World’s safest medical glove?

Latex allergy affects around 17% – or more than one in ten – of the world’s healthcare workers. For most people, the symptoms are relatively mild, resulting in an itchy red rash. For many others the problem poses a life-long health risk and may sometimes wreck careers. In the most severe cases, sensitivity to the proteins found in natural rubber latex (NRL) – Type I latex allergy – can cause anaphylaxis and even death.  For healthcare workers affected by either Type I or non-life-threatening Type IV latex allergy1, the effects can be devastating. As the symptoms only grow worse with each repeat exposure, some are eventually forced to abandon their chosen profession, a huge waste of talent that is often at considerable cost to the healthcare provider.
 

Type IV Hypersensitivity
Also called allergic contact dermatitis, delayed hypersensitivity, and chemical allergy; is a cell-mediated allergic reaction associated with specific chemicals called chemical contact sensitisers. This is a delayed reaction that typically takes from six hours to 48 hours for maximum expression of physical symptoms. An individual must be genetically predisposed to have this allergic reaction. Type IV allergic contact dermatitis is characterized by localized skin redness and inflammation (erythema), small skin elevation or blisters (vesiculation), a localised, itchy rash (pruritus), and dry, thickened skin that can peel or crack. The area affected usually spreads, increasing in size from the point of origin, with repeated exposure. Examples include Type IV allergies to: poison oak, nickel, soaps, fragrances, and chemicals such as accelerators used in glove manufacturing (thiurams, thiazoles, and carbamates).

Synthetic polymer gloves have not solved the latex allergy problem. In fact nitrile gloves may actually increase the number of cases of Type IV latex allergy, a form of debilitating contact dermatitis brought on by chemicals used during glove manufacture. The chemicals responsible – known as accelerators – are often present during manufacture of synthetic gloves. Indeed, according to the UK Royal College of Physicians: “It is conceivable that changing to latex alternatives may only substitute one set of problems for another.” [UK Royal College of Physicians (Latex allergy: occupational aspects of management)]

NRL not only has the advantage of being a natural renewable product, but it is also inherently stronger and more flexible than many synthetic polymer alternatives. Most medics claim to much prefer the comfort and fit of NRL gloves, particularly when carrying out delicate procedures requiring a degree of manual dexterity.

Natural rubber latex from the Hevea brasiliensis tree contains roughly 200 different proteins. Fourteen of these have been described and characterized as allergens by the WHO/IUIS Allergen Subcommittee. Out of these 14 different allergens, only four have been known as major latex allergens: Hev b1, 3, 5, and 6.02.
 

Compelling Evidence
Medical gloves have to meet strict international requirements. The most commonly applied test for measuring the protein content of latex gloves in the industry is the Modified Lowry method, which allows manufacturers to determine the total protein concentration. Industry focus is below 50μg/g (microgram per gram), which is considered as a reliable quantitation level of the Modified Lowry standard. Gloves that satisfy the Modified Lowry standard could still potentially trigger a latex allergy – and may even be highly allergenic depending on which particular protein types are present.

Allergen specific IEMA (immuno-enzymometric assay) method (ASTM D7427; FITkit) has an overall protein quantitation level more than 300 times lower than Modified Lowry. IEMA specifically determines the levels of each of the four major proteins (allergens) known to elicit latex allergy: Hev b1, 3 and 5, and Hev b6.02. The quantitation levels of FITkit are the lowest in the world. The IEMA method shows excellent correlation to the patient IgE-based ELISA inhibition method that was previously validated by skin prick testing in voluntary NRL-allergic patients. These methods are the next best alternative to actual clinical latex allergy tests on people, which are normally not performed for ethical reasons.
 

Toward Allergy-Free Latex
To date, no manufacturer is legitimately able to make the claim they have developed an allergy-free latex glove. However, Dutch R&D company Budev’s MPXX technology comes closest to making this a reality.

Cleantexx glove samples, made by using the MPXX washing process, have been subjected to the most comprehensive suite of testing procedures – with protein detection levels at orders of magnitude far below the current industry standard. Furthermore, Cleantexx glove samples have also been subjected to chemical residue testing procedures – with chemical residue levels also far below industry standard. Based on these results, it is believed that they are the cleanest available on the market – with unquantifiable protein and chemical levels even by the most stringent tests.²

Budev BV
Bloemendaal, The Netherlands
budev.com

 ²Cleantexx gloves are constantly subjected to amongst others the following tests: RAST inhibition, Mod. Lowry, Amino acid analysis (HPLC), FITkit, SDS-page, overall migration, primary skin irritation and chemical residue