Frequently Asked Questions

Tensile strength refers to the amount of force required to stretch a material until it breaks. In medical gloves, it is a key indicator of durability and tear resistance, ensuring the glove can withstand tension during use without compromising protection.

Meeting the minimum tensile strength requirements—such as those outlined in ASTM D3578 for latex gloves and ASTM D6319 for nitrile gloves—is essential for ensuring glove quality and user safety.

iNtouch™ gloves are manufactured to comply with internationally recognised standards for safety and performance.

• Surgical gloves meet EN455, ASTM D3577, and ISO 10282 standards.
• Sterile and non-sterile examination gloves meet EN455, ASTM D3578, and ISO 11193 standards.

These standards help ensure the gloves maintain adequate strength, durability, and protection during use.

Elongation at break refers to the ability of a glove material to stretch before tearing. It is measured as the percentage increase in length from its original form until breakage, indicating the material’s flexibility and durability.

Force at break measures the amount of force (in Newtons) a glove can withstand before breaking. It reflects the glove’s strength and durability. According to EN 455-2, the minimum force at break is:

• 9 N for surgical gloves
• 6 N for sterile and non-sterile examination gloves (after ageing)

Ergonomic fit describes how well a glove conforms to the natural shape and movement of the hand, promoting comfort and reducing strain. Poor fit — whether too tight or too loose—can lead to reduced dexterity, increased muscle fatigue, and higher injury risk.

Glove dexterity is the ability to perform precise tasks and fine motor movements while wearing gloves. High dexterity is crucial for maintaining control, efficiency, and safety during use.

A good grip ensures secure handling of tools and materials, reducing the risk of:

• Dropped or slipped objects
• Cuts and injuries due to poor control
• Proper grip enhances safety, accuracy, and productivity in both medical and industrial settings.

Medical gloves, particularly those made from natural rubber latex, may trigger allergic reactions due to the proteins in latex and chemical additives used during processing.

These reactions can range from mild skin irritation to serious hypersensitivity responses. Latex allergies are especially common among healthcare workers due to frequent glove use and exposure to aerosolised latex particles.

Type I allergy is an immediate hypersensitivity reaction caused by the natural proteins in latex. Symptoms can appear within minutes of contact and may include swelling, coughing, asthma, angioedema, or even anaphylaxis. This type of allergy is potentially life-threatening and requires immediate attention.

Type IV allergy is a delayed skin reaction caused by sensitisation to chemical residues—such as accelerators—used in glove manufacturing.

Though not life-threatening, it results in itching, redness, and blisters, followed by dryness and scaling during healing. Symptoms may appear hours to days after exposure.

Chemical accelerators are additives used in the vulcanisation process to bond rubber molecules, creating a strong, elastic glove film.

Common sulphur-based accelerators — such as dithiocarbamates, thiurams, and mercaptobenzothiazoles—are known to cause skin sensitisation and are a major cause of Type IV allergic reactions.

iNtouch™ addresses Type I allergies by offering powder-free latex surgical gloves, which reduce exposure to natural latex proteins—a common cause of immediate hypersensitivity. Eliminating powder also minimises the risk of airborne latex allergens, making the gloves safer for users with sensitivities.

To reduce Type IV allergies, iNtouch™ has developed the Nitrile LD glove series, featuring Low Derma (LD) Technology. This innovation is specifically engineered to minimise exposure to chemical accelerators, helping prevent delayed allergic skin reactions while ensuring comfort and safety for healthcare professionals.

Contact dermatitis is an inflammatory skin condition caused by direct contact with irritants or allergens. It is classified into:

• Irritant contact dermatitis: Caused by repeated exposure to substances that physically damage the skin.
• Allergic contact dermatitis: Triggered by an immune response to specific allergens, such as chemicals used in gloves.

Irritant contact dermatitis is the most common reaction to latex products. It results in dry, itchy, and irritated skin, typically on the hands. This is caused by friction, prolonged glove use, or glove powder and is not an allergic reaction.

Allergic contact dermatitis—also known as chemical sensitivity dermatitis—is caused by chemical additives used in the production of latex gloves. It presents as redness, itching, and rashes, similar to poison ivy, and is classified as a Type IV delayed hypersensitivity.

Low Derma (LD) Technology, developed in Malaysia, is a proprietary innovation used in Intouch gloves to provide advanced protection against Type I and Type IV allergies. By reducing exposure to both latex proteins and harmful chemical accelerators, LD Technology offers enhanced safety for users with sensitive skin or allergy risks.

Pyrogens are substances that can cause fever when introduced into the body. They are often derived from microorganisms, particularly from components like endotoxins or lipopolysaccharides (LPS). In high concentrations, pyrogens can trigger inflammation, septic shock, multi-organ failure, and even death.

Endotoxins are the most potent type of pyrogen. They are complex lipopolysaccharides (LPS) found in the outer membrane of gram-negative bacteria. Structurally, endotoxins consist of three main parts: the O-specific antigen, core polysaccharide, and lipid A (the toxic component).

Exposure to endotoxins may lead to serious health effects, including:

• Sepsis
• Infections
• Multi-organ failure
• Autoimmune diseases
• Typhoid fever
• Cardiovascular dysfunction
• Renal diseases
• Respiratory diseases
• Digestive system diseases
• Death in severe cases

Sepsis is a life-threatening condition caused by the body’s extreme response to an infection. It can lead to tissue damage, organ failure, and death if not promptly treated.

iNtouch™ gloves are manufactured under tightly controlled environmental conditions throughout the production and packaging process. This helps ensure minimal endotoxin levels and non-pyrogenic properties.

Under the European Medical Device Regulation (MDR) and EN 455-3 standards, gloves labeled “low endotoxin content” must contain no more than 20 endotoxin units (EU) per pair.

“Non-pyrogenic” refers to a product that has been manufactured or treated to eliminate or significantly reduce the presence of pyrogens, making it safe for medical use without causing fever or inflammation.

Look for the non-pyrogenic symbol, as defined in ISO 15223-1. This international symbol is commonly found on medical device packaging and indicates the product does not contain pyrogens. Using symbols helps avoid translation errors and promotes global safety and standardization.

Reference number of symbol

Title of Symbol

Non-pyrogenic.

Description of Symbol

Indicates a medical device that is non-pyrogenic.

iNtouch™ uses gamma irradiation — a sterilization process that applies high-energy gamma rays to destroy microorganisms by damaging their DNA, preventing reproduction and ensuring product safety.

EN455 Standards:
iNtouch™ gloves comply with EN 455, which ensures conformity in the following areas:

• EN 455-1: Freedom from holes
• EN 455-2: Physical properties such as tensile strength and elongation
• EN 455-3: Biological safety (e.g. endotoxin levels)
• EN 455-4: Shelf life and product stability

These standards support compliance with the Medical Device Regulation (MDR).
ASTM Standards:

• ASTM D3577: Surgical gloves (Latex)
• ASTM D3578: Non-sterile latex examination gloves
• ASTM D6319: Nitrile examination gloves (sterile or non-sterile)

ISO Standards:

• ISO 10282: Surgical gloves (Latex)
• ISO 11193-1: Examination gloves (Latex or Nitrile, single-use)

Quality Management Certifications:

• ISO 13485: Quality Management System for medical devices (required under MDR)
• ISO 9001: General QMS certification supporting good manufacturing practices

• Acceptance Quality Limit (AQL):
  Intouch surgical gloves have an AQL of 0.65, which is more stringent than the industry norm of 1.5. This ensures better quality and fewer defects.
• Endotoxin Control:
  Intouch surgical gloves meet EN 455-3 standards, maintaining < 20 Endotoxin Units (EU) per pair. Endotoxin testing is conducted for every shipment to ensure safety.

Acceptable Quality Limit (AQL) is an industry-standard statistical sampling method used to determine the allowable number of defects in a glove batch.

A lower AQL indicates higher product quality and fewer defects.

Common AQL Standards for Surgical Gloves:

For Examination Gloves:

EN ISO 374 is used to evaluate a glove’s resistance to specific chemicals, measuring:

• Permeation: Chemical movement through the glove material
• Degradation: Physical deterioration of the glove when exposed to chemicals

This ensures that the glove can protect users from hazardous chemical exposure.

ASTM F739 is commonly used to assess the resistance of glove materials to chemical permeation. It determines how long it takes for chemicals to pass through the glove material under continuous contact.

Under the Medical Device Regulation (MDR), medical gloves are classified by the level of risk they pose to patients:

• Class I: Non-sterile examination gloves – low risk
• Class Is: Sterile examination gloves – carry the same risk classification as Class I but must meet additional regulatory requirements because of their sterile nature
• Class IIa: Surgical gloves – higher risk due to their use in invasive procedures

Personal Protective Equipment (PPE) gloves are divided into three categories based on the level of protection:

• Category I: Protection against minimal risk (e.g. cleaning gloves)
• Category II: Protection against moderate risk
• Category III: Protection against serious or irreversible harm, such as chemical burns or biological hazards

To be classified as PPE, gloves must meet:

• EN 21420: General requirements, including:
• Sizing, length, comfort
• Material safety
• User information
• EN ISO 374: For gloves offering chemical protection. It covers:
• Penetration through holes or seams
• Chemical permeation through the glove material
• Degradation caused by chemical exposure

The Forest Stewardship Council (FSC™) is an international non-governmental organisation that promotes responsible management of the world’s forests. Since 1994, FSC™ has become the world’s leading forest certification system, covering over 200 million hectares globally.

Its certification enables businesses and consumers to identify and choose wood, paper, and forest-based products — such as natural rubber — that are sourced from sustainably managed forests.

FSC™ certification verifies that every stage of the supply chain, from forest to final product, follows responsible practices that:

• Prevent deforestation
• Protect biodiversity
• Uphold workers’ rights
• Respect Indigenous Peoples and local communities

In the case of rubber, FSC™-certified latex must be harvested according to FSC™’s Forest Management Standard, ensuring social and environmental accountability from source to glove.

The EU Deforestation Regulation (EUDR) is a European Union law designed to reduce deforestation and forest degradation linked to global supply chains. It requires companies to ensure that product such as rubber are not sourced from areas that have been deforested or degraded after a specified cut-off date.

FSC™ helps businesses meet EUDR requirements through:

• Verified sourcing from responsibly managed forests
• A robust Chain of Custody system for traceability
• Independent third-party audits
• Tools for risk assessment and due diligence documentation

For iNtouch™, FSC™ certification ensures that its natural rubber is legally sourced, sustainably managed, and deforestation-free, meeting the key criteria under EUDR.

Yes. iNtouch™ received 100% FSC™ Natural Rubber Resource certification in July 2023, affirming its commitment to sustainability. This certification ensures that all latex used in iNtouch™ gloves is:

• Derived from renewable, biodegradable raw materials
• Sourced from FSC™-certified plantations
• Produced with environmental and social responsibility

This achievement reflects iNtouch™’s ongoing dedication to minimising environmental impact while maintaining high-quality glove production.

iNtouch™ supports community development through its Project Smile initiative, aimed at nurturing socially conscious future leaders. Activities include:

• Educational field trips for kindergarten students
• Beach cleaning programmes
• Donations of essential supplies to underprivileged groups

Project Smile reinforces Intouch’s vision to contribute positively to society while instilling sustainability values in younger generations.

Learn more on our YouTube Channel or ‘About Us’ page.

Yes. iNtouch™ packaging is made from 95% recyclable materials and includes 80% post-consumer fibre (PCF).This reduces waste, supports a circular economy, and lowers the environmental footprint.

Post-consumer fibre packaging is made from materials that have already been used and recycled by consumers — such as paper, cardboard, or plastic film. These materials are processed and repurposed into new packaging, reducing the need for virgin resources.

PCF packaging provides several environmental benefits:

• Conserves natural resources by reducing demand for virgin raw materials
• Reduces landfill waste, pollution, and methane emissions
• Requires less energy and water during production
• Lowers greenhouse gas emissions
• Promotes recycling awareness and supports sustainable consumer bhaviour

By adopting PCF packaging, iNtouch™ contributes to a more sustainable, low-impact supply chain.