Types of Medical Gloves
Understanding the Different Grades of Medical Disposable Gloves:
Types, Uses, and Requirements
Medical disposable gloves are essential in various healthcare settings, providing protection against harmful substances, germs, and chemicals. These gloves come in different grades, designed to meet the specific needs of different tasks, from routine examinations to complex surgical procedures. Choosing the right glove grade is critical to ensuring safety and effectiveness for both healthcare providers and patients.
In this article, we will explore the different grades of medical disposable gloves, their characteristics, and the requirements for each. The three main types of gloves used in medical settings are examination gloves, surgical gloves, and chemotherapy gloves, each with distinct performance standards. Let’s take a closer look at these categories and what sets them apart.
Medical disposable gloves are categorized into three primary grades based on their intended use and the level of protection they offer. These are:
•Examination Gloves. • Surgical Gloves. • Chemotherapy Gloves
Each grade has specific requirements set by regulatory bodies such as the Food and Drug Administration (FDA), the American Society for Testing and Materials (ASTM), and the International Organization for Standardization (ISO). The gloves must meet specific criteria for barrier protection, durability, and biocompatibility to be approved for medical use.
Basic Materials Review
Latex Gloves
- Material: Made from natural rubber latex, offering excellent elasticity and comfort.
- Advantages: Superior fit, tactile sensitivity, and protection against bloodborne pathogens.
- Disadvantages: Potential to cause allergic reactions in some individuals.
Nitrile Gloves
- Material: Made from synthetic rubber, nitrile gloves are latex-free.
- Advantages: High resistance to punctures, chemicals, and pathogens. Suitable for people with latex allergies.
- Disadvantages: Slightly less tactile sensitivity compared to latex.
Vinyl Gloves
- Material: Made from polyvinyl chloride (PVC), vinyl gloves are less elastic than latex and nitrile.
- Advantages: Inexpensive, good for short-term tasks, and safe for people with latex allergies.
- Disadvantages: Less durable and prone to tearing, making them unsuitable for high-risk procedures.
Grades of Medical Disposable Gloves
Examination Gloves
Purpose: Examination gloves are used during non-invasive medical procedures such as patient examinations, diagnostic tests, and routine medical care. They protect healthcare workers from potential contamination and cross-infection.
Key Features:
- Single-use, disposable.
- Available in both sterile and non-sterile forms.
- Can be made from latex, nitrile, or vinyl.
- Ambidextrous (fits both hands).
- Designed for a comfortable fit and reasonable dexterity, but not as form-fitting as surgical gloves.
Requirements:
- FDA Approval: Examination gloves must meet the FDA’s standards for medical devices. The gloves are classified as Class I medical devices, which means they must be made under stringent quality control conditions to ensure safety and effectiveness.
- ASTM Standards: Examination gloves must meet ASTM D6319 (for nitrile gloves), ASTM D3578 (for latex gloves), or ASTM D5250 (for vinyl gloves). These standards specify the physical properties of the gloves, including their tensile strength, elasticity, and resistance to punctures.
- Barrier Protection: Examination gloves must pass tests for barrier protection, including resistance to penetration by viruses and bacteria. The gloves are tested using methods such as the ASTM F1671 viral penetration test to ensure that they can protect against bloodborne pathogens.
- Biocompatibility: The materials used in examination gloves must not cause skin irritation or allergic reactions, as per ISO 10993-10, which evaluates the skin sensitization and irritation potential of medical gloves.
Common Uses:
- Patient exams.
- Blood sample collection.
- Handling bodily fluids.
- Routine medical procedures.
Surgical Gloves
Purpose: Surgical gloves are used during invasive procedures, such as surgeries, to protect both the healthcare provider and the patient from infection. These gloves are held to a higher standard than examination gloves due to the critical nature of surgical procedures.
Key Features:
- Sterile and packaged individually.
- Anatomically shaped (right- and left-handed) for a more precise fit.
- Available in various thickness levels for enhanced protection.
- Made from latex or nitrile (sometimes sterile vinyl is used for certain cases).
- Designed for maximum dexterity and tactile sensitivity.
Requirements:
- FDA Approval: Like examination gloves, surgical gloves are regulated by the FDA and classified as Class II medical devices, requiring more rigorous testing and manufacturing standards due to their critical role in surgeries.
- ASTM Standards: Surgical gloves must meet ASTM D3577 (for latex gloves) or ASTM D6977 (for synthetic surgical gloves). These standards specify stringent requirements for the gloves’ tensile strength, elongation, and thickness to ensure they can withstand the rigors of surgical use.
- Sterility: Surgical gloves must be sterile to prevent infections during invasive procedures. They undergo sterilization processes such as ethylene oxide gas or gamma radiation, and their sterility must be validated according to ISO 11137 standards.
- Barrier Protection: Surgical gloves must provide superior barrier protection, as tested through the ASTM F1671 viral penetration test and puncture resistance testing to ensure protection against pathogens.
- Biocompatibility: Surgical gloves must meet biocompatibility standards as per ISO 10993-1, which ensures that the gloves are safe for prolonged contact with skin and sensitive tissues.
Common Uses:
- All types of surgeries, from minor to major procedures.
- Invasive medical procedures requiring sterility.
- Handling sterile instruments and materials.
Chemotherapy Gloves
Purpose: Chemotherapy gloves are specially designed to handle chemotherapy drugs, which can be toxic and harmful to both patients and healthcare workers. These gloves provide the highest level of chemical protection to prevent exposure to cytotoxic agents.
Key Features:
- Highly resistant to chemicals and punctures.
- Usually made from nitrile or neoprene (synthetic rubber).
- Thicker than standard examination or surgical gloves for added protection.
- Designed to maintain dexterity despite the thicker material.
Requirements:
- FDA Approval: Chemotherapy gloves are regulated as Class II medical devices due to their role in handling dangerous drugs. The FDA requires specific testing for resistance to chemotherapy drugs.
- ASTM Standards: Chemotherapy gloves must meet ASTM D6978 standards, which outline the testing methods for evaluating gloves’ resistance to chemotherapy drugs. This involves exposing the gloves to various cytotoxic agents and measuring any permeation or degradation.
- Barrier Protection: Chemotherapy gloves undergo stringent testing to ensure that no drugs can permeate the glove material, which could cause serious health risks. The gloves must resist not only penetration by liquids but also the degradation caused by prolonged exposure to chemical agents.
- Biocompatibility: As with other medical gloves, chemotherapy gloves must pass biocompatibility tests to ensure they do not cause irritation or allergic reactions, per ISO 10993-10.
Common Uses:
- Handling and administering chemotherapy drugs.
- Working in oncology departments.
- Preparing cytotoxic medications in pharmacies.
Other Considerations for Medical Disposable Gloves
In addition to the specific grades, there are several other important factors to consider when choosing the right medical disposable gloves:
Powdered vs. Powder-Free Gloves
- Powdered Gloves: Historically, powdered gloves were used to make it easier to put on and remove gloves. However, the powder can cause allergic reactions and complications during surgeries, leading to a ban on powdered medical gloves by the FDA in 2017.
- Powder-Free Gloves: Powder-free gloves are now the standard in healthcare settings. These gloves undergo special treatment to ensure they can be easily donned without the need for powder.
Allergies and Sensitivities
Latex allergies are a significant concern in healthcare. Many healthcare providers and patients are allergic to latex, which can cause skin irritation or more severe allergic reactions. As a result, nitrile and vinyl gloves are often preferred alternatives for people with latex sensitivities.
Glove Sizing
Ensuring the proper fit is essential for both safety and comfort. Gloves that are too tight can tear easily, while gloves that are too loose can reduce dexterity and make it difficult to perform tasks. Most gloves are available in sizes ranging from extra small (XS) to extra-large (XL).
Durability and Tactile Sensitivity
The durability of the glove depends on the material and the thickness. Thicker gloves provide better protection but may reduce tactile sensitivity, which is important for tasks requiring fine motor skills. Finding the right balance between protection and dexterity is crucial for different medical applications.
Conclusion
Medical disposable gloves come in various grades, each designed to meet specific requirements in healthcare settings. Examination gloves are ideal for routine tasks, surgical gloves provide enhanced protection for invasive procedures, and chemotherapy gloves are essential for handling hazardous drugs. Understanding the differences between these glove grades and the standards they must meet ensures that healthcare providers select the right gloves for the job, maximizing both safety and effectiveness.