and
Vinyl (PVC)
· Chemical protective gloves, made from
Nitrile (NBR) and
Natural rubber latex (NRL)
· Surgical gloves, made from
Natural rubber latex (NRL) and
Synthetic Polyisoprene (PI)
· Care gloves for low-risk applications made from
Natural rubber latex (NRL) and
Vinyl (PVC)
· Gloves for food contact applications, made from
Nitrile (NBR) and
Natural rubber latex (NRL)
· Specialty gloves like radiation protection gloves
· And a broad range of industrial protective gloves

Our products are premium medical, protective and food contact glove solutions designed for reliability, comfort, and consistent performance across applications and industries.

What industries do your gloves serve?

HARPS Global supplies gloves to a wide range of industries, including but not limited to:

Hospitals and surgical centers
Physician and dental offices
Long-term care facilities
Laboratories and Pharmaceutical
EMS and First Responders
Automotive
Pest Control
Veterinary
Food service and food processing
Janitorial and sanitation
Manufacturing and industrial environments
Beauty and Tattoo

If you are unsure which glove is best for your application, please reach out to our team for guidance.

How can I become a distributor?

If you are interested in becoming a HARPS Global distributor, then please visit our Distributor Portal page to learn more. We will review your inquiry and provide details regarding qualification requirements, product availability, and onboarding steps.

Who should I contact for compliance or regulatory questions?

For regulatory documentation or legislative inquiries, please contact our compliance team through the contact page. We are committed to transparency and providing the documentation required for audits, credentialing, and purchasing approvals.

Are HARPS Global medical gloves EU MDR / U.S. FDA compliant?

Yes. Our medical examination and surgical gloves marketed in the United States comply with applicable U.S. FDA regulatory requirements, likewise our CE-marked medical gloves comply with the applicable requirements of the EU Medical Device Regulation (EU MDR 2017/745).

These products are manufactured in facilities operating under ISO 13485-certified quality management systems and are tested in accordance with applicable EN, ASTM and ISO standards.

How can distributors access product documentation?

Registered distributors can access technical documentation through our secure distributor portal. Available documents are depending on the product(s) and market(s), and may include:

Product specifications
Technical data sheets
Certificates of conformity
Testing reports
Product formulation

If you need assistance accessing documentation, please contact our support team.

Where are HARPS Global gloves manufactured?

Our gloves are manufactured in certified facilities in Europe and Asia that meet international quality and regulatory standards. We maintain strict oversight of production processes, testing, and supply chain integrity.

How do I request pricing or a quote?

To request pricing, please complete our contact form or reach out directly to our sales team. Be sure to include product type, estimated volume, and shipping location to help us provide accurate pricing information.

Types of Gloves

What are single-use gloves and why are they used?

Single-use gloves are hand coverings, commonly made from natural or synthetic rubber or other polymeric materials, intended for limited use and disposal after use. They are used to provide a barrier between the wearer’s hands and the surrounding environment.

In healthcare, laboratory, industrial or food handling applications, single-use gloves are intended to help reduce the risk of cross-contamination between users, patients, and surfaces or foodstuff. They are designed for single use only and should be changed and disposed of appropriately after use.

Single-use gloves should never be disinfected (prior or during use), as organic solvents may lead to swelling of the glove film and compromise the physical properties.

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

Natural rubber (NR)
Natural rubber latex gloves offer good elasticity, fit, and tactile sensitivity. They generally provide resistance against aqueous solutions, including diluted acids and bases.

However, they may not be suitable for all chemical applications, as permeation can occur with certain substances, including most common, organic solvents. In addition, latex proteins may be associated with the potential for sensitization or allergic reactions in susceptible individuals.

Synthetic polyisoprene (PI or IR)
Synthetic polyisoprene is a synthetic elastomer designed to replicate the physical properties of natural rubber latex, including high elasticity, excellent fit, and good tear resistance.

Unlike natural rubber latex, synthetic polyisoprene is produced without natural latex proteins and therefore does not contain latex allergens associated with Type I (immediate) allergic reactions.

It is primarily used in surgical gloves, particularly in settings where users require latex-like performance while avoiding exposure to natural rubber latex proteins. It is also increasingly used in healthcare environments as part of latex-sensitive risk management strategies.

Nitrile (NBR)
Nitrile gloves are made from synthetic nitrile butadiene rubber and are commonly used as an alternative for users with sensitivity to natural rubber latex proteins.

They typically offer improved resistance to a broad range of chemicals, oils, and greases compared to natural rubber latex. Chemical resistance depends on the specific substance, concentration, and exposure time and should always be verified prior to use.

Vinyl (PVC)
Vinyl gloves are made from polyvinyl chloride (PVC) and formulated without typical Type IV allergens (e.g. vulcanization accelerators). They are typically used for applications with lower requirements for mechanical stress and chemical resistance.

Inherently, PVC gloves require plasticisers to provide flexibility and softness. These plasticisers are not chemically bound to the polymer matrix and may therefore be subject to migration under certain conditions. Depending on formulation, this can include phthalate or non-phthalate plasticisers.

*HARPS’ PVC gloves are manufactured without phthalates.*

Vinyl gloves generally provide lower elasticity and mechanical strength compared to latex or nitrile gloves and are therefore less suitable for demanding applications involving high stress or extended 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 (PVC 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?

PVC gloves require plasticisers to achieve flexibility. These plasticisers may migrate under certain conditions, particularly in contact with fatty or oily substances, due to their affinity for lipophilic media.

For this reason, PVC gloves are generally not recommended for direct handling of fatty foodstuffs, depending on formulation and compliance with relevant food contact regulations.

*HARPS’ PVC gloves are manufactured without phthalates.*

Skin-friendliness / Allergies

Are powder-free gloves completely free of particles?

Due to technical restrictions in manufacturing processes, trace amounts of processing residues may still be present on powder-free gloves. However, these gloves are manufactured and processed to meet regulatory definitions for “powder-free” status.

According to all international standards, gloves are considered powder-free if the residual powder content does not exceed 2.0 mg per glove, measured using the specified test method.

How can one prevent a latex allergy from arising?

The most effective way to avoid the risk of sensitisation to natural rubber latex proteins is to avoid exposure to natural rubber latex altogether by using alternative materials such as nitrile, vinyl (PVC), chloroprene, or synthetic polyisoprene gloves.

Where natural rubber latex gloves are used, powder-free products with reduced extractable protein levels should be selected to minimise exposure. However, no glove made of natural rubber latex can be considered completely free of allergenic proteins.

In addition, good hand hygiene and skin care practices can also contribute to reduce the risk of latex allergies. Hands should be properly dried after washing before donning gloves. The regular use of suitable skin care products (i.e. water-based products) can help maintain the integrity of the skin barrier, which may support in reducing irritation and potential sensitisation pathways.

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

Natural rubber latex gloves undergo several intensive leaching and washing processes intended to reduce levels of extractable proteins. Despite these manufacturing steps, it is not technically possible to eliminate all latex proteins completely.

For this reason, residual protein levels may still be present and can pose a risk for sensitised individuals.

The most comprehensive guidance is provided in EN 455-3. Although this is a European standard, its scientific and methodological principles are relevant internationally. It recognises that it is not possible to define a scientifically valid “safe maximum” protein level for natural rubber latex products, as not all proteins are allergenic and allergenicity depends on the presence of specific protein structures (epitopes) and individual sensitisation profiles.

However, peer-reviewed literature supports that reducing levels of extractable (leachable) proteins contributes to a reduction in the overall risk of latex sensitisation and allergic reactions.

EN 455-3 further specifies that manufacturers may determine and declare extractable protein levels; however, it also acknowledges the inherent analytical variability of the test methods. Therefore, reported values must be considered in conjunction with method limitations and process variability. As a consequence, protein content claims below 50 µg/g are not considered reliable due to inter-laboratory variation and manufacturing variability.

Labelling requirements for natural rubber latex products require a clear indication of the presence of natural rubber latex, together with a warning that the product may cause allergic reactions in susceptible individuals.

What is the allergy potential of disposable gloves?

Allergic reactions associated with disposable gloves may arise via different mechanisms:

· Type I (immediate) hypersensitivity reactions are associated with exposure to natural rubber latex proteins and may occur in sensitized individuals. Responses to Type I allergens may vary and range from mild (e.g. rashes or erythems) to severe and life-threatening symptoms (e.g. anaphylactic shocks).

· Type IV (delayed) hypersensitivity reactions are typically associated with certain chemical (e.g. vulcanization accelerators like DPG, thiurams or dithiocarbamates) used in the manufacturing process of rubber-based gloves. Though typically the responses to Type IV allergens are less severe than reactions to Type I allergens, they are still among the primary culprits for occupational allergic contact dermatitis (OCD).

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 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.

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 filler is common in the glove industry and does not have a negative impact on glove properties, whereas the excessive use of fillers deteriorates a glove’s quality.In addition, further factors affecting glove quality include the quality of raw materials used, specific formulations, manufacturing process and quality inspection system.

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.

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 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.

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.

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@harpsglobal.com.
For information about the chemical resistance of our gloves visit the chemical resistance page.

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.

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.

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.

We're happy to advise you on our glove solutions

Our experts can help you find the right fit. If you still have product questions or inquiries, contact us today.

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