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What is Cleanroom Glove?

 

 

Cleanroom gloves are specialized gloves designed to be worn in controlled environments, such as cleanrooms, laboratories, and manufacturing facilities where precision and contamination control are critical. These gloves are made from materials that meet stringent requirements for particulate and chemical resistance to prevent contamination of sensitive products or processes. Common materials used for cleanroom gloves include natural rubber latex, nitrile, neoprene, and polymers like TPE (Thermoplastic Elastomer).

  • Palm Fit Gloves
    Palm Fit Gloves are seamless knitted nylon gloves with urethane resin coating on the palm side, it use to cleanroom environments.
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  • ESD Gloves For Electronics
    ESD Gloves for Electronics is manufactured from 100% polyester with conductive carbon fiber every 10mm.Can be used in an EPA
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  • ESD Dotted Gloves
    ESD Dotted Gloves with non-slip properties, good elasticity and good ventilation, great for use in microelectronics, assembly and packing.
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  • Coated Knit Gloves
    Coated Knit Gloves of top fit are knitted with 100% pure polyester yarns and finger tips coating polyurethane.suitable to cleanroom and electrostatic sensitive environments.
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  • Nylon Coated Gloves
    Nylon Coated Gloves of top fit are manufacture from 100% pure nylon yarns with polyurethane coat finger tips,applications to electronic and computer assembly,quality control,inspection,general
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  • PU Coated Nylon Gloves
    PU Coated Nylon Gloves of top fit is manufactured from pure nylon yarns with PU coat for finger tips.it is suitable apply to cleanroom and electrostatic sensitive area.
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  • Nylon PU Coated Gloves
    Nylon PU Coated Gloves of top fit are made from nylon yarns and polyurethane coated fingertips,it can use to cleanroom and esd environment
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  • PU Palm Gloves
    PU Palm Gloves is made from pure polyester yarns and palm coating polyurethane ,apply to cleanroom or ESD environment.
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  • PU Palm Dip Gloves
    PU Palm Dip Gloves are construction form Seamless white polyester knit liner with white polyurethane coating,suitable to cleanroom or anti-static products production line.
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  • Polyurethane Coated Work Gloves
    Polyurethane Coated Work Gloves of ESD contains a carbon filament and has a Polyurethane (PU) coating on the finger tip sections,apply to Electronics assembly,Inspecting static sensitive
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  • Polyurethane Palm Coated Gloves
    Polyurethane Palm Coated Gloves are 100% pure polyester yarn,the palm of coating of polyurethance.use to cleanroom environment and static environment.
    read more
  • PU Palm Coated Gloves
    PU Palm Coated Gloves are manufactured from 100% pure polyester and palm of coated polyurethane, it suitable use to cleanroom or static environments.
    read more
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Cleanroom gloves why length matters

 

Cleanroom gloves are designed to protect either products from contamination or the wearer from exposure to chemicals. Once the main reason for wearing the gloves is established, there are many other glove characteristics to be considered – the required tactility, dexterity, antistatic materials etc. In addition, glove length is a factor that is becoming increasingly important.

 

The popularity of longer length cleanroom gloves is a result of increased awareness and need for extra personal or product protection, along with a drive to cut costs and reduce environmental impact.

 

The traditional length of a glove used in a cleanroom is 300mm/12 inches (12”). However, when handling hazardous chemicals, such as chemotherapy drugs, the wearer should have the increased protection and reassurance from a glove that is 400mm/16” in length, ensuring the entire forearm up to the elbow is covered and protected from the risk of exposure to harmful chemicals.

 

Product protection is also of the utmost importance; coverage up to the elbow, with a beaded cuff for a more secure fit on the arm, means 400mm/16” gloves eliminate the risk of contamination from exposed skin between the gloves and the cleanroom garment. Using cleanroom gloves that are 33% longer than the industry standard removes the need for additional protective items such as sleeve-covers or the use of cuff tape, thereby saving costs and reducing waste, resulting in a positive impact on the environment.

 

Cleanroom Glove Cleanliness And Standards

 

 

To help with glove selection, glove manufacturers specify the cleanliness class for which the glove is suitable (as defined in EN ISO 14644-11) e.g. ISO Class 4, 5 or 6. Additionally, they use the protective glove standards EN 4202 to define dimensions, EN 3743,4,5 the number of pinholes allowable and the medical glove standard EN 4556 to define the glove strength as a basis for quality assurance and quality control in their factories.

 

Gloves chosen to protect the wearer from harmful chemicals are classed as Personal Protective Equipment (PPE) and are regulated under the European PPE Directive7 and its associated standards8. The harmonised standards covering gloves used for chemical protection are EN 420 and EN 374. Obviously such gloves must at the same time comply with cleanroom requirements.

 

Protective gloves (PPE) form a physical barrier between the wearer and the chemicals that they are handling and will remain effective until the barrier is broken. The barrier can be breached via one of two mechanisms; permeation or penetration.

 

Permeation is the process by which a chemical moves through a protective glove material on a molecular level, whereas penetration is the movement of a chemical and/or micro-organism through porous materials, seams, pinholes or other imperfections in a protective glove material on a non-molecular level. BioClean 400mm/16” gloves have been tested under EN 374-3 to assess how effective they are against specified chemicals. To be compliant in offering chemical protection, the glove under test must be graded as offering Level 2 protection or higher against at least three chemicals. The performance levels are defined by the time taken for the test chemical to permeate the test sample.

 

The BioClean range of 400mm/16” cleanroom gloves all meet the required protection Level 2 and are suitable for use within the pharmaceutical, life sciences and microelectronics industries, complying with the requirements of the glove standard EN 420, EN 374-1, 2 & 3:2003 and medical glove standard EN 455.

The Importance Of The Cleanroom Glove Manufacturing Process
 

Glove Former Preparation
BioClean glove formers are meticulously prepared, going through numerous acid, water and alkaline washes, as well as heavy brushing to ensure they are particle free. The formers are then dipped into coagulant which is made up of calcium nitrate and a powder-free chemical (which will aid the glove being stripped off the former). The coagulant aids the pick-up of the raw material at the next stage.

 

Glove Dipping Process
This stage is the process of ‘dipping’ the formers into the raw material (latex, nitrile or polychloroprene) to make the final BioClean gloves. The raw material is kept at a low temperature in state-of-the-art dipping tanks to stop the raw material becoming destabilized. Once the formers have been dipped they pass through the gelling oven to partially solidify the raw material onto the formers. They then go through extensive leaching in hot water tanks in order to remove the water-soluble processing chemicals. The gloves are then beaded before entering the vulcanization oven. After the gloves are fully vulcanized they then proceed to the next stage.

 

On-line Chlorination & Stripping
The gloves are cooled, after the high temperatures of vulcanized drying oven, by going through three cooling tanks, and then passing through on-line chlorination (water containing chlorine). The chlorine reacts with the surface of the glove and changes the molecular structure, turning it from extremely tacky to silky smooth, this enables quick and easy donning (as this will be the inside of the glove)! The gloves are then semi-automatically stripped from the formers. When the gloves are completely stripped from the former they will be the correct way round. After stripping, BioClean gloves undergoes extensive testing and further off-line chlorination.

 

Glove Testing
BioClean cleanroom gloves go through watertight testing where they are filled with a litre of water and left for a couple of minutes. The operator then squeezes the gloves to ensure there are no holes (a hole can be so small that the amount of water escaping is almost undetectable unless the filled glove is squeezed). The gloves strength is then tested on a tensile testing machine to establish the force at break and elongation. Although powder-free, the outside surface of the glove (which was the inside when on the former) still needs to be chlorinated which is achieved by off-line chlorination. The gloves are put into a chlorinator, with water containing chlorine, to chlorinate the outside surface. The chlorine reacts with the surface of the gloves and changes the molecular structure, turning them from extremely tacky to smooth - the higher the concentration of the chlorine the smoother the glove becomes. The gloves are then thoroughly rinsed before going to the cleanroom for final processing.

 

Cleanroom Processing
After chlorination, the gloves are put into a double sided 100kg stainless steel washing machine, from outside the cleanroom. After a minimum of 3 washes in di-ionized, UV treated water, filtered to 0.2 micron, the gloves are removed from the washing machine on the cleanroom side, put into a dryer and dried using very high quality HEPA filtered air. Meanwhile, the EasyTear PE glove pouches are printed with lot number, expiry date and size using IPA resistant ink. After drying the gloves are then taken into our own ISO Class 4 or 5 cleanroom for packing.

 

Cleanroom Packing
Following the dipping, drying, chlorination, testing and processing, the end of the gloves journey is near! The final stage is packing which takes place within our ISO Class 4 or 5 cleanrooms where the air is filtered through ultra-low particulate (ULPA) air filters in the ceiling with 550 air changes an hour; that’s a change of air every six seconds! The air flows through holes in the floor then up between the wall panels and back through the ULPA filters. Before being pair-packed, the gloves will have a final inspection over a lightbox before they are packed into an PE inner wallet marked with L & R (hand specific gloves only) for easy recognition when donning. The inner wallet is then put into a PE EasyTear pouch which is vacuum sealed. Ten pouches (of sterile gloves) are packed into an EasyTear outer bag, the packer ID is put on the outer bag for easy traceability and an irradiation dot will be placed on the outside of the outer bag, the outer bag is then impulse sealed. The outer bags are then packed into a carton liner, the full carton liner is then placed in the pass box of the cleanroom and the hatch closed before they are collected from the other side. The full carton liner is then put into a carton which is taped on all edges to ensure it is sealed completely ready for sterilization and shipping to our customers… this completes the end of the BioClean glove journey.

The Benefits Of Longer Cleanroom Gloves

There are several benefits to using longer cleanroom gloves. These benefits include:

Extended protection

Long-length gloves provide more coverage for the arms, which can help to prevent contamination and exposure to harmful chemicals.

01

Reduced risk of contamination

Long-length gloves create a more substantial physical barrier between the wearer's skin and the controlled environment. This can help to reduce the risk of particulate contamination.

02

Elimination of additional protective items

Long-length gloves can eliminate the need for extra protective gear like sleeve covers or cuff tape.

03

Environmental benefits

Long-length gloves can help to reduce environmental impact by eliminating the need for additional protective gear and reduce packaging waste.

04

 

 
Tips For Selecting The Right Cleanroom Gloves
1. Form a Selection Group

Many people stuck in selecting and qualifying new product to be used in the cleanroom. To make the purchasing goes well, production managers, engineers, cleanroom materials specialists, and purchasing should all involve. Make sure the gloves does not violate any health regulations and fulfill international standard. Users will then provide feedback on comfort and dexterity issues after using the glove.

2. Carefully consider your process/products

AEach cleanroom in every industry has different requirement. When choosing gloves, look for the label on the gloves to match your cleanroom classification you operate. A normal process of producing cleanroom gloves should go through compounding special formulation, dipping, glove curing, stripping, surface treatment, laundry and drying, and packaging. If you operate in a sterile environment, it can completely removes or destroy viable organisms. They are packaged in cleanroom before sending for sterilization.

3. Evaluate Glove's Performance

Some cleanroom environment like electronics, semiconductor, and nanotechnology are sensitive to static. To evaluate the glove's performance, the manufacturer should go through several tests such as electrostatic discharge test, powder residue test, tensile strength analysis, and water leak test. Durability and tensile strength are two important features to consider when choosing cleanroom gloves.
The comfort of glove is also part of consideration. A comfort glove is soft and stretchy when wearing it. Some people prefer wearing a comfort glove while some works go well with ambidextrous gloves. To make sure you can hold the items easily without slipping, the tacking level is also very important. There are designs with texture on fingertips or adding slick grip on it.
The comfort and strength can be influence by the glove's material too. Latex gloves are more comfortable while nitrile gloves have more strength and avoid problems of latex allergies. Some manufacturers use nitrile based technology to combine the comfort of latex and strength of nitrile for gloves. To make sure the users have the best experience with the gloves produced, most of the suppliers provide a range of glove size with different length.

4. Demand certification

Also, the certification of glove examination is something we should not neglect. Make sure the supplier provide certificates of each product, such as particle counts, extractable counts, trend data, specification sheets, and irradiation certificates. Riverstone are certified with ISO9001:2008, ISO 14001:2004 and ISO 13485:2003. You can also access our FDA and Canadian General Standard Bureau (CGSB) certification 24/7 on our website.

5. The proof is in the packaging

When mentioned about cleanroom, the design, operator procedures, correct cleaning and sanitization are critical. All the items should be controlled, cleaned, and monitored to avoid contamination happened. Cleanroom gloves should be packaged in cleamroom with plastic bag, pr additional with coated paper in the individual pair packages.

 

Processing Flow Of Cleanroom Gloves
 

Glove Forming Preparation

Hand molds are sequentially soaked in acid, water, alkali solution, and scrubbed with 16 sets of nylon brushes to thoroughly clean any impurities remaining on the molds.

Immersion Forming and Vulcanization

The surface of the hand molds is evenly immersed in a mixture of coagulant, followed by two immersions in the prepared latex, forming a film. Afterward, the gloves are subjected to high-temperature vulcanization, with excess soluble harmful substances and particles removed through hot drainage.

Chlorination

After high-temperature vulcanization in a drying oven, the gloves are cooled through four cooling tanks. They are then treated with chlorine water at a concentration of 300-600 ppm online to ensure comfortable wearability. After five online treatments, the gloves are drained to ensure a clean surface.

Secondary Chlorination

After demolding, the gloves are inverted from the inside out, and the external surface needs a second offline chlorination to ensure smoothness and cleanliness.

Glove Testing

Various tests are conducted, including pinhole, appearance, mechanical performance, and monitoring of each tank condition. If the results are below the AQL value, production is immediately stopped. Tests include water leak resistance (ASTM D5151), physical performance (ASTM D412), and powder residue (ASTM D6124).

Cleanroom Processing

After chlorination, the gloves are transferred from the cleanroom to a stainless steel washer. They are washed multiple times in filtered double deionized water down to 0.2 micrometers using ultraviolet treatment. The gloves are then removed from the washer on the cleanroom side and placed in a dryer, where they are dried with high-quality HEPA-filtered air. Once dry, the gloves are taken into our own ISO 4 or 5 cleanroom for packaging.

 

Cleanroom Glove Substrates
 
 
Natural Rubber Latex

Latex is the most commonly used material for gloves because it is durable, comfortable, and allows for excellent dexterity. Made from organic tree saps, it protects well against ketones, different types of alcohol, and acids. Some people are allergic to the proteins in latex and must use an alternative glove material.

 
Nitrile (Acrylonitrile Butadiene Rubber)

Nitrile is the allergen-free alternative to natural latex and offers protection from more substances as well. These gloves can reduce fatigue because of a snugger fit than latex. They are resistant to punctures, scrapes, and cuts, and are anti-static.

 
Polyvinylchloride (PVC)

This inexpensive material is naturally low in particulates and works well in dry controlled environments. These gloves don’t have the tight fit of late or nitrile gloves, so they offer less dexterity than the others.

 
Neoprene

Ideal for individuals with sensitivities to latex and nitrile, neoprene gloves provide enhanced protection against a variety of chemicals. They have better puncture resistance than latex.

 

 

Certifications
 

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Our Factory

Manufacture and export of sterile cleanroom wipes,pre-saturate cleanroom wipes,cleanroom wipes,anti-static cleanroom wipes,cleanroom swabs, cleanroom paper, sticky mat, sticky roller, cleanroom notebooks, anti-static cleanroom garments, antistatic packaging bags, pharmaceutical sterilized consumable and many more. These products are widely applied in the biologics, pharmaceutical, microelectronics,semiconductor,precision optics,precise instruments, aerospace, automobile, electronic, photovoltaic and other related industries.

pharmaceutical cleanroom crtical cleaning solutions

 

 
FAQ

Q: What is Cleanroom Glove?

A: Cleanroom gloves are specialized gloves designed to be worn in controlled environments, such as cleanrooms, laboratories, and manufacturing facilities where precision and contamination control are critical. These gloves are made from materials that meet stringent requirements for particulate and chemical resistance to prevent contamination of sensitive products or processes.

Q: How long do cleanroom gloves last?

A: The shelf life of cleanroom gloves varies depending on the material and storage conditions, but most have an expiration date typically around 2-3 years from the date of manufacture.

Q: Do cleanroom gloves protect against chemicals?

A: Yes, certain types of cleanroom gloves offer chemical resistance. The level of protection depends on the glove material and the type of chemical involved.

Q: How do I properly dispose of used cleanroom gloves?

A: Used gloves should be disposed of in designated waste containers for biohazard or contaminated materials, following the facility's waste management protocols.

Q: Can cleanroom gloves be autoclaved?

A: Some cleanroom gloves can withstand autoclaving, but this depends on the material. It is important to check the manufacturer's guidelines before attempting to autoclave gloves.

Q: Are there any special considerations for glove usage in a cleanroom?

A: Yes, users must ensure they change gloves regularly, avoid touching their face or body with gloved hands, and follow strict hand hygiene procedures before donning gloves.

Q: How do I know if cleanroom gloves meet industry standards?

A: Look for certifications from organizations like ISO (International Organization for Standardization) or ASTM (American Society for Testing and Materials) that indicate the gloves meet the required standards for cleanroom use.

Q: What is the difference between cleanroom gloves and regular exam gloves?

A: Cleanroom gloves are specifically designed for use in controlled environments with strict contamination standards, while regular exam gloves are generally used in medical settings for patient examination and are not always suitable for cleanroom applications due to higher particle and contamination levels.

Q: Why are gloves required in a clean room?

A: Workers in cleanrooms and laboratories wear single-use gloves to protect themselves, mainly against chemical and biological risks during handling, but also to protect their work and industrial processes.

Q: When should sterile gloves be worn?

A: When there is a likelihood of coming into direct contact with a patient's blood or other potentially infectious materials (e.g. body fluids, moist body substances and saliva [in dental procedures]), mucous membranes and nonintact skin.

Q: How long do sterile gloves stay sterile?

A: Natural rubber or latex gloves have three years lifespan or shelf life, while synthetic gloves like nitrile, neoprene, and vinyl can last five years in storage. However, you can use them even after ten years as long as they are stored properly and are not damaged or deteriorated.

Q: What are the principles of gloving?

A: When gloving, the surgeon's skin must only ever touch the inside of the gloves and never the outside. Conversely, the outer surface of a glove must only touch the outer surface of the other glove and not the inside. These rules ensure that sterility is maintained.

Q: Do you need to wash your hands before putting on sterile gloves?

A: Gloves are not a substitute for hand hygiene. If your task requires gloves, perform hand hygiene prior to donning gloves, before touching the patient or the patient environment. Perform hand hygiene immediately after removing gloves.

Q: What are cleanroom gloves made of?

A: Cleanroom gloves are commonly made from materials such as natural rubber latex, nitrile, neoprene, vinyl, or TPE (Thermoplastic Elastomer) to provide a barrier against contaminants while minimizing particle shedding.

Q: Why are cleanroom gloves important?

A: They are crucial for maintaining the integrity of the clean environment by preventing hand-born contaminants from coming into contact with sensitive products, processes, and surfaces within cleanrooms.

Q: What are the different levels of cleanroom gloves?

A: Cleanroom gloves are categorized by their cleanliness level, typically ranging from ISO Class 5 to ISO Class 9, with ISO Class 5 being the cleanest. The appropriate glove level depends on the cleanliness requirements of the specific cleanroom environment.

Q: Are all cleanroom gloves powder-free?

A: No, but many are powder-free to reduce the risk of particle contamination. Some users may prefer powdered gloves for better donning, but these are less common in cleanrooms due to the potential for particle release.

Q: How do I choose the right size of cleanroom gloves?

A: Choose gloves that fit snugly without restricting movement. Manufacturers often provide sizing charts to assist in selecting the correct size. Proper fit is essential to prevent glove slippage, which could lead to contamination.

Q: Can cleanroom gloves be reused?

A: Typically, cleanroom gloves are single-use items intended for one-time wear only. Reusing gloves increases the risk of contamination and compromises the cleanroom's standards.

Q: How should cleanroom gloves be stored?

A: Store gloves in a sealed, dry, and cool area away from direct sunlight and contaminants. Ensure they are kept in their original packaging until use to maintain cleanliness.

Smartet Technology Development Co., Ltd. is known as one of the most professional cleanroom glove manufacturers and suppliers in China. Feel free to wholesale quality cleanroom glove in stock here from our factory. We also support customized service, welcome to check quotation with us.

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