Cleanroom Gloves Cleanroom gloves (also known as cleanroom gloves) are protective gloves specifically designed for use in controlled manufacturing environments. They prevent contamination by particles, germs, and chemical residues, protecting both the product and the wearer. Cleanroom gloves differ from conventional laboratory or medical gloves in their elaborate post-cleaning process, documented particle shedding, low endotoxin levels, and packaging under defined cleanroom conditions (ISO 4 to ISO 5). They are indispensable in the pharmaceutical, semiconductor, biotechnology, medical technology, and optics industries.
For HEIN Reinraum You will find a comprehensive range of sterile and non-sterile cleanroom gloves made from Nitrile, latex, neoprene (polychloroprene), polyisoprene and Nylon – Tested for ISO cleanroom classes 3 to 9 and GMP grades A to D. All gloves are powder-free, post-cleaned, and supplied with complete batch documentation. In our in-house laboratory, we also test gloves according to your individual requirements – for example, for chemical resistance, permeation times, or ESD properties.
What types of cleanroom gloves are available? – An overview of materials
Choosing the right glove material depends on the cleanroom class, the application, and individual requirements. Each material has specific advantages and disadvantages regarding comfort, chemical resistance, particle shedding, and allergy potential.
Nitrile cleanroom gloves
Nitrile gloves Nitrile gloves are the most commonly used type of glove in cleanrooms. The synthetic rubber (nitrile butadiene, NBR) is latex-free and therefore free of natural latex proteins, which can trigger Type I allergies. Nitrile cleanroom gloves are characterized by low particle shedding, high tear resistance, very good chemical resistance, and an excellent fit. They are available in sterile and non-sterile versions and are suitable for cleanroom classes from ISO 3 to ISO 9 as well as GMP A/B to C/D. Many of our nitrile gloves are also accelerator-free, which eliminates the risk of a Type IV allergy.
Latex cleanroom gloves
Latex gloves Made from natural rubber, these gloves offer excellent tactile sensitivity and high elasticity – ideal for fine motor tasks in pharmaceuticals and biotechnology. The disadvantage: natural latex contains proteins that can trigger allergic reactions in sensitized individuals. Cleanroom latex gloves are powder-free and post-cleaned to minimize particle and protein contamination. They are suitable for cleanroom classes ISO 5 to ISO 9 and GMP C/D.
Neoprene cleanroom gloves (polychloroprene)
Neoprene gloves These gloves combine the advantages of latex (high elasticity, good wearing comfort) with the latex-free properties of nitrile. They offer high puncture resistance and chemical resistance and are particularly suitable as gloves in aseptic areas (GMP A/B). Sterile neoprene cleanroom gloves are frequently used as overgloves or undergloves and are certified for cleanroom classes from ISO 5 upwards.
Polyisoprene cleanroom gloves
Polyisoprene gloves These are synthetic alternatives to natural latex. They offer a virtually identical tactile feel and skin-like elasticity – without the allergy risk of natural rubber. Polyisoprene cleanroom gloves are suitable for highly sensitive applications in pharmaceuticals and medical technology and achieve a sterility assurance level (SAL) of 10⁻⁶.
Nylon and ESD gloves for cleanrooms
Nylon knitted gloves Gloves with a PU (polyurethane) coating are used as reusable cleanroom gloves in areas where electrostatic discharge (ESD) is critical – for example, in semiconductor and electronics manufacturing. ESD gloves with carbon or copper fibers dissipate electrostatic charges in a controlled manner, thus preventing damage to sensitive components. They are suitable for cleanroom classes ISO 6 to ISO 9 and GMP C/D.
insulator gloves
Insulating gloves Made from CSM (chlorosulfonated polyethylene), EPDM (ethylene propylene diene monomer rubber), or butyl rubber, these products are specifically designed for use in pharmaceutical isolators and containment systems. They offer superior chemical resistance, UV stability, and temperature resistance (up to 130 °C) and can withstand up to 60 autoclave cycles.
Cleanroom gloves according to ISO and GMP classification
The selection of the right glove depends primarily on the cleanroom class according to ISO 14644-1 and the GMP classification according to EU-GMP Annex 1The ISO standard classifies cleanrooms based on the maximum permissible particle concentration per cubic meter of air (ISO 1 = cleanest class, ISO 9 = lowest requirement). GMP grades (A to D) supplement this with microbiological requirements and process validation.
| Cleanroom class | GMP grade | Recommended glove type | Sterility | Typical application |
|---|---|---|---|---|
| ISO 3--4 | GMP A/B | Sterile nitrile or neoprene gloves, accelerator-free | Sterile | Aseptic filling, sterile manufacturing, isolators |
| ISO 5 | GMP A/B | Sterile nitrile, neoprene or polyisoprene gloves | Sterile | Pharmaceutical sterile production, medical technology |
| ISO 6--7 | GMP C/D | Non-sterile or sterile nitrile gloves | Sterile / Non-sterile | Pharmaceutical support areas, biotechnology, optics |
| ISO 8--9 | GMP D | Non-sterile nitrile or nylon gloves | Not sterile | Packaging, electronics manufacturing, general cleanrooms |
What are the key features of cleanroom gloves?
Particle emission and purity
Cleanroom gloves undergo extensive post-processing after manufacturing – through chlorination and decontamination with deionized water. Particle count, endotoxin levels, ion residues, and non-volatile residues (NVR) are documented batch-specifically. When comparing gloves, don't rely solely on product data sheets; request certificates of analysis for at least three different batches to obtain a reliable picture of the actual cleanliness.
Sterility and Sterility Assurance Level (SAL)
Sterile cleanroom gloves are additionally sterilized after cleaning (usually by gamma irradiation) and packaged in a controlled cleanroom environment (ISO 4–5). The Sterility Assurance Level (SAL) indicates the probability that a single glove will still carry viable microorganisms after sterilization – the standard in the pharmaceutical industry is SAL 10⁻⁶.
chemical resistance
For applications involving disinfectants, cytostatics, solvents, or aggressive chemicals, permeation resistance is crucial. The standards EN ISO 374-1 (Types A to C) and EN 16523-1 define test methods and classifications. Our in-house laboratory specifically tests gloves for your particular chemicals and provides customized product recommendations.
ESD protection (electrostatic discharge)
In semiconductor and electronics manufacturing, the controlled dissipation of electrostatic charges is essential. ESD-compliant cleanroom gloves according to EN 1149 and EN 16350 prevent uncontrolled discharges and protect sensitive components from damage.
comfort and fit
Cleanroom gloves are often worn for hours at a time. A good fit, high elasticity, and breathability are therefore crucial for staff acceptance and compliance with mask mandates. Hand-specific models (left/right) offer a more ergonomic fit than ambidextrous gloves.
How to put on cleanroom gloves correctly – The two-glove system
In many pharmaceutical cleanrooms of GMP grades A and B, a two-glove system is used: An inner glove (e.g., nitrile, orange) serves as the first barrier and is complemented by a sterile outer glove (e.g., neoprene or nitrile, white). The bright color of the inner glove makes any damage to the outer glove immediately visible. Donning is performed according to a defined SOP (Standard Operating Procedure) under aseptic conditions.
Standards and certifications for cleanroom gloves
- ISO-14644 1: 2015 – Classification of air cleanliness in cleanrooms (ISO 1–9)
- EU-GMP Annex 1 (2022) – Requirements for the manufacture of sterile medicinal products (Grades A–D)
- EN ISO 374-1:2016+A1:2018 – Protective gloves against chemicals (Type A, B, C)
- EN ISO 374-5: 2016 – Protection against microorganisms and viruses
- Regulation (EU) 2016/425 – Personal protective equipment (PPE), Category III
- EU Directive 93/42/EEC / MDR 2017/745 – Medical Devices Regulation
- EN 421: 2010 – Protective gloves against ionizing radiation and radioactive contamination
- EN 1149 / EN 16350 – Antistatic properties / ESD protection
- EN 16523-1:2015+A1:2018 – Permeation by chemicals
- ISO 16604: 2004 – Protection against contact with blood and bodily fluids
Why cleanroom gloves from HEIN Reinraum?
- Comprehensive product range: Sterile and non-sterile gloves made of nitrile, latex, neoprene, polyisoprene and nylon for all cleanroom classes (ISO 3–9, GMP A–D)
- In-house testing laboratory: Individual tests for chemical resistance, permeation times and ESD properties according to current standards
- Batch-specific documentation: Certificates of analysis including particle emission, endotoxin values and residue measurements
- Personal expert advice: Assistance in selecting the right glove for your specific application and cleanroom class
- Sampling: Free samples to test in your work environment
- Fast availability: Stock items and special orders via our 24/7 online shop
Frequently Asked Questions (FAQ) about cleanroom gloves
Cleanroom gloves are specially designed protective gloves for use in controlled environments (cleanrooms). After manufacturing, they undergo extensive post-cleaning, decontaminating, and packaging under cleanroom conditions. Unlike conventional laboratory or medical gloves, they exhibit documented low particle shedding, low endotoxin levels, and minimal chemical residues.
The best material depends on the application. Nitrile is the most versatile all-rounder with high chemical resistance and no allergy risk. Latex offers the best tactile feel for fine motor tasks. Neoprene It combines elasticity with latex-free properties and is suitable for aseptic areas. polyisoprene is the latex-free alternative with virtually identical wearing comfort. For ESD-sensitive areas Nylon-carbon gloves the right choice.
For ISO Class 5 and GMP Grade A/B, sterile, powder-free cleanroom gloves made of nitrile or neoprene are recommended. These gloves are accelerator-free and exhibit minimal particle shedding. Batch-specific documentation ensures they meet the stringent requirements of EU-GMP Annex 1 for aseptic processes.
Sterile cleanroom gloves are additionally sterilized after post-cleaning (e.g., by gamma irradiation) and supplied in pairs in sterile packaging. They achieve a sterility assurance level (SAL) of 10⁻⁶ and are mandatory for GMP A/B areas. Non-sterile cleanroom gloves are post-cleaned and have low particle counts, but are not sterilized – they are suitable for GMP C/D areas and general cleanroom applications.
Not all cleanroom gloves are latex-free. Gloves made of nitrile, neoprene, and polyisoprene are latex-free and do not contain natural latex proteins that trigger type I allergies. Latex cleanroom gloves made of natural rubber are still available and are preferred in certain applications due to their superior tactile sensitivity. Only latex-free models should be used in cases of known latex sensitization.
"Accelerator-free" means that no chemical accelerators (e.g., thiurams, dithiocarbamates) were used in the vulcanization of the glove material. These accelerators can trigger type IV allergies (contact allergies). Accelerator-free gloves therefore offer a minimal allergy risk and are particularly suitable for employees with sensitive skin or a known contact allergy.
The glove change frequency depends on the cleanroom class, the process, and internal SOPs. In GMP A/B areas, gloves are typically changed and disinfected after every aseptic procedure or at least every 30–60 minutes. In GMP C/D areas, the change interval may be longer. As a general rule, gloves must be changed immediately if there is visible damage, after contact with contaminated surfaces, or upon leaving the cleanroom.
Disposable cleanroom gloves are not intended for autoclaving. Reusable isolating gloves made of CSM or butyl rubber, on the other hand, are autoclavable and, depending on the model, can withstand up to 60 autoclave cycles. Sterilizability and the maximum number of cycles are documented in the respective product data sheet.
Cleanroom gloves and laboratory gloves are based on the same materials but differ in two key aspects: First, cleanroom gloves undergo extensive post-cleaning (decontamination with deionized water, chlorination) to minimize particles, powder residues, and chemical contaminants. Second, they are packaged under controlled cleanroom conditions (ISO 4-5) and supplied with batch-specific documentation on particle shedding, endotoxins, and residues. A laboratory glove without this post-processing is not suitable for use in classified cleanrooms.
Cleanroom gloves must meet various standards depending on their application: ISO 14644-1 (cleanroom classification), EU-GMP Annex 1 (pharmaceutical manufacturing), EN ISO 374-1/-5 (protection against chemicals and viruses), Regulation (EU) 2016/425 (PPE Category III), EN 421 (radiation protection), and EN 1149/EN 16350 (ESD protection). For contact with blood and bodily fluids, ISO 16604 also applies. Specific compliance with these standards is documented on the respective product data sheet and certificates of analysis.