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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 guide is to outline everything you and your workers need to know about disposable nitrile gloves. This includes:
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 and approximately 1 in 2 people with latex allergies have a history of another type of allergy.
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 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 and 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 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 and 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:
Class I: These devices are 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 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?
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, are popular today is, in large part, due to the first and second 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, during 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 new and cheaper synthetic rubber that meet 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.
Click here to read more about the history of synthetic rubber by Bio-Materials expert, Doris de Guzman.
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:
Once the synthetic materials have been created, they are sent to the factory for production:
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.
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.
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:
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 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.
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.
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:
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.
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 should contaminate 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.
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.
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.
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.
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.
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.
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.
The price of nitrile gloves – or any disposable glove for that matter depends largely on the availability of the raw materials.
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 like car tires.
If the facilities that manufacturing butadiene shut down for extended periods of time, then the price of nitrile will begin to increase as well.
The availability of natural latex rubber will also play a role in the price of nitrile. 40 percent of the world’s natural rubber resources come from Thailand. In recent years, Thailand has experienced weeks of unseasonal flooding. This results in poor crops and affects the amount of latex rubber that is available on the market. Causing demand, and price, of nitrile to skyrocket.
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:
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.
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.
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.
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.
As we covered in the section of glove color coding many industries have specific glove colors that are required. Review the color requirements in your workplace for gloves.
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.
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.
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.
In 2015, the Bureau of Labor Statistics reported 124,450 hand injuries, among them:
These are injuries that could largely have been prevented with the correct usage and disposal of disposable nitrile gloves.
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