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With pressure building from regulatory bodies and employees regarding the allergy risks associated with natural rubber latex, the drive towards nonlatex gloves looks set to grow
Harry Kirk
Business Development Director
Nitritex Ltd
Newmarket
Suffolk
UK
Various studies have verified that immediate (type 1) hypersensitivity to natural rubber latex appears to be caused by certain naturally occurring soluble allergenic proteins found in latex.1 Additionally, a range of processing chemicals are used during the manufacture of natural
rubber latex products that may cause type 4 allergic
reactions.[1]
Type 1 latex allergy receives the most attention due to its potential to kill. However, type 4 allergies are much more common. The main causes of type 4 allergies are:
- Exposure to perspiration inside the glove (contactdermatitis).
- Contact with chemicals remaining on the glovesurface after manufacturing (irritant dermatitis).
These type 4 reactions, described as immune responses to chemical allergens, can be caused by chemical accelerators used in the glove manufacturing process. Such accelerators are present in the vast majority of disposable gloves in use today, including those manufactured from latex, vinyl and other synthetic rubber products. Symptoms manifest themselves as skin reactions, erythema blisters, constant itching, broken skin and chronic rhinitis.
Concerning hand protection, in order to reduce the incidence of type 4 allergies it is important to wear a glove that has been leached (washed) postproduction to ensure a very low or undetectable level of extractables. It is an unfortunate fact that many nonlatex gloves have been the cause of type 4 allergies.
While substantial efforts have been made to reduce the level of proteins and accelerators in disposable latex, nitrile and vinyl gloves, only a handful of specialised producers have been able to eliminate them completely. As a result, allergies occur frequently. This is particularly true for staff working in controlled and critical environments, many of whom are wearing gloves for extended periods.
The usage of gloves manufactured from natural latex has dramatically increased in recent times. It has been estimated that, consequently, up to 30% of users in the UK have atopic allergy and 43% have some sort of skin irritation.[2]
Within these groups a latex sensitivity of 10% has been observed, indicating that 3% of all users are at risk.2 An allergic reaction to latex proteins (type 1) is typified by an almost immediate hypersensitivity and results in anaphylaxis (hypertension, rash and bronchospasm).
Legal considerations
All employers have a duty of care to their employees – that is, to ensure that employees are not exposed to any activity that might be considered harmful to themselves or their fellow workers. This includes the provision of gloves for employee protection.
It is virtually inevitable, then, that if an employer continues to insist upon employees wearing latex gloves at some time in the future one or more of their employees wearing latex gloves as an integral part of their workwear may develop a latex protein allergy. That would constitute a breach of the employer’s duty of care, especially when it could be proven that alternative nonlatex gloves were available that could have prevented type 1 latex protein allergy.
The allergy solution
For several years research has focused on alternative polymer materials that could be manufactured into gloves, using an aqueous-based, environmentally friendly process and that have the following key attributes:
- Free of latex proteins.
- Accelerator-free.
- Strength and elasticity.
- Comfortable to wear.
- Environmentally friendly.
In an effort to offset the risks associated with the use of natural rubber latex, many glove manufacturers have turned to alternative materials made of plastics and synthetic rubber.
Glove manufacturers have been searching for a competitively priced, quality alternative to natural rubber latex, and many offer nitrile, neoprene, vinyl and polyurethane as viable alternatives. Moreover, many believe that, after latex, co-polymers offer the best elasticity and comfort. Gloves made with co-polymers have excellent strength (similar to nitrile) and elasticity (similar to latex) and have no odour – attributes that all significantly enhance the wearer’s comfort.
Issues facing organisations looking to change from Hlatex gloves to nonlatex alternatives include:
- Comfort and dexterity. Many tasks in cleanroomsinvolve work of a delicate nature, frequently requiring great dexterity. If a glove is too thick it will have poor tactility, which will make delicate or fine work difficult. It may also take considerably longer to finish. In either event, productivity is reduced. When employees are wearing gloves for long periods, it is vital that the gloves are comfortable. Hand fatigue is a major problem if gloves are not made to provide an anatomical fit. Some nonlatex gloves do not have an optimal anatomical fit, and, when that is combined with low elasticity, hand fatigue can become a major issue, leading to reduced dexterity.
- Price. Although there has been a steady increase in the usage of nonlatex sterile cleanroom gloves, the price of nonlatex gloves has remained higher than that of gloves made of natural rubber latex. When all companies are looking to save money rather than increase costs, the higher price has been a major barrier to a move towards nonlatex gloves.
But what if a nonlatex glove could be found that answered all concerns – comfort, dexterity, type 1 allergies, type 4 allergies and price?
One company that is currently making inroads into the nonlatex glove market is the UK-based firm Nitritex Ltd. A manufacturer of cleanroom consumables, Nitritex has introduced its BioClean™ range of sterile nonlatex cleanroom gloves, which have been developed to provide nonlatex users with the best available alternatives. Manufactured from a proprietary blend of synthetic polymers, gloves from the BioClean range are:
- 100% latex-free to eliminate type 1 latex protein allergy.
- Anatomically shaped and made with a supersoft formulation to eliminate hand fatigue and give excellent user comfort.
- Extensively leached to dramatically reduce the incidence of type 4 allergies.
- Priced to compete directly with latex gloves.
One trend is certain: the drive towards non ltex gloves will continue. Pressure is building from, on one front, regulatory bodies looking to avoid costly lawsuits and, on another front, from employees who are becoming increasingly educated regarding the risks that are associated with natural rubber latex.
References
1. Turner P. Latex glove allergy. Occupational Health 1997;49(2):57-60.
2. European Commission. Guidelines on medical devices. Implications of the medical devices directives (93/42/EEC)
in relation to medical devices containing natural rubber latex.
Report no. MEDDEV 2.5/9, rev.1. Brussels: EC; 2004.