Whether you work in medicine, food processing, automotive or body art, disposable gloves are necessary. But because they’re single-use, wearers don’t think too hard about the glove’s composition.
The goal of this Ultimate Guide is to outline everything you need to know about disposable nitrile gloves, including:
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What is nitrile
Medical and industrial-grade disposable gloves: What’s the difference?
A brief history of nitrile
How are nitrile gloves made?
Thicknesses of disposable nitrile glove: Advantages and disadvantages
Disposable gloves in the food industry
Powder or powder-free gloves
How to properly remove a disposable glove
The price of nitrile gloves — Compared to latex and vinyl
Steps to choose the right nitrile gloves
What is Nitrile?
Nitrile is quickly becoming the material of choice for single-use gloves.
The main reason is because unlike latex, which is a natural rubber, nitrile is synthetic and does not cause allergic reactions.
There are 3 million people (1 percent) in the United States that have allergies to natural rubber latex. However, this percent grows among those who have regular exposure to latex products, like disposable latex gloves.
According to the American Latex Allergy Association between 8 and 17% of healthcare workers report allergies to latex. Approximately 1 in 2 people with latex allergies have a history of another type of allergy.
Medical and Industrial-Grade Disposable Gloves: What’s the Difference?
Choosing the proper disposable nitrile glove depends on the application.
The two main categories of nitrile gloves are industrial and medical grade. This section of the guide will expand on those two glove grades.
Industrial Grade:
Industrial-grade nitrile gloves are best suited for applications that involve handling harsh chemicals and solvents.
Industries that would use this grade of nitrile glove include:
- Automotive
- Janitorial
- Food Services
Along with chemical resistance, an important feature of industrial-grade gloves is a high level of puncture resistance.
While industries like food services have specific requirements that gloves need to meet, they are not as stringent as medical-grade gloves.
Medical Grade:
Medical gloves are used in areas where there’s a risk of contact with blood-borne pathogens or environmental contaminants.
Also known as examiner gloves, medical gloves are used in:
- Hospitals
- Laboratories
- Cleanrooms
- Dental Offices
Since the risks are so high, medical grade gloves must be rigorously tested and have to meet specific guidelines from the Food and Drug Administration (FDA).
To read the full document “Guidance for Industry and FDA Staff: Medical Glove Guidance Manual” click here.
Medical-grade gloves, like any medical device, are regulated in the United States by the FDA, which has authority to regulate medical devices before and after they reach the marketplace.
Medical devices can be anything from dental floss to heart valves.
Here are the three different classes of medical-grade gloves:
Class I:
These devices that considered to be low risk and have the least regulatory controls.
Class II:
These devices have a higher risk than Class I and have greater regulatory controls to ensure the device’s safety and effectiveness.
Class III:
These are the highest risk devices and have the highest level of regulatory control. Class III devices must typically be approved by FDA before they are marketed.
Read more about medical-grade disposable nitrile gloves in our blog Double-Gloving Are There Really Benefits to Wearing Two Gloves?
A Brief History of Nitrile:
Unlike latex which is a sap-like fluid that can be found in over 20,000 plants, nitrile is a petroleum by-product that is produced in a lab.
The major reason that synthetic rubbers like nitrile have become popular today is, in large part, due to the two World Wars.
A shortage of natural rubber during World War I encouraged Russian scientists to begin experimenting with synthetic rubber.
When the war came to an end in 1918 and natural rubber was once again available, demand for synthetic rubber diminished. However, in the following decades, German, American and Russian scientists continued to explore to possibilities and uses of synthetic rubber.
By 1940, a scientist at B.F. Goodrich Company developed a newer and cheaper synthetic rubber that met the United States’ needs during World War II. Since the Axis Power controlled much of the world’s supply of latex rubber by 1942, an alternative was needed.
Both sides once again began experimenting with synthetic rubber. In America, chemist Calvin Souther Fuller examined the elasticity and tensile strength of polymers.
By 1944, 50 factories were manufacturing synthetic rubber at twice the volume of the world’s natural rubber production prior to the war. In Nazi Germany, 8 plants were producing over 120,000 tons per year.
How are Nitrile Gloves Made?
Nitrile, also known as acrylonitrile butadiene rubber (NBR), is a copolymer that’s derived through the emulsion polymerization of butadiene and acrylonitrile. These molecules provide two specific advantages to nitrile gloves:
- Acrylonitrile improves chemical resistance
- Butadiene creates flexibility and tear resistance
Producing Disposable Nitrile Gloves:
Once the synthetic materials have been created, they are sent to the factory for production:
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Cleaning the Formers: The ceramic, hand-shaped formers are run through water and acid to clean them and remove residue. The formers are then dried to remove any remaining liquids.
Preparing the Formers: The formers are dipped in a mixture of calcium carbonate and calcium nitrate to help the nitrile to solidify around the formers. The formers are then dried again.
Dipping in Nitrile: The formers are dipped into a tank of NBR compound, which may include other additives and colors.
Vulcanizing Nitrile Rubber: The NBR coating must be heated at a high temperature to form the gloves as they dry.
Leaching the Gloves: Gloves are then dipped in water tanks to remove all residues and extractable chemicals. This is crucial for medical and food-grade gloves.
Beading the Cuffs: Once leaching is compete, the cuffs are rolled to make the glove easier to remove and less likely to tear near the wrist. Gloves may undergo leaching again after beading.
Finishing Process: At this point, gloves are treated to be easier to don. Traditionally, glove manufacturers used powders. These days, they are moving away from powdered gloves, which will be explored in the powder section. To create a glove for easier donning, nitrile gloves undergo one of two processes:
- Chlorination: This involves exposing the gloves to chlorine to make the material harder and slicker.
- Polymer coating: This lubricates the glove surface by adding a layer of polymer.
Stripping Phase: This is the final stage of production. Once the gloves are finished, workers remove them from the formers by hand.
At this point, gloves must be checked for quality control issues. Particular attention is given to making sure that there are no holes or snags in the material.
Gloves will go through rigorous testing to ensure that they will not be faulty or lead to contamination for glove users.
The Pinhole Leak Test:
One test based on standards from the American Society for Testing and Materials (ASTM) and regulated by the U.S. Food and Drug Administration (FDA) is the pinhole leak test.
A selection of gloves are filled with water and hung upside down for two minutes to see they can hold the water.
These tests adhere to acceptable quality limits (AQLs), which are percentages indicating how many gloves in a batch can fail the test to determine if the entire batch fails. If the nitrile gloves pass these quality assurance tests, they are then packed in boxes and shipped
“pinhole leak test”
Thicknesses of Disposable Nitrile Gloves: Advantages and Disadvantages
The thickness of disposable gloves is measured in mils. A mil equals one-thousandth of an inch (0.001 inch).
Disposable nitrile gloves can be as thick as 8 to 15 mils, but general purpose nitrile gloves are typically four mils thick.
For comparison, a dime is 35 mils and a plastic grocery bag is around 3 mils thick.
Achieving the desired thickness for a disposable glove depends on:
- Dwell time
- Pretreatment concentration
- Nitrile viscosity
The more viscous the NBR compound is during the dipping phase, the thicker the disposable nitrile glove will be.
These thicker disposable gloves will be used for specific purposes.
Tattoo artists prefer to use 8 mil nitrile gloves because they have a good balance between puncture protection and touch sensitivity.
In more industrial applications, thicker gloves are beneficial to act like a thicker barrier of protection from harsh environments.
Thicker nitrile gloves provide longer permeation timeframe when working with chemicals.
Tensile Strength:
Tensile strength is a material’s ability to resist tension when being pulled apart. It’s measured by the greatest stress a material can withstand when stretched without breaking. The industry standard for tensile strength of disposable gloves is 14 megaPascal (MPa).
A glove’s thickness used to have a direct correlation to its tensile strength. But with innovation and technological advancement, thinner gloves are reaching the same tensile strength as thicker gloves.
As a glove user, you shouldn’t buy gloves with less than a tensile strength of 14 mPa or else quality will suffer and glove usage rates will increase.
Disposable Gloves in the Food Industry:
Approximately 20 million Americans get sick from norovirus each year. The number one cause for norovirus outbreaks in the US is contaminated foods – 54% of which involved food workers touching ready-to-eat foods with their bare hands.
According to the FDA 2013 Food Code, single-use gloves can only be used for one task. I.e. working with ready-to-eat food or with raw animal food but not both. These gloves must also be disposed of when damaged or soiled or if there was interruptions that happened during operation, like a shutdown. Read more about proper disposal of gloves in the section on properly removing gloves.
Food-Grade Glove Regulations:
Country specific regulations:
If your business is based in the United States or operating in the country, you must adhere to regulations from the Code of Federal Regulations Title 21. The section pertaining to disposable gloves is under indirect food additives, which are substances that may come into contact with food as part of packaging or processing equipment but aren’t intended to be added directly to food.
The government body addresses uses for indirect food additives as:
- Adhesives and components of coatings
- Polymers
If your business is based in the European Union, you’ll need to follow the framework Regulation (EC) No. 1935/2004, which applies to all food contact materials. Countries within the European Union may have more stringent requirements for disposable gloves.
For instance, in Germany, food contact legislations for rubbers is outlined in “Commodities based on Natural and Synthetic Rubbers,” which outlines four categories of use, ranging from several months (storage containers) to rubber articles that come into contact with foods for under ten minutes.
For businesses based in Canada or operating in the country, you must follow the Canadian Food Inspection Agency’s Guide to Food Safety.
Regardless of the country, manufacturers should be able to produce documentation that the glove has passed your countries specific standards.
Hazard Analysis and Critical Control Points & Glove Color Coding:
One method to eliminate food contamination is to use hazard analysis and critical control points (HACCP), which is a systematic preventative approach to food safety. The goal of HACCP is to avoid hazards rather than attempting to inspect finished products.
One of the simplest and most effective HACCP compliance methods is to color code gloves.
It can be particularly helpful if you’re concerned with pathogens, allergens and other foreign contaminants with your operations.
If workers don’t change gloves between tasks, there is risk of transferring microorganisms. For example, if a worker is handling raw meat and then works with cooked meat, harmful bacteria can be transferred to the finished product.
Different colors can be assigned to each step in the process or by manufacturing lines. For example:
- Green gloves could be assigned to facilities and processing lines that handle processed or cooked meats.
- Red may be assigned to those handling raw meat.
- Blue colored gloves are widely used in poultry and other food processing industries because blue is a detectable color.
If glove particles contaminates a product, it’s easy to identify because it’s a color not generally found in foods.
By assigning colors to each step it becomes easier to determine if a glove has been misplaced or if someone is working in the incorrect area. This level of traceability can translate to the prevention of costly recalls and deadly illnesses.
Other Disposable Glove Color Choices:
Black is a popular choice with mechanical, industrial, automotive, and various trades because it hides dirt, grease and grip to help maintain a professional look. Tattoo artists also prefer black because it does not show ink stains or blood and keeps their clients from worrying when they look down.
Glove Composition:
The preferred glove composition is based on the application, according to foodqualityandsafety.com. Polyethylene or vinyl gloves are rarely used because of phthalates. Latex gloves could be used for intermediate situations, but due to the popularity of nitrile gloves over latex, nitrile is the glove of choice for intermediate to long-term use in food processing.
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Nitrile is considered the glove of choice for the food industry because it avoids the issue of allergies associated with latex and is resistant to many of the same chemicals as latex.
No matter the glove composition, disposable gloves used in the food industry must be powder-free for fear of contamination. Powdered gloves are also no permitted in medical examination gloves. This ban will be discussed further in the next section.
Powder or Powder-Free Gloves:
Effective January 18, 2017 the Food and Drug Administration (FDA) banned the use and sale of powdered surgical and patient examination gloves in the United States.
The ban was initially proposed in March 2016, when the FDA suggested a ban on most powdered medical gloves, prohibiting the marketing and sale of powered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating surgeon gloves.
In the final decision, it was rules that the risks of illness and injury associated with glove powder outweighed its benefits to the user, which is primarily the ease of donning and doffing gloves.
The ban applies to gloves that “are already in commercial distribution and for these devices that are already sold to the ultimate user, such as small medical practices and hospitals,” according to the FDA’s website.
To learn more information about the ban and history of this movement, read our article ‘FDA Bans Powdered Medical Gloves – Now What’
While the FDA has not banned powdered disposable gloves for industrial purposes, their use has been widely discontinued.
Powder-free disposable gloves are cleaner, won’t cause contamination and are only marginally more expensive than a powdered disposable glove.
Powder-Free Gloves:
As part of the FDAs ban on powdered gloves, they disagreed with the assertion that “non-powdered gloves have a higher propensity to tear and thus that use of non-powdered gloves presents a greater risk of contamination, post-procedure infections, or exposure of the user to blood.”
The FDA ban also found that nitrile gloves “offer the same level of protection, dexterity, and performances as [natural rubber latex] gloves.”
Chlorination is the most common alternative to making a powderless glove that slips on easily. During the finishing stage, manufacturers wash gloves in a chlorine gas or a solution of hypochlorite and hydrochloric acid. Gloves are then rinsed to prevent the chemical from interacting with the glove any further. The solution reduces the surface ‘tackiness’ of the glove and gives it a softer texture.
Polymer coating: Manufacturers use polymers like silicones, acrylics and hydrogels. Because the polymer coating has less surface friction than the glove material, it slips on the hand easier. The polymer is usually applied while the glove is still on the former.
How to Properly Remove a Disposable Glove:
The point of disposable gloves in most industries is to serve as a barrier between your skin and potentially harmful substances. That’s why they are single-use items. They can be used, removed and thrown away without worrying about contamination.
However, the way that your gloves are taken off after being used plays a big part in making sure that contamination does not spread.
Putting your gloves on properly takes a bit of care to make sure that the material does not stretch too much. This can cause small tears that leave your skin vulnerable.
But taking your gloves off – also called ‘doffing’ – is a vital part in keeping you safe. This section looks at the proper way to remove disposable gloves.
Side note: It’s probably a smart idea to practice doffing disposable gloves that aren’t contaminated. That way, if it takes a few tries to get it right, you won’t have to worry about what your bare skin may have come into contact with.
Here is the step-by-step method:
- Pinch the outside of the glove about an inch or two down from the top edge inside the wrist.
- Peel downwards, away from the wrist, turning the glove inside out
- Pull the glove away until it’s removed from the hand. Hold the inside-out glove with the gloved hand.
- With your gloveless hand, slide your fingers under the wrist of the glove, do not touch the outside surface of the glove.
- Repeat step 3. Peel downwards, away from the wrist, turning the glove inside out.
- Continue pulling the glove down and over the first glove. This ensures that both gloves are inside out, one glove enveloped inside the other, with no contaminants on the bare hands.
- Dispose of the gloves in a proper bin- this may differ depending on company policies.
The Price of Nitrile Gloves:
The Raw Material:
The price of nitrile gloves – or any disposable glove for that matter depends largely on the availability of the raw materials & Certification
As this piece covered under the section how nitrile gloves are made, one of the key ingredients to the creation of nitrile gloves is butadiene.
Supply and demand will always play a price in the cost of gloves. Butadiene, one of the key ingredients in making nitrile, is in high demand due to increased manufacturing of items If the facilities that manufacturing butadiene shut down for extended periods of time, then the price of nitrile will begin to increase as well.
Nitrile Compared to Latex & Vinyl:
Setting aside the economics of supply and demand, these three materials will range in prices.
Factors that will increase the price of gloves, regardless of material:
- Thickness: The more material that is used, the more you can expect to pay
- Powder-Free: As discussed in the section of powdered gloves, one of the most attractive aspects about powdered gloves was their cost effectiveness. Engineering a glove that will easily don and doff without powder will cost more.
- Additives: Some gloves will include Vitamin E or Lanolin to moisturize your hands while you’re wearing them.
That being said, if you took a vinyl, nitrile and latex glove that were all powder-free, of the same thickness and additive free, you could still expect to pay different prices.
- Vinyl: Vinyl is the least expensive material for producing disposable gloves
- Latex: Latex is approximately 80 percent more expensive than vinyl
- Nitrile: Nitrile is double the price of vinyl and roughly 15 percent more expensive than latex
Why is Nitrile Expensive?
Economic factors like supply and demand aside, nitrile is the most expensive because it is a good alternative to latex. This has become more important in recent years with the rise of latex allergies and sensitive skin. Nitrile is also more appealing because it is the most chemical-resistant of the three fabrics. Meaning that it can be worn by more people who are doing more applications.
How to Choose the Right Nitrile Gloves:
Now that you have more information than you ever thought you could want about nitrile gloves, it comes to the decision of selecting the correct disposable nitrile gloves for your application. Considering these variables should be stressful – disposable gloves won’t have as many variables as gloves designed for cut or impact resistance.
Step 1: Glove Selection
Glove Thickness
The rule of thumb when choosing disposable gloves is the thicker the glove in mils the less dexterity you will have.
The difference between a 3 mil thick glove and an 8 mil thick glove is 5/1000th of an inch. It may not seem like much difference, but for someone working in food processing for eight hours a day, selecting the thinner gloves means less sweaty, tired hand.
On the other end, tattoo artists or painters and finishers need thicker gloves because there’s more puncture threats and wear and tear associated with their jobs.
Glove Color
As we covered in the section of glove color coding anchor tag to glove color coding section many industries have specific glove colors that are required. Review the color requirements in your workplace for gloves.
Fit
Finding the right fitting glove is as crucial as choosing the right thickness of glove. Too small and the glove will tear, too big and the glove will be awkward to work in and may slip off. A quality glove manufacturer will be able to provide gloves in sizes, at minimum, small to extra-large.
Step 2: Wear Trials
Once you have decided on the correct thickness and color of nitrile disposable gloves for your workplace, the next step is to narrow down your options. Choose gloves that meet your criteria from a variety of manufacturers.
After choosing three or four different glove options, gather a team of people to trial the gloves. The team should include workers of different sizes and genders to allow for multiple viewpoints.
Throughout the day, the employees should write down feedback about the gloves and any points of concern. Did one glove rip at the wrist when donning or did another glove have noticeably better grip? These employees should also make a point of writing down how long each glove lasted – this way a glove that lasted noticeably longer can be the clear front-runner, regardless of cost.
Be sure to have the same group involved in the wear trials for each of the gloves to ensure consistency.
Step 3: Review the Data
Once the wear trials are completed, it’s time for your organization’s safety manager and purchasing department to collect the forms and review the options. Generally the forms should give a clear indication of which glove performed the best. Pay special attention to the amount of time each glove was worn. If a more expensive glove is being worn for longer periods of time, it will reduce usage and, in turn, costs in the long run.
Source: https://t-tees.com
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