Medical gloves are essential for protecting healthcare personnel, as they protect the wearer from exposure to illness, infection, and bodily fluids during examinations and medical procedures. However, not all gloves on the market are suitable for medical use. Medical facilities must ensure that they’re using medical-grade gloves, which are different from industrial, food service, and general-purpose gloves.
Here’s how to tell if your gloves are medical grade:
- Look for specific terminology in the product description.
- Choose an AQL rating of 2.5 or less.
- Check the FDA 510(K) premarket notification database.
- Determine the glove’s material.
- Consider the price.
Choosing the right gloves for your healthcare facility can make the environment safer, healthier, and more productive space. Consider several factors in your search to determine that the gloves are medical-grade. Read on to learn more.
1. Look for Certain Terminology in the Product Description
Before purchasing medical gloves, pay close attention to the product label and description.
The United States Food and Drug Administration (FDA) maintains stringent guidelines regarding the labeling of disposable gloves, particularly those used in medical examinations or surgical procedures. Manufacturers cannot use specific terminology on their packaging or marketing materials unless they meet particular criteria.
Safety is the biggest difference between medical, industrial, food, and general-purpose gloves. Medical-grade gloves are the safest of all disposable gloves, as they’re subjected to (and must pass) multiple safety and efficacy tests.
Manufacturers often label tested, medical-grade gloves with one or more of the following words or phrases, according to the FDA’s Medical Glove Guidance Manual:
- For Medical Use
- Medical Examination Gloves
- Patient Examination Gloves
Industrial, food, and general-purpose gloves cannot be legally used for any of the terminologies mentioned above on their labels. Therefore, when shopping online for medical-grade gloves, always read the product description. If possible, zoom in on any product images to read the packaging.
Additionally, look for labeling regarding the intended use of the gloves. A few examples of the types of medical-grade gloves available include:
- Surgical Gloves. Surgical gloves require sterilization — there are no FDA-approved, non-sterile surgeon gloves available. When surgical glove manufacturers submit the product to the FDA, they must also provide information on sterilizing the gloves. Therefore, if the gloves say “non-sterile,” they’re not suitable for sterile use. However, not all medical-grade gloves are sterilized.
- Microsurgery Gloves. Like surgical gloves, microsurgery gloves must be sterilized. The difference between microsurgical and surgical gloves is thickness. Microsurgical gloves have thinner material at the fingertips. However, they undergo the exact testing requirements as surgical gloves.
- Orthopedic Surgical Gloves. These gloves are thicker than surgical gloves but undergo all of the same rigorous testing. The FDA doesn’t allow any surgical gloves to use terms such as “extra thick” or “extra strong.” Instead, they recommend listing the exact thickness of the glove using millimeters.
- Chemotherapy Gloves. Gloves used during chemotherapy must meet all medical-grade requirements and undergo testing for permeation and penetration. In addition, chemotherapy gloves are tested against actual chemotherapeutic treatments to determine their safety and effectiveness.
- Radiation Surgical Gloves. Surgeons who complete surgical procedures utilizing radiation require radiation surgeon gloves. These gloves offer protection from radiation exposure, as well as transmissible illness. Radiation surgical gloves must meet all testing requirements of surgical gloves and must also protect against the energy range of x-rays used in medical procedures.
Sterile vs. Non-Sterile Medical Gloves
When looking for medical-grade surgical gloves, you must purchase sterile equipment. Gloves labeled “sterile” are even safer than patient exam gloves in terms of contamination.
As mentioned above, there are no safe non-sterile surgical gloves on the market. All surgical gloves must have a sterile rating. The medical gloves must meet stringent FDA and ASTM guidelines to achieve this rating.
Not only do surgical gloves require an acceptable quality level (AQL) of 1.5 or lower (we’ll discuss AQL in-depth later on), but sterilization procedures must be submitted to the FDA.
Thickness and Tensile Strength
In addition to tests regarding permeability and penetration, medical-grade gloves undergo testing on thickness and strength. Occasionally, manufacturers list the glove’s thickness or tensile strength on the packaging. However, this isn’t a legal requirement.
A higher tensile strength rating indicates better durability and tear resistance. Since abrasions, tears, and punctures compromise a glove’s protective barrier, tensile strength is critical when choosing medical-grade gloves.
The two most tear-resistant disposable glove materials include nitrile and latex. Most healthcare facilities consider nitrile the best, as it provides excellent touch sensitivity, durability and does not cause reactions in latex-sensitive persons.
Other Non-Medical-Grade Gloves
The FDA does not regulate all disposable gloves. Any gloves not regulated by the FDA cannot be approved for medical use and, therefore, aren’t medical-grade. When looking for medical-grade gloves, beware of gloves with the following labeling.
- Embalming Gloves. These gloves are not regulated by the FDA, but by the Occupational Safety and Health Administration, due to the use of formaldehyde in embalming procedures. Embalming gloves aren’t considered “medical-grade.”
- Food Service Gloves. Food-safe gloves are regulated by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), but the standards are lower than those used on medical gloves. These aren’t subjected to premarket review, nor are they stringently tested for safety and effectiveness. Therefore, these gloves aren’t medical-grade.
- Cleaning Gloves – The FDA doesn’t regulate disposable gloves for janitorial use. Suppose a janitorial job requires cleaning or handling items or surfaces that have come in contact with bio-hazardous material, such as bodily fluids. In that case, medical-grade examination gloves should be used. Cleaning gloves aren’t recognized as medical-grade.
- Industrial or General-Purpose Gloves – Gloves used for tasks other than contact with patients or bio-hazardous material are considered “general-purpose,” and those used in labor are considered “industrial.” The FDA does not regulate these types of gloves as medical devices, and it’s illegal to market industrial or general-purpose gloves for medical use.
2. Choose an AQL Rating of 2.5 or Less
The acceptable quality level or AQL of disposable gloves determines how many defective gloves are “acceptable” in a single batch during quality control inspections.
All medical-grade gloves must have an AQL of 2.5 or less. This means that 2.5 or fewer gloves in a batch of 100 may be defective. If more than 2.5 out of 100 are defective, the batch doesn’t qualify as medical-grade. Surgical gloves, however, require an AQL of 1.5 or lower.
In the cases of AQLs higher than 2.5, gloves are often marketed and sold as industrial-grade gloves instead. Industrial or general-purpose gloves may have an AQL as high as 4.
The AQL scoring system is critical when choosing medical-grade gloves. It ensures that gloves used in medical environments don’t have severe defects, such as tears, punctures, or other quality issues. This system protects healthcare professionals and patients from pathogens, contaminants, chemicals, and other hazardous substances.
When seeking out medical-grade gloves, check for an AQL rating. It’s often listed in the product description or printed directly on the packaging.
3. Check the FDA 510(K) Premarket Notification Database
For gloves to qualify as medical-grade, manufacturers must submit a 510(K) submission to the FDA. These submissions show the FDA that the products are safe, effective, and meet all guidelines set forth by the administration and the American Society for Testing and Materials (ASTM).
Each submission includes information regarding testing, such as puncture and abrasion resistance, tensile strength, substance permeability, and elongation tests to ensure they meet safety standards.
Consumers can search the FDA 510(k) Premarket Notification Database to locate 510(K) submissions using medical glove product codes. These submissions indicate that the product is equally compared to legally marketed medical devices and complies with all testing and guidelines.
You can use the following product codes to identify 510(K) submissions for medical gloves in the FDA database:
|Patient Examination Gloves|
|Name||FDA Product Code|
|Polymer (includes Nitrile, Polyurethane, etc.)||LZA|
|Speciality: Chemotherapy, Radiation, etc.||LZC|
FDA-Approved Gloves vs. FDA-Accepted Gloves
It’s important to note that FDA-accepted and FDA-approved aren’t the same thing.
In the case of FDA-approved medical gloves, the “approval” terminology indicates that the gloves have passed all testing and meet all guidelines to ensure that defective products are unlikely to make their way to hospitals, clinics, and other healthcare facilities.
If a product fails the testing for the medical-grade approval, it may still be accepted for industrial or general-purpose applications. When the FDA accepts a product, such as a glove used for industrial applications, it means that the product’s effectiveness is acceptable for its intended use — it failed quality tests for medical-grade standards but is still safe for use in other settings.
4. Determine the Glove’s Material
Medical-grade exam gloves come in three different materials, including:
Gloves not made from one of the above materials aren’t medical-grade. With that said, there are some tested, medical-grade nitrile/vinyl blends available.
Let’s look at these materials a little more in-depth:
- Latex – Made with natural latex rubber, latex provides a thin, protective barrier while allowing the wearer to retain both dexterity and touch sensitivity. However, according to OSHA, 8 to 12 percent of people working in the healthcare industry experience latex sensitivity. As such, most experts recommend using latex alternatives.
- Nitrile – Commonly used in healthcare settings, nitrile offers excellent protection and strength. The material easily molds to the hand and is relatively affordable. Nitrile is stronger than latex in terms of puncture resistance and provides a high level of touch sensitivity. In addition, nitrile does not use the proteins found in latex, so it’s a suitable alternative for latex-sensitive persons.
- Vinyl – Derived from polyvinyl chloride (PVC) and chemicals called plasticizers, vinyl gloves are the least expensive disposable gloves — but they’re not as strong. Vinyl has a susceptibility to tears, punctures, and abrasions, increasing the risk of contamination. Additionally, they don’t “mold” to the hand’s shape, thus reducing the dexterity of the wearer, which could further increase the risk of contaminant exposure.
For medical-grade gloves, nitrile is the favorite. Its strength, durability, touch sensitivity, affordability, and resistance make it the best option for medical-grade gloves.
Latex Gloves and Allergies
In 2014, the FDA modified its guidelines for labeling latex exam gloves. Prior to the change, manufacturers often marketed products as “latex-free.” However, there are no accepted testing procedures in place to determine whether a product contains no rubber latex proteins. As such, the phrase “latex-free” is factually incorrect and therefore misleading.
The FDA noted that manufacturers wishing to indicate that natural latex rubber was not used in the manufacturing process may state “not made with rubber latex.” They can’t, however, continue using “latex-free” or “made without latex” on their products.
With that said, if you come across a product that claims the medical-grade label but also says “latex-free,” the company isn’t aligning with FDA guidelines. Therefore, it’s safe to assume that they’re also not compliant with the FDA’s strict testing requirements either.
Another important thing to watch out for when purchasing medical gloves is powder. All medical-grade gloves should be powder-free.
Powdered medical gloves are no longer used in healthcare settings due to an FDA ban in 2017. After review, the administration determined that powdered gloves increase the risk of injury, illness, and allergic reactions. They may cause airway inflammation, granulomas, or other health risks. Therefore, powdered gloves should no longer be used for surgical or examination purposes, and cannot be labeled as medical-grade.
4. Consider the Price
Generally speaking, products that achieve the medical-grade rating cost more — this is because the strict testing requirements cost the manufacturer, too. Additionally, better materials are used in the production of medical-grade gloves.
Medical-grade gloves provide far more benefits than non-exam gloves, including (but not limited to):
- Protection from a plethora of substances, including chemicals, infectious agents, biohazardous material, and other dangerous contaminants
- More dexterity and touch sensitivity than non-exam gloves
- Increased grip (some medical-grade gloves even offer textured fingertips)
Due to the many benefits, paying extra for medical-grade gloves is worth it. The saying, “you get what you pay for,” applies in this scenario. It’s unlikely that cheap gloves are medical-grade. In fact, if you find cheap gloves labeled as “medical-grade,” do your research to ensure that what you’re getting is an authentic product or a cheap import.
Cheap imports typically do not undergo the rigorous testing required in the United States. By purchasing these products, you could end up receiving defective products. This is dangerous, as it increases the risk of contamination, exposure, and the spread of bacteria and viruses.
Only purchase medical-grade gloves from reputable suppliers. If you discover that you’ve purchased fraudulent medical gloves, submit a report to the FDA.
Medical-grade gloves are a critical investment that healthcare facilities must make to ensure proper protection. When looking for medical-grade gloves, remember to do the following:
- Look for the terms “exam,” “for medical use,” “medical examination gloves,” or “patient examination gloves.”
- Choose gloves with an AQL rating of 2.5 or lower for patient exam gloves, and 1.5 or lower for surgical gloves.
- Identify FDA-cleared medical gloves using the FDA 510(K) database.
- Use only powder-free gloves.
- Consider paying more for quality medical-grade gloves.
Choosing the right gloves for your facility ensures a safe, healthy environment. Here at Allied USA, we’ve made it a priority to provide a wide variety of medical-grade gloves. It’s easier than ever to find exactly what you’re looking for. Browse our selection today!
- United States Food and Drug Administration: Medical Glove Guidance Manual
- United States Food and Drug Administration: Guidance for Industry and Staff (PDF)
- American Society for Testing and Materials: Standard Specification for Rubber Surgical Gloves
- UC Berkeley: Glove Selection Guide
- Occupational Safety and Health Administration: Formaldehyde
- United States Food and Drug Administration: Center for Food Safety and Applied Nutrition (CFSAN)
- Quality Inspection: What is the AQL?
- United States Food and Drug Administration: 510(K) Premarket Notification Database
- Occupational Safety and Health Administration: Latex Allergy
- United States Food and Drug Administration: Don’t Be Misled by “Latex-Free” Claims
- Federal Register: Banned Devices; Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove
- United States Food and Drug Administration: Import Alert 80-04
- United States Food and Drug Administration: How To Report Product Problems and Complaints to the FDA