|
|
Natural Rubber Latex Gloves
- Made from a Renewable Resource
Natural rubber (NR) latex gloves are natural products. They are derived
from NR latex obtained from the Hevea Brasiliensis tree when the bark
is tapped (Figure 1). This is unlike all synthetic gloves, which
are made from petrol chemicals.
|

|
| Figure 1.
Natural rubber latex collected in a cup after skillful tapping of the bark
of a Hevea Brasiliensis tree. |
|
>Raw NR Latex
This is a milky fluid comprising 25%-40% of rubber hydrocarbon in the
form of particles suspended in an aqueous serum together with a few percent
of other non-rubber substances such as proteins, lipids, carbohydrates,
sugars, some metals, fatty acids, and other substances, known as the non-rubber
fraction. The remaining major component is water.
|
|
>NR Latex Concentrate
Latex collected from the tree after tapping is concentrated generally
by centrifugation, to remove much of the aqueous components. The concentrated
latex with about 60% dry rubber content (or drc) is then usually preserved
with ammonia to combat bacterial growth. The resulting latex concentrate
becomes the starting material for all natural rubber latex products, whether
by dipping (for gloves, balloons, condoms, catheters, baby soothers, rubber
tubing, toys and dental dams) or other processes such as foaming (for
latex foam to sponge), or extrusion (for latex thread, more commonly known
as "elastic").
|
| Steps in the
Manufacturing Process |
|
>The manufacture of most NR
latex gloves follow roughly the same sequence. However, many manufacturers
include processing steps that reduce the level of protein in their gloves.
The typical glove manufacturing process is as follows:
|

|
| The salient
features of the above manufacturing processes include the following:
|
|
Dipping: Liquid latex
concentrate is mixed with various compounding chemicals and is introduced
into one of the tanks in the processing line. Clean, dry formers in the
shape of hands are immersed first in a coagulant and then in the latex
mix for appropriate dwell time to give the desired latex film thickness.
The coagulant is applied to facilitate the deposition of a layer of latex
on the formers.
|
|
Wet-gel leaching and beading:
The thin latex film on each former is partially dried and leached briefly
in clean water to remove the water-soluble materials. Beading also is
introduced at this stage to give each glove a rolled bead or rim at the
open end.
|
|
Drying and curing: The
gloves are then dried and vulcanized. Drying and vulcanization or curing
of the gloves are usually done in hot-air ovens, initially at lower temperatures
of 80º-90º C, and then at higher temperatures of 100º-140º
C where necessary.
|
|
Post-cure leaching or dry-film
leaching: The cured gloves are immersed in clean water tanks to remove
more water-soluble substances, particularly proteins on the surface of
the gloves.
|
|
Powdered gloves: The
leached gloves are dipped into cornstarch powder slurry to pick up a coat
of lubricant that makes them easier to don. They are then further dried.
|
|
Glove stripping: This
is the final operation on the production line - removal of gloves from
the formers. This is often carried out manually, frequently with the assistance
of compressed air, but an automatic stripping system is becoming more
common.
|
|
Powder-free gloves:
Latex gloves with very little or no powder lubricant can be prepared by
either (i) chlorination or (ii) polymer coating. While chlorination oxidizes
the outer rubber surface to eliminate tackiness and reduce the residual
soluble protein content, polymer coating involves replacing powder with
a suitable lubricating coat on the glove surface. Both processes can be
carried out on-line, without the powder-coating step, or off-line by washing
first the finished powdered gloves, then subjecting them to the chlorination
or polymer-coating treatment.
|
|
Removing Glove Proteins
Protein Status in Latex
|
When subjected
to ultracentrifugation at approximately 59,000 gmax, latex can be separated
into three main fractions: (i) top rubber hydrocarbon fraction, (ii) the
ambient serum (known as C-serum) in which all rubber particles are suspended,
and (iii) the denser bottom non-rubber particle fraction, particularly lutoids,
which contain yet another serum (known as B-serum). |
Yip
E. & Cacioli P, The manufacture of gloves from natural rubber latex,
J. Allergy Clin. Immunol., 2002; 110: S3-14
Like all plant materials, Hevea
latex contains proteins. Of the approximately 1% of total proteins present
in the latex system, about one-quarter are found on rubber particle surfaces
(i), the remaining three-quarters are in the non-rubber phase [fractions
(ii) and (iii)] of the latex, and they are mostly water soluble (Figure
3).
|

|
| Figure 3.
Freshly collected Hevea Brasiliensis latex separated into its three main
fractions upon ultra centrifugation at 59,000 gmax. |
|
When processed into latex concentrate,
considerable amounts of the soluble proteins are removed. Further conversion
of the latex concentrate into gloves removes more of these proteins through
the leaching and washing steps. Therefore, the remaining levels of soluble
proteins - or the residual extractable proteins implicated in allergic
reactions - are markedly low. Depending on which manufacturing process
is used, the level of residual extractable protein can vary widely.
|
Dalrymple
S.J. and Audley G.B. "Allergenic proteins in dipped products: Factors
influencing extractable protein levels," Rubber Developments, 1992; 45(2/3):51
Yunginger
J.W., Jones R.T., Fransway A.F., et al. "Extractable proteins in disposable
medical gloves and other rubber products," J. Allergy Clin. Immunol. 1994;
93: 836-842)
Ng
K.P, Yip E., Mok K.L. "Production of Natural Rubber Latex Gloves with
Low Extractable Protein Content: Some Practical Recommendations," J. nat.
Rubber Research, 1194; 9:87-95.
|
|
Latex Allergens
Not all proteins in the residual extractable fraction cause the allergic
reaction. Although to date 13 proteins (mostly soluble) in raw Hevea latex
have been reported to be possible allergens as defined by their display
of IgE antibody binding activities, it is unlikely that all of them would
be present in the finished products after processing.
- Alenius
H., Turjanmaa K. and Palosuo T. "Natural rubber latex allergy," Occup.
Environ, Med, 2002; 59: 419-424;
- Yeang
H.Y. "Natural rubber latex allergens: New developments," Curr Opin Allergy
Clin. Immunol. 2004; 4: 99-104),
Cross Reactivity
It is noteworthy that individuals with sera showing binding of IgE to
latex proteins are not necessarily latex allergic. The binding could be
due to cross-reactivity with other plant proteins with certain similarities,
suggesting shared or common antigenic components among proteins from latex
and foods. A study of binding patterns of IgE antibodies from the sera
of individuals who were not latex allergic but who had reactions to fruits
supported this. The findings also showed that multiple bindings occurred
between latex serum proteins and IgE from many who reacted to extracts
of fruits but not to latex gloves. On the other hand, more specific and
fewer bindings to latex protein by those who skin tested positive to latex
glove extracts were generally observed.
- Hasma
H., Shahnaz M., Yip E., Azizsah M., Mok K.L. and Nasuruddin B.A. "Binding
Patterns of IgE Antibodies in Sera of Rubber Tappers to Fresh Hevea
Latex Serum Proteins," J. Rubber Research, 1998; 1(3): 146-153
|
|
Allergenicity of Latex Gloves
The allergenic potential of latex gloves can be measured in-vivo by skin-prick
testing (SPT) on latex-allergic subjects, or in-vitro by specific IgE
antibody-inhibition immunoassays. The SPT method is known to be more specific
and more sensitive than the IgE binding techniques. However, all of these
methods are relatively sophisticated, and require further improvements,
and they are also expensive to perform.
The presently preferred method is the quantification of total proteins
using the modified Lowry micro-assay, which is technically easy and possible
to standardize as well as cost effective. However, the test is not allergen
specific. Nevertheless, significant correlations between residual total
extractable protein content and the allergen levels of extracts of NR
latex gloves based on both serological IgE specific inhibition immunoassays,
and the SPT testing, have been established. Latex gloves with high residual
extractable protein contents are associated with positive SPT or high
allergen contents. Latex gloves with very low residual extractable proteins,
on the other hand, tend to have very low or negligible SPT reactions by
latex sensitive subjects.
|

|
| Figure 4.
Total extractable protein content (as measured by modified Lowry assay)
of latex gloves and percentage negative skin prick test response shown by
latex sensitive subjects. (Ref: Yip E., Turjanmaa K., Ng K.P. and Mok K.L.
"Residual extractable proteins and allergenicity of natural rubber products,"
J. nat. Rubber Research, 1994; 9: 79-86;) |

|
| Figure 5.
Total extractable protein content and allergen level of 46 lots of latex
gloves, as determined by modified Lowry test and IgE latex specific ELISA-inhibition
respectively. (Ref: Yip E., Palosuo T., Alenius H., and Turjanmaa K. "Correlations
between total extractable proteins and allergen levels of natural rubber
latex gloves," J. nat. Rubber Research, 1997; 12: 120-130) |
This method, although non-allergen specific, offers a technically easy and
standardizable method that is very helpful in product developments and improvements.
-
Yip E., Turjanmaa K., Ng K.P. and Mok K.L. "Residual Extractable Proteins
and Allergenicity of Natural Rubber Products," J. nat. Rubber Research,
1994; 9: 79-86;
-
Yip E., Palosuo T., Alenius H., and Turjanmaa K. "Correlation Between
Total Extractable Proteins and Allergen Levels of Natural Rubber Latex
Gloves," J. nat. Rubber Research, 1997; 12: 120-130;
- Palosuo
T., Makinen-Kiljunen S., Alenius H., Reunala T., Yip E. and Turjanmaa
K. "Measurement of natural rubber latex allergen levels in medical gloves
by allergen-specific IgE-ELISA-inhibition, RAST inhibition, and skin
prick test," Allergy, 1998; 53: 59-67;
- Beezhold
D., Pugh B., Liss G. and Sussman G. "Correlation of protein levels with
skin prick test reactions in patients allergic to latex," J. Allergy
Clin. Immunol., 1998; 98: 1097-1162;
- Yip
E. and Sussman G. L. "Allergenicity of latex gloves with reference to
protein sensitive individuals in a Canadian population," J. nat. Rubber
Research, 2000; 3: 129-141.
Protein Reduction - Product
Improvement
Residual extractable protein content of gloves can now be reduced from
as high as 1,000-2,000 µg/g of gloves to a low of less than 50 µg/g
using improved manufacturing technologies, which include:
- Use of low-protein latex
concentrates
- Proper leaching protocols
- Chemical or enzymatic deproteinization
- Chlorination
- Polymer-coating
For more information, click here to review:
|
| |
| Close
this window. |