EN455-5:2025 in front of medical gloves.

Healthcare professionals worldwide face a long-standing safety concern that EN 455-5 aims to address. For years, healthcare workers have reported reactions to residual chemicals in medical gloves, ranging from mild irritation to severe contact dermatitis, including Type IV allergies.

The newly approved European Standard EN 455-5:2025 (approved by CEN on June 30, 2025) may seem groundbreaking at first, but testing for chemical residues in gloves is not new. Earlier studies often relied on simple water extractions, which underestimated actual chemical exposure. EN 455-5 corrects this by introducing standardized solvent-based methods, such as ethanol and acetone extractions.

Medical glove manufacturers have long followed testing requirements under EN 455-3 and its reference to EN ISO 10993-1. The key advancement in EN 455-5 is its harmonized method for measuring potentially harmful residues, detailing how to extract and quantify accelerators, activators, antioxidants, and donning aids. It requires using 75% ethanol in water for simulated-use extraction, followed by validated chromatographic separation for measurement. While it provides a precise testing framework, it does not define maximum allowable levels for these substances.

This article explains what EN 455-5:2025 brings to the table, how it links to existing standards, and what manufacturers and healthcare providers need to ensure compliance and safety.

What is EN455-5:2025 and Why It Matters

EN455-5:2025 is an important addition to the 20-year-old EN455 series. This new standard looks at chemical residues in medical gloves. Healthcare workers who use these protective items daily will now have this tool to compare products, and hopefully, face fewer chemical exposure risks in the future.

Overview of the EN455 Series for Medical Gloves

The EN455 series is the life-blood of quality testing for single-use medical gloves in Europe. These standards keep both patients and healthcare providers safe. When manufacturers follow these standards, they comply with EU legislation (Medical Device Regulation (EU) 2017/745). The series had four parts before EN455-5:

The Specific Focus on Extractable Chemical Residues

EN455-5:2025 introduces a standard way to measure leftover chemicals from glove manufacturing. It pays special attention to Type IV allergenic substances. This 26-page document shows how to detect and calculate chemical residues.

Though new, this standard tackles an old problem. Medical professionals have reported bad reactions to glove chemicals for years. These chemicals help make gloves but can cause issues. They include accelerators, activators, antioxidants, and donning aids. Reactions range from mild skin irritation to serious contact dermatitis, especially Type IV allergic responses.

The standard doesn’t check if these chemicals cause allergies or if they’re safe. Instead, it creates a standard method to extract and measure them. It spells out which extraction materials and methods to use, and how to measure residual chemicals.

Manufacturers now have a standardized tool to prove that their products are safe. Healthcare professionals get better protection from chemicals, which reduces their risk of reactions.

Timeline of Implementation and Compliance Requirements

EN455-5:2025’s implementation follows clear steps:

CEN approved the standard on June 30, 2025. The official publication came on August 27, 2025. All member nations must adopt this European Standard by February 2026. They can either publish the same text or endorse it.

Nations must drop any conflicting standards by February 2026. This creates one unified approach to testing medical gloves for chemical residues across Europe.

The standard acknowledges some practical challenges. Labs will need time to get accreditation after publication since this is the first version of EN455-5. Plans are already in place to update EN455-3 with new requirements related to EN455-5.

EN455-5:2025 standardizes how we test for chemical residues in medical gloves. Its detailed protocols and clear guidelines help protect healthcare workers who rely on these gloves. The standard gives manufacturers, quality teams, regulators, and healthcare facilities a great way to get the highest safety standards.

Understanding Chemical Residues in Medical Gloves

Medical gloves contain various chemical compounds that play a vital role in manufacturing but might put users’ health at risk. We need to understand these chemicals better to tap into the full potential of EN455-5:2025, which helps us calculate and measure their presence.

Common Chemicals Used in Glove Manufacturing

Chemical accelerators are among the most important groups of additives in medical gloves. We used them to improve vulcanization, the process that gives gloves their elasticity and durability. These compounds typically fit into three main categories:

  • Thiurams: Including Tetramethylthiuram Disulphide (TMTD) and Tetraethyl Thiuram Disulfide (TETD). These compounds cause about 80% of Type IV allergies linked to rubber products.
  • Dithiocarbamates: Such as Zinc Dibutyldithiocarbamate (ZDBC), Zinc Dimethyldithiocarbamates (ZDMC), and Zinc Diethyldithiocarbamates (ZDEC). These chemicals work as accelerators and show up in many fungicides.
  • Mercaptobenzothiazoles (MBT): Including Zinc Mercaptobenzothiazole (ZMBT) and Benzothiazyl Disulphide (MBTS). Research from 2005 found ZMBT in 9 out of 19 tested gloves, with levels between 0.15 and 1.5 µmol/g.

Manufacturers use other chemicals during production too. Antioxidants like phenolic compounds and amine derivatives help prevent rubber from breaking down and make gloves last longer. Coagulants such as calcium nitrate or polystyrene help latex become solid and stick to molds. Release agents like calcium stearate and cornstarch keep gloves from sticking to molds during manufacturing.

EN455-5 doesn’t add new testing requirements – medical gloves already needed chemical residue testing through EN455-3 and EN ISO 10993-1. The standard gives us a well-laid-out framework to extract and measure these substances.

Health Risks Associated with Chemical Residues

Chemical residues in gloves create significant workplace health issues, especially for healthcare workers who wear gloves often. Dermatitis makes up 35% of all workplace diseases, and contact dermatitis leads the pack.

A 2005 report by the Society for Investigative Dermatology and the American Academy of Dermatology showed that contact dermatitis led to more than 9 million doctor visits, costing over $1.40 billion to treat. Type IV allergies cause up to 28% of glove-related reactions, mostly because of chemical accelerators.

Several things affect reaction risk:

  • Chemical concentration and how easily it releases
  • How long and how often skin touches the glove
  • How the glove traps moisture against skin during use

Research on 23 patients with allergic contact dermatitis showed positive patch tests to one or more accelerators, including carbamates, thiurams, mercaptobenzothiazole, and diphenylguanidine. These reactions can change someone’s career path, but they rarely threaten lives like Type I reactions do.

Types of Allergic Reactions: Type I vs Type IV

Medical glove allergies usually come in two forms: Type I (immediate) and Type IV (delayed) hypersensitivity reactions.

Type I reactions happen right away, mainly due to natural rubber latex proteins. Symptoms show up within minutes and can include skin problems (itching, redness, hives), breathing issues, or in worst cases, anaphylactic shock. These reactions can spread throughout the body and become life-threatening.

Type IV reactions (allergic contact dermatitis) work differently:

  • Take 6-48 hours to show up
  • Stay where the glove touched
  • Involve cells rather than antibodies
  • Usually happen because of chemical accelerators, not latex proteins

Type IV symptoms start with redness, swelling, small blisters, and itching. If someone keeps getting exposed, they might develop dry skin, thickening, peeling, and open sores.

These differences matter because EN455-5 has a strong focus on chemicals that cause Type IV reactions. The standard lists many common contact allergens found in medical gloves, which helps manufacturers find and measure potentially harmful residues.

Key Components of the EN455-5 Standard

The EN455-5:2025 framework follows a logical structure. Its distinct components create a detailed approach to testing chemical residues in medical gloves. Let’s get into these components to understand how this standard creates a unified testing methodology across Europe.

Scope and Application

EN455-5:2025 specifies a test method to measure residual chemicals used in medical glove manufacturing. The focus lies on Type IV allergenic substances that remain after production. The standard gives detailed information about three critical elements: the extraction medium, extraction method, and quantitative assay procedures for residual chemicals.

The standard’s limitations are clear. EN455-5 makes no claims about allergenic potential, biological evaluation, or user safety. These boundaries show that while the standard provides testing methodologies, it doesn’t determine safety or biological compatibility.

The scope shows this standard focuses on measurement methodology. Safety thresholds or clinical relevance determinations are not part of its purview. This creates a standardized testing framework without specific pass/fail criteria based on residue quantities.

Normative References

EN455-5:2025 stands out among technical standards because it has no normative references. The document works independently without needing other standards for implementation.

Manufacturers and testing laboratories can apply EN455-5 directly. They don’t need to navigate multiple interdependent standards. Notwithstanding that, the standard remains part of the broader EN455 family. It connects to biological evaluation requirements in EN455-3 and EN ISO 10993-1.

Essential Terms and Definitions

Nine precisely defined terms create the standard’s technical vocabulary:

  1. Allergenic – Having potential to provoke allergic responses, specifically Type IV delayed contact dermatitis reactions
  2. Chemical – Substance added or formed during manufacturing, sterilization, or storage that remains available in the final product
  3. Curing agent – Chemical causing crosslinking, commonly sulfur in glove manufacturing
  4. Leachable – Substance released from a medical device during clinical use
  5. Extractable – Substance released when using laboratory extraction conditions
  6. Extraction medium – Solution or solvent used for extracting test articles
  7. Simulated-use extraction – Extraction method simulating clinical use conditions
  8. Contact allergen – Substance known/suspected to cause Type IV allergy
  9. Accelerator – Chemical catalyzing reactions necessary for curing/vulcanization

These definitions are the foundations of the standard’s requirements. To cite an instance, the “allergenic” definition limits its scope to Type IV delayed contact dermatitis reactions. This connects to Annex E, which lists relevant contact allergens commonly found in medical gloves.

Test Methods Overview

Test methods form the standard’s operational core. Laboratories must confirm and document all test methods used for conformity. No single assay can analyze every residual chemical, so the standard doesn’t specify a reference method.

Annex F explains the detailed test method’s rationale. Annex E provides guidance on assay methods for various chemicals. The standard designates Annex A as the required extraction method specification.

EN455-5 uses a simulated-use extraction procedure that shows the worst-case leachables profile. This is a big deal as it means that extractables levels equal or exceed leachables levels. The result will give a full picture of chemical residues.

The standard creates consistent testing methodologies without new testing requirements. Medical gloves have needed chemical residue testing through EN455-3 and EN ISO 10993-1. EN455-5’s contribution lies in providing specific, standardized extraction and measurement methods that European laboratories can apply consistently.

The Standardized Extraction Method

EN455-5:2025’s core strength lies in its standardized extraction method. This method forms the foundation for consistent chemical residue testing in laboratories. The extraction procedure helps measure residual chemicals that could trigger Type IV allergic responses in people who use medical gloves.

Simulated-Use Extraction Procedure

The standard uses a simulated-use extraction approach that shows both the type and amount of substances released from medical gloves during clinical use. This method creates an extractables profile showing the worst-case leachables scenario. The profile makes sure all substances that might leach during use are spotted as extractables, with each extractable at levels matching or exceeding their leachables.

This method works better than other extraction approaches. Results reflect real-life exposure scenarios instead of just theoretical possibilities. The standard’s development focused on consistency. Chemical residue testing requirements have been part of EN455-3 and its normative reference to EN ISO 10993-1 for years.

Before EN455-5:2025, some laboratories used water alone as an extraction medium, assuming it represented realistic clinical conditions. However, studies showed that pure water fails to extract many hydrophobic chemical residues, such as accelerators and antioxidants. The standard now prescribes 75 % ethanol in water as the only approved medium for “simulated-use” extraction because it more accurately reproduces the leaching that occurs on skin contact.

In addition to the simulated-use extraction, the standard also references an “exaggerated extraction” method, which can be performed using stronger organic solvents such as acetone. The acetone extraction is not part of the standardized EN 455-5 method but is mentioned in Annex F (§ F.5) as a tool for research or validation to determine the total extractable chemical content in gloves. It helps identify substances that may be encapsulated within the elastomer but still relevant for toxicological evaluation.

Equipment and Materials Required

Annex A details the extraction procedure’s equipment and materials. The extraction medium, 75% ethanol in water, stands out as a crucial component. Years of testing proved this solution works best to extract typical chemicals from medical gloves.

The basic equipment needed:

  • Analytical-grade ethanol (≥99.5%)
  • Ultrapure water
  • Calibrated glassware for precise measurements
  • Extraction vessels with appropriate sealing mechanisms
  • Temperature-controlled equipment for maintaining extraction conditions

Step-by-Step Extraction Process

Annex A of EN455-5 serves as the go-to reference for the extraction procedure. Manufacturers and testing labs get complete step-by-step guidance. No single method can analyze every possible residual chemical. That’s why the standard only specifies the extraction procedure itself.

The extraction technique needs precise timing, temperature control, and specific agitation parameters. Labs can then reproduce results reliably. After extraction, labs must use proper analytical techniques,usually chromatographic separation methods, to detect and measure specific chemical residues.

Table E.1 in Annex E lists examples of suitable assay methods for various concerning chemicals. These methods help detect accelerators like ZDEC and ZDBC, plus antioxidants such as Wingstay L.

Quality Control Measures

Labs must validate and document all test methods they use to show conformity with EN455-5. This rule ensures reliable and reproducible results across testing facilities. Annex F explains the science behind these procedural requirements. This helps labs understand why each step matters.

Labs getting ready for EN455-5 testing need to create validation protocols for their instruments and methods. The standard gives labs several months after publication to get accreditation and start offering accredited testing.

The standardized extraction procedure and quality control measures create a solid system. This system helps assess extractable chemical residues in medical gloves consistently throughout Europe without adding completely new testing requirements.

Chemical Analysis Techniques in EN455-5

Chemical residue extraction requires precise analytical methods to identify and measure compounds accurately. EN455-5:2025 describes several approaches to analyze these extracts and focuses on chromatographic techniques.

High Performance Liquid Chromatography (HPLC) Methods

EN455-5:2025’s informative annexes B, C, and D outline three distinct HPLC methods. Laboratories can use these analytical approaches to detect and measure various chemical residues from medical gloves. No single assay can analyze every potential residual chemical, which explains why the standard offers multiple methods.

Laboratories performing the analysis must verify and document all test methods used to show conformity. This requirement will give consistent and reliable results across different testing facilities. Table E.1 in Annex E lists examples of suitable assay methods used for various chemicals of interest.

Detection and Quantification of Accelerators like ZDEC and ZDBC

Medical gloves contain zinc diethyldithiocarbamate (ZDEC) and zinc dibutyldithiocarbamate (ZDBC) as prominent contact allergens. EN455-5 standard provides specific methods to detect and quantify these through chromatographic separation.

HPLC analysis with appropriate detection systems follows the extraction with 75% ethanol in water specified in Annex A. The standard’s methods can detect and measure these compounds at concentrations that matter for potential allergic reactions.

Analysis of Antioxidants including Wingstay L

The standard outlines specific analytical approaches for antioxidants like Wingstay L. This highly effective polyphenol antioxidant works well with natural and synthetic polymer-based articles. It protects products from degradation and discoloration during processing and storage.

Wingstay L works better than other antioxidants like BHT and 2246. Research shows that 0.75 phr (parts per hundred rubber) of Wingstay L maintains good tensile properties in gloves. Accurate measurement of Wingstay L residues becomes crucial because of its widespread use and its reproductive toxic potential.

Among antioxidants, Wingstay L deserves special attention. While it is a highly effective stabilizer that prevents polymer degradation, it is also classified under EU REACH and CLP regulations as a reproductive toxicant. This means its residues require close monitoring and transparent declaration under EN 455-5 testing.

The standard’s chromatographic methods (Annex B and C) allow quantitative measurement of Wingstay L at trace levels following extraction with 75 % ethanol or, where validation is needed, by acetone extraction.

Interpretation of Test Results

Laboratories must interpret results using verified methods after completing the analytical procedures. EN455-5 doesn’t set maximum allowable limits for chemical residues. Instead, it creates a framework to measure consistently.

Result interpretation typically involves:

  1. Comparing detected levels against established baselines
  2. Evaluating the results in context of known allergen thresholds
  3. Assessing the overall chemical profile against product specifications

This analytical framework adds no new testing requirements. EN455-3 and its normative reference to EN ISO 10993-1 have required chemical residue testing for medical gloves for years. EN455-5 adds a standardized approach to extraction and measurement.

These standardized analytical techniques help manufacturers assess their products consistently. Healthcare providers can make better decisions about glove selection based on chemical residue profiles.

Known Contact Allergens in Medical Gloves

Chemical additives in medical glove manufacturing are the most important source of Type IV allergic reactions among healthcare workers. These substances work as vulcanization agents and processing aids, and can leave residues in the finished product. The EN455-5 standard gives us a framework to measure these residual chemicals consistently, building on requirements that are the foundations of EN455-3 and EN ISO 10993-1.

Thiurams and Dithiocarbamates

Thiurams stood out as major contact allergens in medical gloves. This family of chemicals has Tetramethylthiuram Disulphide (TMTD) and Tetraethyl Thiuram Disulfide (TETD), which caused about 80% of Type IV allergies linked to rubber products. Experts called thiurams the most sensitizing accelerators in gloves.

Dithiocarbamates have taken the place of thiurams in manufacturing processes. You’ll find common examples like Zinc Diethyldithiocarbamate (ZDEC), Zinc Dibutyldithiocarbamate (ZDBC), and Zinc dimethyldithiocarbamate (ZDMC). These compounds work double duty as accelerators and fungicides.

The relationship between thiurams and dithiocarbamates as a redox pair brings up some fascinating chemistry. Dithiocarbamates can turn into thiurams through iron ion catalysis, while thiurams can become dithiocarbamates through glutathione interaction. This explains why some patients react to both groups of chemicals.

Mercaptobenzothiazoles and Derivatives

Mercaptobenzothiazole (MBT) and its derivatives make up another major group of rubber accelerators. This family has Zinc Mercaptobenzothiazole (ZMBT) and 2,2′-Dithiobis(benzothiazole) (MBTS). Contact allergies to MBT are nowhere near as common as they used to be.

MBT’s allergenic potential comes from its thiol group. This group changes to MBTS when exposed to hypochlorous acid, iodine, or hydrogen peroxide. MBTS then forms mixed disulfides with protein cysteinyl residues, especially on Cys34 of human serum albumin. This protein haptenation mechanism triggers allergic responses.

A newer study, published in 2005 by researchers testing rubber products, found ZMBT in 9 out of 19 gloves. The concentrations ranged from 0.15 to 1.5 µmol/g of glove material. Yet another clinical study showed only 2 out of 23 patients (9%) with allergic contact dermatitis reacted positively to MBT.

Guanidines and Other Additives

Guanidines, especially 1,3-diphenylguanidine (DPG), have become increasingly concerning allergens. DPG wasn’t considered a major contact allergen before manufacturers switched from latex to synthetic rubber gloves. The increased use of (poly)chloroprene/isoprene and butyl gloves has led to more DPG exposure.

A Belgian study from 2010-2017 revealed striking results. Healthcare workers with hand dermatitis showed 86% positive reactions to DPG, while only 30% reacted to thiuram mix. Half of these workers also reacted positively to gloves containing DPG.

Thioureas are slow accelerators that manufacturers rarely use in gloves. Contact allergies to thioureas don’t happen often. The EN455-5 standard helps measure these and other chemical residues completely.

Threshold Levels and Safety Considerations

Three main factors affect the risk of allergic reactions to glove chemicals:

  • Chemical concentration and how easily it releases
  • How long and how often skin contact occurs
  • The way gloves trap substances against skin

Alcoholic hand disinfectants used before putting on gloves can make chemical exposure worse. Research showed that alcoholic disinfectant increased DPG exposure from polyisoprene gloves. What’s more concerning is that 84% of DPG leaked into artificial sweat within just 10 minutes of wearing gloves.

Accelerator-free gloves offer a safe solution. The Belgian study proved this point – none of the subjects reacted to these gloves, making them perfect for people with sensitivities.

EN455-5’s standardized extraction and measurement methods let manufacturers measure these allergens consistently. This helps healthcare providers choose gloves based on reliable chemical residue information.

Relationship Between EN455-5 and Previous Standards

The new EN455-5:2025 represents one of the most important developments in medical glove standards. However, we should see this as progress rather than a complete overhaul of testing requirements.

How EN455-5 Builds Upon EN455-3 Requirements

The developers of EN455-5 had a clear plan to integrate it with existing standards. When EN455-5 was published, they already planned to revise EN455-3 to include additional requirements related to EN455-5. This well-thought-out connection will give consistency throughout the EN455 series.

EN455-3 has set requirements for biological safety evaluation of medical gloves, including labeling and test method information. The latest version, EN455-3:2023, replaces EN455-3:2015, which will expire on November 29, 2025. This planned overlap gives manufacturers enough time to transition between standards.

Connection to EN ISO 10993-1 for Biological Evaluation

EN455-5 works as part of a larger risk management process aligned with the EN ISO 10993 series. This link matters because the EN ISO 10993 series defines requirements and test methods for biological evaluation of medical devices.

What’s New vs. What’s Continued from Previous Standards

The main breakthrough in EN455-5 is its standardized method to measure potentially harmful residual extractable chemicals quantitatively. The need to test for chemical residues isn’t new – medical gloves have needed such testing through EN455-3 and EN ISO 10993-1 for years.

EN455-5 delivers:

  • A specific test method for measuring residual chemicals
  • Information on extraction medium, extraction methods, and quantitative assay procedures
  • Focus on Type IV allergenic substances

The standard doesn’t cover allergenic potential, biological evaluation, or user safety. Other standards in the regulatory framework continue to address these aspects.

EN455-5:2025 refines existing requirements rather than creating new obligations for manufacturers.

Implications for Manufacturers and Healthcare Providers

The new EN455-5:2025 standard brings practical changes that affect both manufacturers and healthcare facilities. They need to adapt to new protocols, though the existing testing requirements remain largely unchanged.

Documentation and Reporting Requirements

EN455-5 requires manufacturers to keep chemical levels as low as possible and maintain test results for reference. Anyone can ask for test results and details about testing methods. Products that make specific claims about chemical content must list chemical names on packaging according to EN455-5:2025 Table E.1. The process limits measured by standard methods must also appear. These requirements help create transparency across the supply chain.

Impact on Manufacturing Processes

EN455-5 doesn’t create new testing rules – it just standardizes existing frameworks. Medical gloves already needed chemical residue testing through EN455-3 and EN ISO 10993-1. The standard recognizes that manufacturers need time to adjust. Labs will take several months after publication to get accreditation and start testing to the new standard. This shows a practical approach to regulation.

Considerations for Procurement and Selection of Medical Gloves

The standardized approach of EN455-5 helps healthcare facilities evaluate products better. Procurement teams can now make evidence-based decisions using consistent chemical residue data. Three factors determine reaction risk: how much chemical can be released, how long skin contact lasts, and how the glove interacts with skin during use. Understanding these elements helps teams make smart purchasing choices that could reduce Type IV allergic reactions among staff.

Future Developments and Potential Updates

EN455-5 will change over time. Plans to revise EN455-3 were already in place when EN455-5 was published. The European Standard now has national standard status, and everyone must implement it by February 2026. After this date, conflicting national standards won’t apply. As testing becomes more standardized, manufacturers might develop better formulations with fewer chemical residues. This should make gloves safer to use.

Conclusion

This piece explores the new European Standard EN455-5:2025. The standard sets testing methods to measure extractable chemical residues in medical gloves. It marks a vital step forward, not by introducing new testing requirements but by providing a uniform framework to measure harmful chemicals consistently.

Healthcare professionals need to know that EN455-5 makes official what has been required for years. Medical gloves have undergone chemical residue testing through EN455-3 and its normative reference to EN ISO 10993-1. The changes now focus on specific methodology. The standard uses 75% ethanol in water for extraction and verified chromatographic separation methods.

This standardization helps everyone involved. Manufacturers now have clear testing procedures. European laboratories will follow the same protocols, which ensures comparable results from any location. Healthcare facilities can make better buying decisions based on reliable, standardized chemical residue profiles.

Type IV allergic reactions are the most important occupational health concern for medical professionals who use gloves every day. The chemicals measured through EN455-5 protocols relate directly to these allergic responses. These include thiurams, dithiocarbamates, mercaptobenzothiazoles, and guanidines. Standardized measurement helps identify and reduce exposure risks.

Notwithstanding that, the standard has several limitations. EN455-5 considers avoiding maximum allowable levels for chemical residues. It doesn’t make determinations about allergenic potential or biological safety. Other parts of the regulatory framework still handle these aspects.

The transition period until February 2026 gives manufacturers and testing laboratories enough time to adapt. The planned revision of EN455-3 will likely add more requirements related to EN455-5 during this time. This creates a more unified regulatory approach.

Without doubt, as implementation moves forward, we might see innovation in manufacturing processes that reduce chemical residues. This could decrease Type IV allergic reactions among healthcare workers. While not revolutionary in its requirements, EN455-5 forms the foundations for consistent quality assessment. This ended up enhancing safety for millions of healthcare professionals who depend on medical gloves daily.

FAQs

Q1. What is EN455-5:2025 and why is it important? EN455-5:2025 is a European standard that specifies test methods for measuring residual chemicals in medical gloves, particularly those that may cause Type IV allergic reactions. It’s important because it standardizes the extraction and measurement of potentially harmful chemicals, allowing for consistent testing across Europe.

Q2. How does EN455-5:2025 differ from previous standards? While EN455-5:2025 doesn’t introduce new testing requirements, it provides a standardized framework for extraction and measurement methods. It builds upon existing standards like EN455-3 and EN ISO 10993-1, offering specific protocols for quantifying chemical residues in medical gloves.

Q3. What are the main chemical allergens addressed by EN455-5:2025? The standard focuses on several known contact allergens in medical gloves, including thiurams, dithiocarbamates, mercaptobenzothiazoles, and guanidines. These chemicals are commonly used as accelerators and processing aids in glove manufacturing.

Q4. How will EN455-5:2025 affect healthcare providers? Healthcare providers will benefit from more consistent and reliable information about chemical residues in medical gloves. This standardized approach will enable them to make more informed decisions when selecting gloves, potentially reducing the risk of Type IV allergic reactions among staff.