Knowledge Base
Learn about infection control practices and considerations.
General
What type of testing is required for a medical glove to receive a 510(k) clearance?
A 510(k) is a premarket submission made to FDA to demonstrate that the medical glove to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed medical glove.
Medical gloves must be biologically compatible with human skin. To assess this, the FDA requires two biological tests:
- Primary skin irritation (PSI), which assesses the glove’s potential to produce dermal irritation.
- Dermal sensitisation, which determines the potential of a device to elicit a delayed hypersensitivity (Type IV) reaction.
Other data must also be submitted to confirm gloves meet or exceed minimum performance requirements described in the American Society for Testing and Materials (ASTM) standards. These include, but are not limited to:
- Physical dimensions (length, width and finger, palm and cuff thickness).
- Tensile strength and elongation (before and after aging).
- Freedom from holes.
- Powder levels.
- Total protein content (for natural rubber latex gloves).
Some of the additional tests required are dependent on the specific claims made on the gloves. For example:
- Chemotherapy Drugs andFentanylTestedClaim –Chemotherapy Drugs and Fentanyl Permeation test report.
- Low Dermatitis Potential Claim –Modified Draize-95 Test.
- Protein Labelling Claim –Protein Content test report with result < 50μg/g and Antigenic Protein result.
Is the weight of a glove automatically in relation to its quality?
The perceived high quality of a glove is often associated with higher weight, which is not necessarily true. Due to cost reduction most manufacturers use fillers which tend to be heavier than the polymers used in the glove. The moderate use of fillers is tolerable and can improve certain glove properties, whereas the excessive use of fillers can lead to a significant deterioration of glove performance characteristics. In addition, further factors affecting glove quality include the quality of raw materials used, specific formulations, manufacturing process and quality inspection system.
How do I ensure my medical examination gloves fit properly?
Choosing the proper size is paramount when ensuring a good fit for your medical examination gloves. Unfortunately picking the size of glove is somewhat of a trial and error process. For example, in general you might find you are a medium (or a small, or large etc.). The feel and fit of a glove changes slightly depending on specific glove lines and the thickness of the material. As such, when trying on an exam glove ask yourself the following questions.
- Is the glove too tight?
Does your examination glove fatigue your hand? Do you feel resistance when you move your fingers? If so, consider a larger glove. In addition to being more comfortable, a larger glove will be less susceptible to over-stretching, which may reduce the risk of tears. - Is the glove too loose?
Does the glove feel loose? Is it tough to grip objects? If so, consider a smaller glove, as excess material may increase the risk of tears or punctures due to it snagging on other objects. - Does the glove fit correctly?
Is the glove comfortable to wear for extended periods? Does it feel like a second skin or like it is not even there? If so, you have found the right glove.
Use our GloveOn size chart to help you find the best glove fit to your hand size.
What is the measurement of glove thickness and how does it affect glove applications?
The thickness of disposable gloves is measured in mils. A mil equals one-thousandth of an inch (0.001 inch). Disposable gloves can be as thick as 8 to 15 mils, but general purpose disposable gloves are typically 2 to 4 mils thick. For comparison, a plastic grocery bag is around 3 mils thick.
Thinner gloves are usually preferred by phlebotomists due to better dexterity and lesser hand fatigue. Thicker disposable gloves will be used for specific purposes. E.g. tattoo artists prefer to use 4-6mil 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 gloves generally provide longer permeation timeframe when working with chemicals.
Thinnest gloves offer least protection to the users. Is that true?
This is a common misconception by most glove users. Users should not judge the level of protection purely based on glove’s thickness. Instead, it is best verified against the various performance requirement testing that the gloves have underwent according to the relevant international glove standards.
At Hartalega, with the modern advancement of glove technology, thin gauge nitrile gloves with thickness as low as 2.0mil perform as well as the thicker gloves in terms of physical properties. In addition, thinner gloves provide greater cost saving, with improved dexterity and user’s comfort.
Shouldn’t a glove that is only half as thick be half the price?
The best way to explain the cost of the glove is to first understand the components that go into making the glove: the raw materials, labour and other fixed costs as well as the final gram weight of the gloves.
Although we, in fact, can reduce the cost of the raw materials when making the gloves thinner, the manufacturing overhead and other fixed costs to make each glove do not change – in fact the manufacturing costs become a larger portion of the cost of the glove (e.g., thinning out the gloves from 4.0 mil to 2.0 mil does not enable the manufacturing line to make twice as many gloves nor does it cut the labour costs).
Some dentists’ feedback with regards to nitrile glove usage is that it is slippery and cannot hold well to dental equipment. Is this a common setback as compared to latex gloves?
Generally, latex gloves exhibit better wet grip and hence feel less slippery. However, with the latest technology employed in glove production, nitrile gloves have significantly improved in wet grip. During the initial period of glove switching from latex to nitrile, users might need some time to get accustomed to the different characteristics and ‘feel’ of nitrile and latex gloves.
Why do some gloves turn brown when I put them on?
Several factors can affect glove discoloration:
- Acidic perspiration may react with chemical additives in the glove resulting in discoloration.
- Chlorination can result in darker cuffs. This is not a problem unless there is a notable loss of strength as seen in over-chlorinated or over-heated gloves.
- A chemical reaction between residual nicotine deposits (found between the index and middle finger where a smoker holds cigarettes) and manufacturing chemicals such as carbamates may stain the glove.
- Metabolic copper or iron, or handling objects made of such metals, may also result in glove staining.
Is it possible to disinfect medical gloves?
Medical gloves are not intended for disinfection and re-use (World Health Organization’s Glove Use Information Leaflet). Therefore, this lies beyond the scope of risk assessment by the manufacturer. Such practice means a health risk for the patient and the health care workers (risk of infection, skin damage), since microfine glove lesions and the result of disinfection are both invisible. In legal terms, any person who changes the intended application acts as a manufacturer and thus accepts liability in the case of infections (damages).
Can medical gloves be reprocessed and reused?
Medical gloves are single-use items for safety reasons and the reprocessing of used disposable medical gloves for reuse is not recommended for the following reasons:
- Soiled used medical gloves are usually highly contaminated. Reprocessing of these gloves may not be able to completely decontaminate them, basically due to the glove design.
- Used gloves also contain different levels of soiled biological and chemical materials which can make cleaning and sterilisation of the reprocessed gloves difficult.
- In addition, certain chemicals may be released during reprocessing, which can cause adverse irreversible chemical reactions to the gloves such as dissociation of crosslinks.
- As such, reprocessing can cause deterioration in the properties of gloves, such as tensile strength, resulting in reduced durability of the final products.
- Reprocessed gloves may also contain endotoxins from the dead bacteria found in the soiled gloves.
Currently, there is no validated method available for addressing the above risks. Until such a method is developed/established, healthcare workers are advised against the use of reprocessed medical gloves.
How should I store gloves?
Improper storage will promote glove degradation and shorten shelf life. Store gloves in their original packaging in a dry, ventilated environment. Do not store above 40°C. Avoid direct sunlight, fluorescent lighting, heat and moisture. Continually rotate stock using the first in, first out (FIFO) concept.
What is the typical shelf life of a box of gloves?
In general, gloves have an average shelf life of 3 to 5 years. This time frame can be affected by general storage conditions such as heat, humidity, exposure to direct sunlight or fluorescent lighting.
Can we use expired medical gloves? Do they offer the protection needed?
Medical gloves were designed to serve as protective barriers and may still offer some protection even when they are used beyond the manufacturer’s designated shelf life or expiration date. The user should inspect all gloves prior to use and if there are concerns such as discoloration, visible holes or tears, the product should be discarded. As a conventional capacity strategy, it is preferred that expired gloves are used where barrier protection is not needed.
What are the recommendations for glove disposal?
Gloves contaminated with blood or body fluids, infectious agents or biological matter should be disposed of as clinical or potentially infectious waste. Non-contaminated gloves may be disposed of as domestic waste. Follow infection control guidelines and recommended practices for glove disposal.
