First, let’s remind ourselves and understand the EU standards relating to disposable gloves:
In February 2020 the ISO 21420:2020 standard came into force superseding EN 420:2003+A1:2009 and thus becoming an international standard. As everyone might know, this norm relates to the new general requirements for protective gloves. This new standard applies to PPE gloves (reusable gloves and disposable gloves) used in the laboratory and cleanroom workplaces. It is the responsibility of manufacturers of disposable gloves, such as latex gloves or nitrile gloves, to ensure that their PPE gloves are compliant with this new standard.
The ISO 21420:2020 Standard “specifies the general requirements and relevant test procedures for glove design and construction, innocuousness, comfort and efficiency, as well as the marking and information supplied by the manufacturer applicable to all protective gloves”.
All protective gloves, covering all categories of PPE, must satisfy these requirements and test reports issued by authorized testing facilities are mandatory for categories II and III.
Among the requirements is sizing information. Clause 5 “comfort and efficiency” in the standard outlines in particular the requirements for “sizing and measurements of gloves”. Sizing is defined according to the sizes of the hands on which gloves are intended to fit. A major change is that the minimum length specifications in EN 420:2003+A1:2009 no longer exists. The minimum glove length can be defined and measured only if required for a specific use (e.g.: for welders or firefighters). Glove sizes are now defined between 4 and 13 and the ISO 21420:2020 Standard allows the addition of extra sizes and half-sizes if needed. ISO 21420:2020 requires manufacturers to define their own sizing system according to the size of the hands on which the gloves can fit. The criteria assessed to determine sizing includes hand length (the distance from the wrist to the tip of the middle finger) and hand circumference (Annex B of the standard). In case of deviation from the standard, the information should be featured on the User Instructions leaflet.
Specifically with regard to glove length, note that a regular disposable latex or nitrile glove is generally 240 mm/9.4” long meaning the gloves cuff covers only a small area of the wrist.
Extra-length gloves, such as 250 mm/9.8”, 260mm/ 10.2” or 300 mm/11.8” are recommended to ensure a better forearm protection.
Taking all this into account, how do we select the right disposable latex or nitrile glove according to the environment or activity?
It’s worthwhile remembering that wearing protective gloves not only protects the worker against hazardous chemicals (danger of immersion or splashes) and biological hazards (infection or contamination), but also the process and products (from particle contamination).
Therefore, selecting the appropriate hand protection can be difficult in laboratory and cleanroom workplaces. It is essential to consider the most important factors (including the nature of the hazard, the task, the worker, and the workplace environment) collectively and not separately.
Workers in the laboratory need to consider the following criteria in the selection of latex gloves or nitrile gloves:
• What are the risks associated with the chemicals I am handling? To which biological hazards am I exposed? Etc.
• Are disposable or reusable gloves recommended?
• Which disposable latex or neoprene or nitrile gloves are appropriate to protect me from incidental chemical splashes or contact with chemicals or biological hazards?
• Do I need short or longer gloves?
Checking the Product Data Sheet for information on material, length, thickness and relevant standards is one way to choose the right latex gloves or nitrile gloves according to the risk. Additional help can be found in the disposable glove manufacturer’s chemical resistance guide (the latter details breakthrough time according to EN 16523-1:2015+A1:2018 and degradation according to ISO 374-4:2019). To support users in their risk assessment, SHIELD Scientific provides an extensive Chemical Resistance Guide, which is available online. Here you will be to select your gloves according to the highest level of resistance to the chemicals to which personnel are exposed. If this information is not available, an alternative is to check the recommendations in the Safety Data Sheet (SDS) of the specific chemical under section 8 “Personal protective equipment”. Typically, information is provided on splash contact and continuous contact.
For some chemical and biological risks, having a longer glove in the laboratory workplace may be the preferred solution to ensure maximum protection of the wearer thereby not leaving any part of the skin uncovered.
For cleanroom environments, it’s a quite different story as additionally the process and the product may need to be protected from particle contamination:
In the cleanroom workplace, the most common cleanroom glove length is 300mm/11.8”. This length is in general enough to cover the hands and the wrist to avoid release of skin particles and bio contamination (as is well known humans are the primary source of contamination in a cleanroom). These 300 mm/11.8” cleanroom latex/nitrile gloves also offer good anchorage to the forearm. In recent years, we have observed an increase in usage of extra-long nitrile gloves and latex gloves in many cleanroom facilities. According to the latest revision of the EU GMP Annex 1 draft: “Manufacture of Sterile Medicinal Products”, when working in the most critical areas it is now recommended to do regular sampling of the sleeve (article 9.32) as well as the hand to demonstrate that there are 0 CFU – Colony-Forming Unit – (prior to this revision, the specifications on the sleeve was 5 CFU and no regular disinfection on the sleeve was necessary). With a longer sterile glove (from 400 to 600 mm) it is possible to spray the entire arm area with IPA, thereby minimizing the risk of deviations and associated lost production time.
This is clearly not possible with a 300 mm glove because the sleeve of the coverall may become soaked after regular spraying with IPA. Several well-known global pharmaceutical companies with Grade A/B cleanroom production facilities have already moved to longer gloves in anticipation of the introduction of these new regulatory requirements.
To conclude, it is important to assess the length of the glove you require. Typically, the ideal length of laboratory and the cleanroom glove will vary depending on the level of personal and environmental protection you desire.
REMEMBER that a glove is a PROTECTIVE film. The CLEANER, THICKER and LONGER the film, THE BETTER YOU and YOUR ENVIRONMENT ARE PROTECTED!
SHIELD Scientific offers disposable gloves from 240 mm/9.4” to 600 mm/23.6 ” length to fit the needs of users in laboratory or cleanroom environments and to meet the personal protection requirements.
To help you select the right glove, visit our online Glove selection guide or our Chemical Resistance Guide or even better contact your SHIELD Scientific Representative. She/he will work closely with you to determine the best laboratory glove or cleanroom glove you need. She/he will evaluate with you the most appropriate latex glove or nitrile glove length option!