Kossan Rubber Industries Bhd
General Information on Gloves
Glove Manufacturing
Quality, Standards & Regulations
Glove Allergies
Articles / White Papers
What is natural rubber latex?
A white milky fluid obtained by tapping the bark of Hevea brasiliensis trees. The latex consists about 30% of rubber hydrocarbon finely dispersed in the aqueous medium. Like all living plants, latex from rubber trees also contains growth related substances such as proteins, carbohydrates and other organic and inorganic substances, albeit in small quantities. The latex has to be concentrated to about 60% dry rubber content and stabilized with chemicals to maintain its fluid state. The latex concentrate is then added with vulcanizing ingredients and other chemicals so that the mixed latex compound can be converted into finished goods by either dipping, extruding, or coating process. In the manufacturing of medical gloves, the dipping process is employed.
What are the benefits of natural rubber latex gloves?
  • Natural Rubber Latex glove provides superior barrier protection against the transmission of viruses such as HIV, hepatitis B and C, and other blood-borne diseases.
  • Natural Rubber Latex gloves also provide high strength and elasticity, comfort, fit and feel. All these properties of natural rubber thin film make natural rubber latex gloves, the perfect choice in glove selection.
What are the difference in characteristic for the latex, nitrile and vinyl material examination gloves?
MATERIAL Natural rubber latex from the rubber tree. Heven brazilliensis. A synthetic copolymer made up from monomers of carboxylic acid, acrylonitrile and butadiene. Polyvinyl chloride, a synthetic co-polymer.
BARRIER PROTECTION Natural rubber latex has good film formation properties and the natural rubber latex film provides superior barrier protection. Nitrile latex film exhibits comparable barrier protection as natural rubber if the film is continuous. Vinyl gloves contain up to 40% plasticizers in order to provide the soft feel. As such, vinyl gloves are the least elastic among the three materials and provide the worst barrier protection.
STRENGTH Superior. Excellent strength and puncture resistance. Limited.
ELASTICITY High levels of elasticity, memory and elongation provide excellent fit. Medium to High conforming to the user's hand with use. Low to Medium, with moderate flexibility. Lower elongation properties result in a loose-fitting glove.
DURABILITY High resistant to tear and puncture. Have superior dynamic durability. High resistant to puncture and tear. Exhibits moderate dynamic durability. Poor dynamic durability that declines with use, resulting in medium to high in-use failure rates.
CHEMICAL RESISTANCE (incidental exposure) Depending on the type of chemicals in contact. Generally good. Depending on the type of chemicals. Generally good to excellent. Depending on chemicals. Generally poor.
GLUTARADEHYDE USE Fair, AAMI recommended use for short-term, incidental contact only. Excellent, recommended by AAMI. Poor, not recommended by AAMI.
COMPATIBILITY WITH LOTIONS Water-based only. Water-based and petroleum-based. Water-based and petroleum-based.
  • Immediate Type I hypersensitibity caused by certain natural rubber latex proteins.
  • Delay Type IV hypersensitivity due to certain types of accelerators used in the vulcanization process.
  • Delay Type IV hypersensitivity due to certain types of accelerators used.
(Nitrile gloves manufactured without chemical accelerators have been launched by KOSSAN under Chemax 7th Sense to address this issue)
  • Plasticizers used in vinyl gloves have shown to be carcinoginic.
  • Chemical Allergies (Type IV)
FIT AND COMFORT Excellent, conforms to hand. Good to Excellent, conforms to hand. Fair, loose-fitting.
COST Low to Moderate. Moderate to High. Low to Moderate.
RECOMMENDED USE Optimal choice based on overall performance. Material strength supports use in high-risk situations and potential exposure to blood-borne pathogens. Latex-like properties make this an ideal synthetic alternative for latex-sensitized individuals. Premier choice for use in high-risk situations, including infectious agents and most chemicals. Low risk situations where exposure to blood-borne pathogens is limited and for short-term, minimal stress situations.
What are the different classifications for surgical, examination and specialty gloves?
Surgical gloves are categorized as Class II medical devices according to the European Directive MDD 2007/47/CE. The gloves are designed specifically for surgical procedures. Surgical gloves are primarily used to prevent cross contamination between surgeon to patient and vice versa during invasive medical procedures. Examination gloves are categorized as Class I medical device and are designed for use when conducting non-invasive medical examination, diagnostic and therapeutic procedures and for handling contaminated medical materials. Examination gloves are primarily used to prevent cross contamination.

Specialty gloves are custom designed for protection against extreme conditions such as high risk situations and dealing with chemotherapy materials. This will be further elaborated in section on PPE.
What are the differences between examination and surgical gloves?
  • Examination gloves are ambidextrous in design while surgical gloves are designed hand specific. Surgical procedures are extremely critical and require precision movements and hand Specific design enables better fit and movement.
  • Examination Gloves are usually non-sterile while surgical gloves must be sterilized. The sterility of surgical gloves is essential to avoid bacteria or virus contamination to the patient wound during surgical procedures.
  • Examination gloves are normally thinner and shorter length compared to surgical gloves due to the nature of procedure which is less critical (non-invasive) as compared to the more critical surgical procedure.
Why do gloves come in different colors?
Generally, natural rubber latex gloves come in pale white colour. In an attempt to distinguish the synthetic gloves from the natural rubber gloves, pigment was added to the synthetic gloves. This will facilitate in glove selection, especially for people who have been sensitized by latex proteins and should not use natural rubber latex gloves. Nowadays, glove colors can often be used to help identify contamination or designated critical work areas. Some gloves are colored to differentiate the type of primary material used, as well as to clearly distinguish the subject of examination or surgery.
How do we determine the right glove size?
Use a tape measure to find the circumference of your hand around the palm.

This measurement (in inches) is the closest to your glove size. For example, if your hand measures 8 inches, you probably wear a size 8 glove.
When should medical-grade gloves be worn?
Due to the AIDS epidemic, the US recommended a strategy in 1985, known as universal precautions. The purpose of these precautions is to protect healthcare workers from exposure to blood and other body fluids from patients infected with bloodborne pathogens. Hence, medical-grade gloves should be worn whenever there is a probability of hand contact with skin, blood, mucous membranes, body fluids as well as cleaning and disposal of infectious materials and equipment. Healthcare workers are advised to change gloves after contact with each patient and do not reuse gloves.
What can you do to make sure the gloves will be an effective barrier?
  • Select high quality gloves including the right glove size
  • Adopt proper donning technique
  • Consider the duration of glove wearing and removal
  • Double gloving if needed
  • Appropriate glove storage/usage
  • Wearers of natural rubber gloves should avoid contact with oil-based lotion/hand sensitizers
  • When wearing medical gloves, one should have well trimmed fingernails and remove all hand jewelry
How often should you change gloves?
  • Between patients
  • Between procedures
  • If gloves become contaminated/prolonged contact with blood/body fluids
  • Going to a clean site after working on a contaminated site
  • If gloves are torn, cut or punctured
  • Sterile gloves are contaminated by touching something non – sterile
  • If gloves have been in contact with oils
  • Gloves should be changed often during lengthy procedures
What are the Dos and Don’ts of glove use?
  • Ensure hands are properly washed before and after donning gloves.
  • Medical gloves are recommended for single use and should be immediately disposed after use.
  • Do not leave gloves on along hallways or outside the examined area, as the gloves might contaminate or contract infectious agents along the way.
  • Proper glove size and fitting is important. Tight fitted gloves will restrain movements resulting to hand fatigue while overlarge size gloves will affect dexterity causing spillage and error in precision.
  • Gloves should not be stored under high temperatures as this will evidently cause product degradation.
  • Always remember to remove gloves when handling office equipment and stationary to avoid contamination.
  • During prolonged procedures, gloves should be changed periodically.
  • Select proper glove characteristics for intended application such as grip, length, thickness, primary material, dexterity, cuff type, physical properties, surface treatment or coating, resistance to biological and mechanical hazards.
  • Avoid direct immersion and prolonged exposure of gloves during handling of biological hazards.
  • Double gloving provides a secondary line of defense against contracting infectious agents.
Why should we double-glove?
Double-gloving (wearing 2 sets of surgical gloves) minimizes the surgeons from potential exposure to bodily fluid during surgery. It provides a reassurance, especially in surgery where instruments with sharp edges are encountered and may cut or tear gloves.
What factors should be considered when selecting gloves?
  • Low in endotoxin
  • Powder-free
  • Low in residual chemicals
Type IV – hypersensitivity
  • Low in residual accelerators used in vulcanization process
  • Not using sulfur and accelerators vulcanizing system
Type I – hypersensitivity including occupational asthma
  • If natural rubber gloves are used, select those with low extractable latex protein level and powder-free.
  • Select gloves made from synthetic latex such as nitrile latex.
What is latex compounding?
Films made from natural rubber latex or synthetic latex, on their own, are not functional. In the raw state, they are soft and not elastic. The rubber molecules of natural rubber latex and synthetic latex have to be cross-linked into a network to provide the necessary mechanical strength and hardness for the product to be functional, i.e. this process of crosslinking or vulcanization will allow the product to be elastic and stretchable, suitable for glove application. Crosslinking of rubber molecules which carry unsaturated double bonds can be effectively carried out using sulfur and other chemicals which act as accelerators and activators to enhance the crosslinking process. To develop a latex compound for making gloves involve the following steps:
  • Choosing the raw latex/chemical ingredients/additives
  • Developing a formulation
  • Working out an appropriate mixing procedure for all the ingredients
  • Making an experimental batch
  • Running some tests if the gloves so produced provide the desired properties
  • Finalizing the recipe/formulation
  • Scaling up to a factory scale to produce gloves
What are the components found in a latex compound?
Several materials are needed in a latex compound. The latex used can either be natural rubber latex, synthetic rubber latex such as nitrile latex, polychloroprene latex, polybutadiene latex or polyisoprene latex. Next comes the vulcanizing/crosslinking system.
Other components include the following:
  • The stabilizers: surfactants, emulsifiers
  • Processing aids: wetting agents, dispersing agents, foaming agents, foam stabilizers, viscosity modifiers
  • Protection system: antioxidants, antiozonants, antidegradants, waxes
  • Properties enhancement materials: fillers, pigments, plasticizer.
Typical latex compound formulation is given below for a natural rubber latex compound.
Potassium hydroxide solution 0.3 – 0.5
Additional stabilizer (fatty acid soap) 0.05 to 0.2
Sulfur dispersion 0.4 to 1.2
ZDC accelerator dispersion 0.3 to 1.0
Zinc oxide dispersion 0.1 to 1.0
Antioxidant dispersion 0.5 to 2.0
Pigment dispersion 0 to 0.5
Defoamer as required
Dewebber as required
Water as required
Why are chemical accelerators used in glove manufacturing?
Because of its low cost, ease of availability and minimal interference with other compounding ingredients, sulphur is the most important crosslinker used in latex compounding. However, vulcanization of rubber molecules using sulphur alone is very slow. Even at elevated temperatures above 140oC, it will take a few hours for vulcanization to complete. Ideally, the sulphur curing system must include activators and accelerators. Activators (usually metal oxide e.g. zinc oxide in combination with stearic acid) can catalyze the reaction. Accelerators are organic substances that accelerate vulcanizing reaction. In the presence of activators and accelerators, the crosslinking process can complete in 15 to 20 minutes at 140 C.

Most of the common accelerators suitable for latex are metal dialkyl dithiocarbamates such as zinc dialkyl dithiocarbamates ZDC, thiouram polysuphides and thiazoles. These accelerators are used in both the natural rubber latex and synthetic latex glove production. Unfortunately, most of these accelerators, if present in gloves, have the potential to induce delay Type IV hypersensitivity of contact dermatitis allergy.

Note: (In 2008, KOSSAN launch a new breakthrough in nitrile examination glove under the brandname Chemax 7th Sense without the need for accelerator chemicals, making the users of these gloves less susceptible to Type IV allergies.)
In glove manufacturing, how does one remove the excessive accelerators?
To reduce the presence of residual chemicals such as accelerators in gloves, one must only use the optimal amount of the chemicals in the compound formulation to avoid excessive usage of chemicals. Any unreacted chemicals i.e. as residual chemicals in gloves should be leached away in the processing step known as leaching. Leaching refers to the process of immersing the latex–coated formers into a bath, to wash out the excess additives from previous stages. In natural rubber gloves, extractable latex proteins can also be leached out at this stage.
What are the alternatives to powder in reducing tackiness?
Chlorination reduces the stickiness of the latex by modifying the rubber surface for easy donning as well as reduces the amount of extractable proteins either by: denaturing the protein and leaching

Polymer Coating creates a slippery surface on the inside of the glove which aids donning. The coating may also act as a barrier between the users’ skin and the latex in reducing the exposure to the latex proteins.
How should gloves be stored to avoid degradation?
The shelf life of the gloves is estimated at 3-5 years (depending on the type of glove) from the date of manufacture. The storage period is applicable provided the following storage conditions are adhered.
  • Rotate the supply of gloves so that the oldest supply is used first
  • Keep gloves in their original box until they are needed
  • Avoid direct sun and fluorescent lighting
  • Stored with temperature not exceeding 40 degree C
  • Storage area should not contain equipment that generate ozone ( example: x-ray machines, mercury vapor lamps, high voltage electrical appliances or appliances that give rise to electrical sparks or discharges
  • Avoid direct contact to metals
  • Avoid contact with oil-based antiseptic phenols, greases, petroleum jelly, spirit, parafins and other related compounds
Can ‘single use’ products be reused?
According to Annex I (13.6h) of the Council Directive 93/42/EEC, as amended by the Council Direction 2007/47/EC, concerning medical devices, we declare under our sole responsibility on the implication of reuse on single medical device. The reuse of single-use devices can affect their safety, performance and effectiveness, exposing patients and staff to unnecessary risk. Potential hazard has been identified as follow:
  • Loss of sterility
  • User may face allergy reactions
  • Loss of glove barrier integrity
  • Loss of glove physical properties
Single use medical device is intended to be used in surgical work and to be worn once and then discarded. The reuse of single-use devices has the following legal implications:
  • anyone who reprocesses or reuses devices intended by the manufacturer for use on a single occasion bears full responsibility for the safety and effectiveness; and
  • anyone who reprocesses a single-use device and passes it to a separate legal entity (for example, the independent healthcare sector) has the same legal obligations under the Medical Devices Regulations as the original manufacturer of the device.
What is the purpose of glove testing?
Glove testing is carried out to ensure that the products meet the national and international standards and specifications set for the products. It is also used to define and maintain product specifications, to monitor quality control and quality assurance of product and to measure the capability of the manufacturing process.
How do you define AQL?
AQL is the acceptable quality levels used in normal inspection. The AQL is defined in ISO as “When a continuous series of lots is considered, the quality level which for the purposes of sampling inspection is the limit of a satisfactory process average.” When a specific value is designated for a certain nonconformity, it indicates that the sampling scheme will accept the great majority of the lots submitted, provided the quality level (percent nonconforming per 100 units) in these lots is no greater than the designated value of AQL. It is the maximum percent defective (or maximum number of defects) per hundred units that are allowed in a product LOT. However, it must be remembered that the AQL is a parameter of the sampling scheme and should not be confused with the process average which is the operating level of the manufacturing process.
How do you quantify the protein and allergen levels in natural rubber(NR) latex products?
In attempts to measure the protein and allergen levels present in natural rubber latex products, several assays have been developed over the years. Quantification of proteins in NR latex gloves is of great interest both to the glove manufacturers and users. The amount present is, however, very much influenced by the manufacturing process.

Measurements of proteins or allergens are generally classified into two main groups; the chemical method and the immunological method involving ELISA. At the moment, measurement of total leachable protein of gloves by the modified Lowry tests appears to be the best available chemical method for manufacturers to monitor closely the extractable protein level of their gloves. Modified Lowry test is considered to be suitable for current production control, though it can be susceptible to chemical interference such as diphenyguadinine (DPG).
What is the Modified Lowry assay test?
The ASTM D 5712 described the Modified Lowry assay which is a chemical assay that measures all proteins. It was the first validated method and is available as a kit. The disadvantages of this assay are that it is not sufficiently sensitive to accurately quantitate low protein level and the assay is prone to the interference of chemical additives in natural rubber products. The ASTM D 5712 determines the concentration of total water – soluble protein present in a glove sample. The test results are expressed as micrograms of total protein per gram of product. The lowest limit of the test is considered to be less than or equal to 50 µg/g. This is currently the only test recognized by the FDA for the determination of the protein on latex devices.
What is the ELISA test?
ELISA is an abbreviation for "enzyme-linked immunosorbent assay." An ELISA test uses components of the immune system and chemicals to detect immune responses in the body. The tests are widely used to detect substances that have antigenic properties, such as proteins in NR latex. Various forms of ELISA assays are used to measure the level of antigens or allergens present in natural rubber latex gloves.
What is the LEAP assay test?
Unlike the chemical test, the LEAP assay is an immunologic method for the measurement of antigenic proteins. The Latex ELISA for Antigenic Protein (LEAP) is an ELISA that uses rabbit anti-natural rubber latex protein antibodies. The test is more sensitive than the Modified Lowry standard test and is also available as a kit. One of the drawbacks is that the assay format is not standardized. The test results are expressed as micrograms of antigenic protein per gram of glove. Currently, there is no regulatory requirement for antigenic protein testing.
What is the RAST inhibition test?
RAST stands for Radio-AllergoSorbent Test. The RAST inhibition assay is based on the reaction between the allergenic protein and the antibody (IgE). In the case of LEAP, the antibodies are IgG antibodies raised in rabbit, but in RAST inhibition assay, the IgE antibodies are from latex allergic patients. The RAST inhibition assay is a serological in-vitro test requiring only the blood serum containing the latex specific IgE antibodies. This test measures the allergenic protein level of gloves.

For the detection of glove allergens, RAST-inhibition and IgE-ELISA inhibition are being used. However, until now, it has not been possible to standardise these assays because of lack of availability of standardised human antibodies and standardised allergens.
What is skin prick test?
The skin prick test is a clinical text which has more specificity for latex allergens than those of the extractable protein measurements. The skin prick test evaluates the allergic reactions in-vivo whereby an aqueous protein extract introduced to an individual with an epidermal puncture. Reactions are gathered by measuring the typical wheal and flare reaction compared to a positive and negative control. A positive test result is an infraction of a latex sensitivity. It has been shown that the total extractable protein correlate relatively well with the skin prick test (SPT). One drawback of this test, however, is the availability of latex hypersensitive individuals, and their willingness to be tested.

Even though skin-prick testing is safe, it is essential that antihistamine medication and adrenaline should be readily available when performing allergen skin-prick testing. Although the technique looks quite simple, its interpretation requires a thorough clinical allergy history and an experienced practitioner.
What is patch test?
The test is carried out to test for rubber chemicals identified as specific chemical contact antigens often utilized in the manufacture of latex products. These suspected chemicals are mixed in a petroleum base which is applied to the patient’s skin. Results are ready 38 to 72 hours later. The presence of a rash, vesicles or papules indicates positive response. A positive result is an indication of sensitivity to that specific chemical.
What is Modified Human Draize test?
The test is a dermal sensitization test performed to demonstrate the potential of the device for eliciting a delayed hypersensitivity (Type IV) immunological response through its contact with skin. The test is conducted by repeatedly applying latex glove patches to human skin over a 6 – week period time. The results are determined based on the degree of skin reaction that is observed during the period tested.
What are the glove standards for MDD Directives?
Medical Device Directive (MDD) – 2007/42/CE
  • EN 455 Part 1, 2 and 3: Medical Gloves for single use

  • EN 455 – 1: (1994) Specification for freedom of holes (barrier properties)
    EN 455 – 2: (1995) Specification for physical properties
    EN 455 – 3: (2000) Requirements and testing for biological evaluation (biological properties/labeling)
    How is the EN 455 1, 2, 3 divided?
    EN 455 – 1: (1994) Specification for freedom of holes (barrier properties)
    EN 455 – 2: (1995) Specification for physical properties
    EN 455 – 3: (2000) Requirements and testing for biological evaluation (biological properties/labeling)
    Who is the Notified Body of KOSSAN?
    • British Standard institution (BSi)
    • Notified Body number 0086
    • Symbol CE 0086
    What does ASTM stand for and what are their responsibilities?
    ASTM - American Society for Testing and Materials. It is a not-for-profit organization that provides a forum for consumers, manufacturers, citizens, organizations, government representatives, and academia, to meet and write standards for variety of products, services, and materials. The FDA recognizes the ASTM standards and they are listed in the US Federal Register. Glove manufacturers must conform to these consensus standards in order to meet the requirements set forth by the FDA for the particular type(s) of medical gloves that they market.
    What are the current available ASTM Standards that are applicable for gloves?
    D 3577-00 Standard Specification for Rubber Surgical Gloves
    D 3578-00 Standard Specification for Rubber Examination Gloves
    D 5250-00 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
    D 6319-00 Standard Specification for Nitrile Examination Gloves for Medical Application
    D 5151-99 Standard Test Method for Detection of Holes in Medical Gloves
    D 6355-98 Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
    D 6124-00 Standard Test Method for Residual Powder on Medical Gloves
    D 6499-00 Standard Test Methods for the Immunological Measurement of Antigenic Protein in Natural Rubber and its Products
    What is ISO? Are there relevant medical glove standards in ISO?
    ISO means International Organization for Standardizations. ISO regularly publish standards which are audited for compliances by sanctioning organizations called “Notified bodies”.

    The relevant rubber medical glove standards are developed by the ISO Technical Committee TC 45, Sub Committee SC 4. These are:
    • ISO 11193 2008 Single-use medical examination gloves -- Part 1: Specification for gloves made from rubber latex or rubber solution
    • ISO 11193-2:2006, Single-use medical examination gloves - Part 2: Specification for gloves made from poly(vinyl chloride)
    • ISO 10282:2002 Single-use sterile rubber surgical gloves -- Specification

    Other standards developed by ISO which are relevant to the glove industry are those related to Quality Systems, ISO 9001: Quality systems for design, development, production, installation and servicing and ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes

    KOSSAN’s ISO Quality System Certification includes : BS EN ISO9001, & BSEN ISO13485.
    What is an allergy?
    An allergic reaction is an acquired abnormal response of the body’s immune system to a substance (an allergen) that does normally cause a reaction.
    Are all people prone to reactions from using gloves?
    The three types of adverse reactions associated with latex gloves affecting some users are irritant contact dermatitis, Type IV hypersensitivity and Type I hypersensitivity. The irritant contact dermatitis and Type IV hypersensitivity associated with natural rubber usage have been known for many years, however, that of Type I hypersensitivity emerged only in the late eighties.

    Irritant contact dermatitis is a non allergic response, and therefore all people can get an irritant reaction to gloves. However, Type I and Type IV are allergic reactions. This means that an individual must be genetically predisposed to the chemical contact sensitizers (Type IV) or latex proteins (Type I) in order to get these allergies.
    Who will normally get an allergic reaction from using gloves?
    • It is estimated that less than 1% of the general population (no specific number) are at risk
    • A number of high risk groups have been identified:
      1. 1. Healthcare workers: 2,8 – 16,9%
      2. 2. Spina bifida and multioperated children 32 – 50,6%
      3. 3. Rubber industry workers: 2 – 11%
    • Other glove users: 8 – 11%
    It must be reminded that these prevalence figures were obtained many years ago when the old generations natural rubber latex gloves had very high extractable protein contents very often exceeding 1000 microgram per gram of gloves. With the advances in manufacturing process and the understanding of the protein allergy issue, the extractable latex protein present in the new generation natural rubber latex gloves is very much reduced. In the case of powdered natural rubber latex gloves, the acceptable maximum protein content is 200 microgram per dm2 and for powder-free natural rubber latex gloves, it is not uncommon to have values below 50 microgram per dm2. It is therefore expected that the degree of latex sensitization is very much reduced even for healthcare workers. Nevertheless, people who have been sensitized should avoid further contact with natural rubber latex gloves.

    It is said that atopy seems to be a principal predeterminant for sensitization. It is interesting to note that, however, the prevalence among potential high risk groups in natural rubber producing countries such as Malaysia and Thailand is only 2% and about 3% respectively, despite repeated exposure to latex and latex products.
    What are some of the reactions affecting individuals through the use of natural rubber latex and synthetic gloves?
    Irritant contact dermatitis (Non-allergic) Skin rash, dry flaky skin with papules, cracks and sores. Residual soaps, hand cream, powder, temperature and pH extremes, disinfectants and incomplete hand rinsing.
    Type IV – Chemical hypersensitivity (cell-mediated allergy) Eczema appears at 48 hours to 96 hours post exposure by skin contact. Residues of chemicals used for processing of gloves, particularly, the thiurams and carbamates.
    Type I – Latex Protein hypersensitivity (IgE mediated allergy) Immediate localized itching, burning or discomfort, urticaria(hives) within 5 to 60 minutes after contact, rhinitis, asthma and in very serious cases, anaphylaxis (very rare). Residual extractable proteins found in natural rubber latex products.

    extracted from Malaysia rubber board monograph 1 “Latex Protein allergy and your gloves”
    What is a glove related irritation?
    Irritation is a non – allergic condition that can be experienced by anyone. It is an inflammatory reaction of tissues due to an injury. Irritations can be caused by soaps, detergents, disinfectants, solvents or degreasing agents, ethylene oxide, alcohol and other irritants. These are irritations that are not glove related. Glove – related irritations can be caused by glove powder, chemicals and endotoxins found in both latex and synthetic gloves. Two other important irritation factors are friction and air occlusion.

    If it is an acute irritation the hands can have a red, scalded appearance with possible swelling. After repeated or long – term exposure, acute symptoms can progress to a more chronic state where symptoms include hyperplasia, keratosis, ecema, peeling skin etc. Symptoms of irritation are only related to the area of glove contact. Irritation is not an allergic reaction. This reaction does not proceed beyond the boundary of the glove.
    What is an allergen?
    A substance, usually a protein that is able to elicit an IgE antibody response and activate mast cells. Allergenic proteins are proteins that the body recognizes which we call antigenic proteins and they are capable of initiating an allergy.

    Every allergen is a type of antigen, but not every antigen is an allergen. Thus it can be said that in natural rubber latex gloves, not all extractable proteins are antigens and not all extractable proteins are allergenic proteins.

    Are low levels of total proteins important?
    A It is not a perfect predicator of allergenic protein content, generally speaking. If the total levels of proteins in a glove are high, the higher the allergenic protein content. However the lower the total protein content is in a glove the lower the allergen. It is accepted scientifically that the sensitization of genetically predisposed individuals is amount and rate dependent; this is making it extremely important to select a glove that is low in protein allergens. The lower the level of total protein, the lower the probability of exposure to potential protein allergens.

    The Malaysian Rubber Board has previously conducted a study relating level of extractable proteins of gloves to response of sensitized people in skin prick test. It can be seen that for gloves having protein level below 300 µg/g of glove, more than 80% of sensitized person do not show positive response to skin prick test.

    Latex protein allergy and your gloves
    (Malaysian Rubber Board Monograph No. 1)
    Recent Advances in the Malaysia's Glove Industry in Meeting Today's healthcare Challenges
    (Paper presented at the Latex 2001 Conference Munich Germany 4-5 Dec 2001)