|
| Association for
the Advancement of Medical Instrumentation. This organization
is composed of a number of specialized task forces, with volunteer
experts from government, industry and academia, that develop standards
and guidelines as needed. Safeskin uses AAMI Method 1 ("Dose
Setting Using Bioburden Information") to determine the dose
for our sterile product, sterilized to a sterilization assurance
level (SAL) of 10-6. |
| A cavity filled
with pus (dead white blood cells and broken down tissues) and
surrounded by inflamed tissue. Sterile abscesses are caused by
a non-bacterial inflammatory response which may occur in acute
or chronic inflammatory conditions. |
| A glove donning
powder consisting of modified (cross-linked) cornstarch and less
than 2% magnesium oxide as defined in the United States Pharmacopeia
(USP). Phosphorous oxychloride or epichlorhydrin are utilized
in the surface cross-linking. This process is performed to make
the starch particle more resistant to breakdown during steam sterilization
and when immersed in sweat from the hands. In fact, the USP requires
that the powder must be capable of withstanding 20 minutes of
boiling without disintegrating. Thus, the end product is not readily
dissolved. |
| Pull within the
material (e.g. a sponge absorbs). |
| A chemical used
as a catalyst to accelerate the cross-linking of liquid latex
into a usable solid film. Primary accelerators used for making
gloves are thiazoles (MBTs), thiurams, carbamates and thioureas.
Accelerators are known to be contact sensitizers. |
| Transformed cells
that have achieved the capacity to exercise their full functional
potential (e.g. activated macrophages, T-cells and mast cells).
They activate, or turn on, when something in the environment triggers
their need. For example: endotoxin, foreign bodies and inflammation
activate macrophages; chemical contact sensitizers activate T-cells,
etc. |
| Adhere to the surface
of a material (e.g. salt adsorbs to the surface of popcorn). |
| That which can
cause an allergy (Type I or Type IV hypersensitivity). However,
allergen is more commonly used when referring to a substance,
usually a protein, that is able to elicit an IgE antibody response
and activate mast cells. Every allergen is a type of antigen but
not every antigen is an allergen. |
| An allergic rash
(Type IV) with physiological memory to the chemical sensitizer
which caused it (meaning it will cause it again with subsequent
exposure). |
| The immunologic
state induced in a susceptible individual by an allergen characterized
by a marked change in the subject’s reactivity. Both Type
I and Type IV hypersensitivities are allergies (e.g. Type I =
latex protein allergy, hay fever, penicillin allergy; Type IV
= chemical accelerators, nickel, poison oak). |
| An immediate systemic
allergic reaction to a foreign protein or other substance. The
reaction results from the release of histamine and other substances
when allergen combines with IgE antibodies on mast cell surfaces.
There are receptor sites for histamine on the surface of blood
vessels. When triggered, the vessels dilate, letting fluid (not
red blood cells) leak out into the surrounding area. This can
be local, as seen in the raised surface of a hive, or it may be
systemic. If the release of fluids from the circulatory system
is systemic, the lost volume results in hypotension (drop in blood
pressure). The heart increases its speed to compensate (tachycardia).
If sufficiently severe, it can lead to anaphylactic shock and,
rarely, death. |
| Circumscibed swelling.
In Type I reactions, swelling of the lips and periorbital (around
the eyes) often occurs. |
| American National
Standards Institute. ANSI endorses standards and guidelines for
the U.S. but does not actively create them. |
| A substance formed
in the body that reacts specifically with an antigen. The antigen
may be a protein or allergen that causes Type I hypersensitivity
(IgE) or other antigens to induce resistance to infection (IgA,
IgD, IgE, IgG, IgM). The Ig stands for immunoglobulin and the
A, D, E, G, and M are the categories of antibodies, each serving
a slightly different function. |
| Any substance that
is capable of eliciting an immune (antibody or cellular) response;
a molecule that causes the creation of and subsequently combines
with the antibody or antigen-specific receptor on a T-cell. Both
thiuram (Type IV contact sensitizer) and natural rubber latex
proteins (Type I allergen) are antigens. |
| Chemical contact
sensitizers that can elevate the level of sensitization for patient
and healthcare provider, potentially resulting in allergic contact
dermatitis (Type IV, delayed type hypersensitivity) externally
or granulomas internally. |
| A substance added
to latex and synthetic gloves to prevent or delay deterioration
of the glove by the oxygen in air. |
| A condition of
the lungs in which there is widespread narrowing of the airways.
Most cases represent a chronic form of allergy due to IgE antibodies.
Irritant asthma is activated by irritants such as a chemicals
or particles. |
| American Society
of Testing and Materials. The ASTM issues testing standards and
specifications. The FDA utilizes many of the standards developed
by ASTM to establish medical device requirements. |
| Without symptoms.
An asymptomatic individual does not display reactions. |
| A person with a
hereditary tendency to develop IgE-mediated hypersensitivity,
usually having multiple allergies to substances such as ragweed,
cat dander, dust mites, pollens and foods. |
| A hereditary tendency
to develop IgE-mediated states of hypersensitivity, such as hay
fever. |
|
|
| A cell in the bloodstream
functioning in a similar manner as mast cells, which reside in
the tissues. See . IgE antibodies can attach to its outer surface. |
| The total number
of viable bacteria and fungi on a packaged item prior to irradiation.
Safeskin uses TIR8 "Microbial Methods for Gamma Irradiation
Sterilization of Medical Devices" from the AAMI guidelines. |
| Responsible for
the production of immunoglobulins (antibodies) of all types: IgA,
IgD, IgE, IgG, IgM. As the B-cell is activated or transformed
and begins production of antibodies, it becomes known as a plasma
cell. |
|
|
| A mold-release
agent often used to facilitate the release of latex gloves from
their porcelain molds (formers). Calcium carbonate is a non water-soluble
crystal. It occurs in nature as oyster shells, chalk and limestone.
The chlorination process utilized to produce powder-free gloves
removes the calcium carbonate. |
| Within a well-defined
area or in one with definite boundaries or limits. A hive has
a circumscribed region of swelling. |
| A chemical agent
used in the manufacturing process of latex rubber that may elicit
a delayed type allergic reaction (Type IV) after repeatedly exposing
the substance to a susceptible individual. The Type IV reaction
is usually triggered when the contact sensitizer dissolves in
perspiration and is absorbed through the epidermis. Symptoms usually
decrease with time after removal of the sensitizer. The most common
latex-related contact sensitizers are accelerators such as thiurams,
mercaptobenzothiazole (MBT) and carbamates. Other chemical additives
(antioxidants, preservatives, etc.) have been reported as possible
contact sensitizers, for example Butylhydroxyanisol (BHA) and
3,5-di-tertiary butyl 4-hydroxytoluene (BHT), 4,4-thiobis (6-tertiary
butyl) meta cresol (Lowinox 44S36) and amine derivatives IPPD,
CPPD, DPPD. |
| Contact urticaria
or hives may appear within minutes to an hour after a sensitized
individual comes in contact with allergens to which he/she is
allergic. It is usually a Type I hypersensitivity reaction. |
| Antigens that differ
from one another but are similar enough that they can react with
antibodies raised against either one of them. Cross-reactive proteins
that may combine with latex IgE antibodies include: |
|
apple
|
figs
|
peach
|
|
apricot
|
grape
|
pear
|
|
avocado
|
hazelnut
|
pineapple
|
|
banana
|
kiwi
|
plum
|
|
buckwheat
|
mango
|
potato
|
|
carrot
|
melon
|
ragweed
|
|
celery
|
mugwort
|
rye
|
|
cherry
|
nectarine
|
timothy grass
|
|
chestnut
|
orchard grass
|
tomato
|
|
date
|
papaya
|
wheat
|
|
ficus (benjamina tree)
|
passion fruit
|
|
|
| Cytokines are chemicals,
released from cells, that signal other cells to the area, activate
specific cell types, "turn off" cells and regulate other
activities as needed. |
| Injures cells.
Demonstrated using tests such as hemolysis, medium eluate method
(MEM), agar overlay and embryo toxicity. |
|
|
| Deleterious effects
that liquid chemicals, extreme heat, ozone, fatigue, oil or other
substances have on the physical properties of gloves. Tell-tale
signs of degradation may include softening and tackiness, brittleness,
loss of elasticity, growth or creep at the fingertips. |
| The expulsion of
granules from a sensitized mast cell when triggered by an allergen
(Type I reaction). Granules include stored substances such as
histamines. The cells then re-synthesize new stores of mediators
and continue their patrol. |
| Initiated by antigenic
chemicals (chemical contact sensitizers) on the skin, this delayed
hypersensitivity causes the symptoms of allergic contact dermatitis
such as itching, red appearance; small blisters; dry, thickened
skin; crusting; scabbing sores; papules; peeling and vesicles.
In the wound, symptoms include granulomas and adhesions as well
as tissue, skin graft, implant and transplant rejections. |
| A general term
referring to any inflammation of the skin; may be caused by irritation
or Type IV (delayed type hypersensitivity). Characterized by erythema
(redness), pain, pruritus (itching), vesicles (tiny blisters)
and papules (hard bumps). If the dermatitis continues to occur
for a long period of time (becomes chronic), symptoms may expand
to include drying, scaling, peeling and keratosis (thickening
and hardening of the skin). |
| The maximum radiation
dose that can be delivered to a product before unacceptable damage
occurs. |
| The minimal radiation
dose required to sterilize the product to the desired sterilization
assurance level (SAL). |
| An enzyme that
breaks down DNA. If it is present on standard gloves, additional
processing is required for its removal. DNAse should be considered
when running laboratory DNA isolation, purification and characterization
studies. |
| A set of procedures
performed to ensure the dose is still correct. The population
and sterilization resistance of microorganisms vary with environmental
conditions such as temperature and moisture. Thus, verification
of the appropriateness of the sterilizing dose is performed quarterly
as a dose audit. |
| A study performed
to determine where maximum and minimum radiation hits Safeskin
products when sterilized. Dose mapping must be repeated whenever
the glove, packaging box density, loading configuration or the
sterilizing energy source changes so that the radiation penetration
profile may be altered. |
| Method 1, "Dose
Setting Using Bioburden Information." Determine the number
of organisms on the packaged, pre-sterilized gloves. This is followed
by irradiation with a dose taken from a table in the AAMI manual
calculated to kill 90% of that number of microorganisms. If this
sub-lethal dose actually kills at least 90% of the micro-organisms,
the standard radiation dose is verified as adequate. |
| A device that measures
the amount of radiation which reaches the position where the dosimeter
is placed. |
| 200-person challenge
test utilized to determine irritant or dermal reactions caused
by chemicals of a given product. Samples of the test glove are
patch tested repeatedly on each of the individuals over a 6-week
period. |
| A condition of
dermal breakdown (irritation) aggravated by constant, long-term
contact with sweat in an occlusive environment, as under a glove
without frequent changing. Vesicles, or tiny blisters, which are
very painful often appear. This is most frequently seen in factory,
cleanroom (e.g. semiconductor) and custodial employees. |
| Difficulty breathing;
shortness of breath. |
|
|
| Dermatitis of the
skin, often of unknown origin, marked early by redness, itching,
minute papules and vesicles, weeping, oozing and crusting; and
later by scaling, thickening and hardening of the skin. Causes
may be allergic or non-allergic. Atopic individuals often have
had periods in their life when they had breakouts of eczema on
the hands, legs, inside of the elbows or behind their knees. |
| Swelling. |
| A measurement in
percent of the length a glove material can be stretched before
it breaks. |
| Physiologic response
resulting from a high dose of endotoxins into the blood stream.
There is a sudden outflow of fluid from the blood vessels resulting
in blood pressure drop (hypotension) which can cause the body
to go into shock due to lack of sufficient oxygen supply to the
tissues. |
| Pieces of the cell
wall of dead gram negative bacteria, capable of causing multiple
local and systemic pathological consequences, including fever,
complement activation, cell lysis, tissue inflammation, diarrhea,
microthrombi formation (clots), disseminated intravascular coagulation
(DIC) and endotoxic shock. In a laboratory context, endotoxin
can interfere with complement assay, cellular immunoassays and
tissue or cell culture studies. |
|
| A highly sensitive
immunoassay for specific antibodies or antigens (including allergens)
depending on how the test is set up. Results expressed as microgram
per gram or milliliter (µg/g or mL); parts per million (ppm);
allergen units per gram or milliliter (Au/g or mL). |
| Inflammatory redness
of the skin. |
|
|
| Horizontal cracks
in the skin most notable in irritation reactions. |
| A diffuse area
of redness on the skin due to increased dilation of the local
blood vessels. Flares are usually present surrounding the wheals
of a hive, projecting outward like rays. |
| Inanimate materials
or objects potentially transmitting or carrying infectious agents
from one infected person or contaminated item to another person
or item. A recently used nose tissue is a fomite. |
|
|
| This describes
an individual with the DNA capability to physiologically act in
a particular way. In the case of Type IV (delayed type hypersensitivity)
to specific chemicals in a glove, a genetically predisposed individual
is capable of forming receptor sites to that chemical on their
T-cells. In the case of immediate or Type I hypersensitivity,
a genetically predisposed individual is capable of producing IgE
antibodies to latex (or cross-reactive) proteins. |
| Calcified nodules
formed by the body as a protective, walling-off of foreign bodies
or chronic inflammatory conditions caused by long-term irritants,
infections or the presence of particles triggering a Type IV response.
Those resulting from powder contamination are characterized microscopically
by a Maltese cross design under polarized light. Granuloma nodules
may remain long after the starch particles at their centers dissolve. |
|
|
| A small biochemical
group that initially, by itself, cannot elicit an allergic response.
It must conjugate (join) to a carrier (usually protein) to be
recognized by the body. Once the body reacts to the two together,
it may recognize the hapten alone. |
| A highly vasoactive
(acts on the blood vessels) substance liberated in large amounts
from basophils and mast cells during allergic (immediate type
hypersensitivity - Type I) reactions. The release is triggered
when the allergen attaches to the IgE antibodies on the surface
of the cells. Histamine causes dilation of capillaries, a decrease
in blood pressure, increased secretion of gastric juice and constriction
of the small tubes (bronchü) in the lungs and uterus. |
| Above, higher than
normal, as in hyperactive, hypertension (high blood pressure)
or hypersensitivity. |
| Term used to describe
an exaggerated response to a substance (i.e. an antigen), developed
after repeated exposure, causing a genetically predisposed individual
to become sensitized or allergic (Type I or Type IV). |
| Below, under, deficient,
containing less than usual such as in hypodermic, hypotension
(low blood pressure). |
| As a term for gloves,
the claim hypoallergenic was developed to describe a reduced potential
for developing a dermatological response to chemicals utilized
in production of a given product. The 200-person Modified Draize
test is used to determine potential for irritancy or allergic
contact dermatitis (Type IV) to the product.
After producing product to meet these requirements, manufacturers
were allowed to utilize the term hypoallergenic as an identifier
for the product (a claim). However, in recent years individuals
have also developed Type I allergic reactions in association
with the proteins in gloves. Because the label claim of hypoallergenic
was being interpreted to refer to both Type IV (chemicals) and
Type I (protein) allergies, rather than just Type IV, this claim
was removed from all gloves September 30, 1998.
|
|
|
| An adverse patient
condition caused by the treatment or diagnostic procedures. An
iatrogenic disorder is a condition caused by medical personnel
or procedures or through exposure to the environment of a health-care
facility. |
| Hardness, caused
by inflammatory swelling with excessive number of white blood
cells. |
| Antibodies (immunoglobulin)
of any of the five classes: IgA, IgD, IgE, IgG and IgM. |
| Immunoglobulin
E (IgE Antibodies). IgE antibodies are the hallmark of a Type
I allergy (e.g. penicillin, peanut, latex protein). Antibody that
is made after contact with an allergen in genetically capable
individuals. Once made, IgE antibodies attach to mast cells (in
tissues) and basophil cells (in blood) and mediate immediate type
hypersensitivity reactions (Type I). |
| Attaches to foreign
bodies as well as bacteria to incapacitate and assist in their
destruction. These are the antibodies created when individuals
are inoculated with vaccines. |
| Multiplication
of organisms in the body that may or may not result in disease. |
| Cellular or systemic
response to physiological, chemical or biologic injury. Inflammation
occurs as a part of irritation, Type I and Type IV reactions.
An extremely dynamic pathological process in which the blood vessels
dilate, releasing fluids to the local area. Leukocytes, or white
blood cells (WBC) enter, releasing destructive enzymes in their
attempt to clean the debris of dead cells. These enzymes cause
tissue damage further increasing the inflammation and depleting
these cells of their defense weaponry (enzymes). In so doing,
they decrease the local area’s resistance to infection. If
the body cannot rid itself of the inflammatory agents, a more
chronic inflammatory condition sets in. The body tries to wall
off the culprits, to protect the rest of the body, by such mechanisms
as forming granulomas and adhesions.
Four fundamental signs of inflammation are: redness, heat,
swelling and pain; a fifth, loss of function, is sometimes present.
|
| Dermatitis develops
when a substance repeatedly chemically injures, physically abrades
or otherwise damages the skin. |
| An inflammatory
reaction of tissues to an injury. An irritation is not an allergic
response, it possesses no physiological memory of the substance
that caused it. Repeated contact or long-term exposure can result
in irritant contact dermatitis on the skin or chronic inflammation
in a surgical wound, potentially developing into granulomas or
adhesions. |
|
|
| The International
System of Units (SI) for absorbed dose where 1 gray (Gy) equals
1 joule per kilogram. This measurement of the amount of radiation
exposure was formerly expressed in megarads (Mrad) where 1kGy
= 10-1 Mrad (e.g. 2.5 Mrad would now be termed 25 kGy). |
|
|
| The general definition
is a colloidal suspension in an aqueous fluid. More commonly,
it is the milky, usually whitish fluid obtained from over 1,000
species of trees and plants. Relating to gloves, it is natural
rubber latex, the raw material from the Hevea brasiliensis
tree. It contains poly-cis-isoprene, the "rubbery" component
of latex products. The latex liquid also contains the proteins
(allergens) to which latex allergic (Type I) individuals may react. |
| Process in the
production of gloves by which chemicals or contaminants are dissolved
and carried away by water. Wet gel leaching occurs right after
latex is dipped onto the mold. It is still in its gelled state.
Dry gel leaching occurs after gloves pass through ovens transforming
them from a gel to a solid, rugged film. When gloves are dry gel
leached before the application of powder, their proteins may be
reduced by 80-90%. |
| Latex ELISA Antigenic
Protein assay. An ELISA utilizing rabbit IgG antibodies made to
latex proteins. The advantages include specificity for latex proteins
and a heightened sensitivity or detection capability over the
Modified Lowry assay for total protein. The disadvantage of this
assay is that the latex protein allergens measured are those recognized
by rabbit IgG antibodies and may or may not be recognized by human
IgE. |
White blood cells,
the body’s major cellular defense system. These cells include:
- Neutrophils (a.k.a. polymorphonucleophils [PMNs]): phagocytic
cells. Usually the first defensive cells to the site of injury,
engulf, destroy and digest the offending agents. PMNs are
"sloppy," leaking digestive enzymes into the surrounding
tissues potentially injuring the host (person). Dead PMNs
are the primary components of pus.
- B-cells: Specialized lymphocytes which produce the various
antibodies, including IgE. Antibody producing B-cells are
plasma cells.
- T-cells: Specialized group of lymphocytes. They include:
- T-helper (Th) cells which assist B-cells in producing
antibodies
- T-suppresser (Ts) cells which suppress immunological
activity to avoid over reaction
- T-cells (Tc) which release cytokines (chemical
signals) and assist phagocytes
- T-killer (Tk) cells which recognize and destroy
cancerous cells and cells infected with virus
- Macrophage: Versatile phagocytic cells, orchestrating much
of the body’s immunological activity. Digestion of infectious
agents is neat and self-contained (compared to PMNs –
neutrophils – that are sloppy and release enzymes onto
healthy tissues as well as on the entity they are trying to
destroy).
- Mast cells: Specialized tissue cells rich in vasoactive
substances such as histamine; resemble basophils in form and
function. Mast cells carry receptors for IgE antibodies and,
together with basophils, participate in immediate type hypersensitivity
(Type I) reactions by releasing histamine and other stored
mediators when the IgE antibodies they are carrying come in
contact with the allergens they recognize (e.g. latex protein,
avocados or bananas). Mast cells reside primarily in the tissues;
basophils in the blood stream.
- Eosinophils: Cells that travel to the sites of immediate
type hypersensitivity (Type I) reactions where they modulate
mast cell degranulation, attempting to reduce over-reaction.
|
| Thickening and
hardening of the skin with exaggeration of its normal markings,
like lines and creases, resembling elephant skin in appearance. |
| A test method used
to determine the concentration of total protein present in a sample.
A Modified Lowry assay was developed for use with latex products.
In the Modified Lowry assay (ASTM D5712), latex proteins are extracted
from products and purified by acid precipitation. This step diminishes
the chemicals present in the product that may interfere with the
assay. A protein detection agent is then added that increases
in color intensity with increasing amounts of protein. Results
are expressed as micrograms (µg) of total protein extracted or
microgram per gram (µg/g) of sample. The greater the number, the
greater the amount of protein present. This is the only method
currently accepted by the government for the measure of protein
level in latex products. The amount of protein on a glove generally
correlates with the amount of allergen (the proteins people react
to). However, not all latex proteins are allergens. |
| A white blood cell,
either B-cell or T-cell. |
| A soluble chemical
released by sensitized lymphocytes on contact with a specific
antigen. Lymphokines help stimulate the activity of other lymphocytes
and macrophages. Lymphokines are specific forms of cytokines. |
| Ruptured or broken
open as in lysed red blood cells during the hemolysis test. |
|
|
| Softening of tissues
by the action of a liquid, making it more vulnerable to abrasive
injury. Hands can become macerated after hours of sweating under
a glove, potentially resulting in irritant contact dermatitis.
For workers who wear the same gloves (without removal) for hours
at a time, day after day, an exaggerated or chronic form of maceration
may develop with an extensive rash and painful vesicles. This
condition is known as dyshydrosis. Individuals at risk include
those working in cleanroom industries (e.g. semiconductors, pharmaceuticals)
and in hospital housekeeping. |
| A very fine, white,
odorless powder added to modified cornstarch to prevent caking
in the production of USP absorbable dusting powder. No more than
2% is allowed. |
| Mast cells are
white blood cells residing primarily in the tissue that carry
receptors for IgE. Together with basophils, they participate in
immediate type hypersensitivity (Type I) reactions by releasing
stored histamine and other vasoactive substances on contact with
the specific allergen that their attached IgE antibodies recognize. |
| Substances that
incite, initiate or control such reactions as inflammation, white
cell activation or the progress of an allergic reaction. |
| A birth defect
of the spinal column, characterized by the absence of vertebral
arches (top part of the backbone), through which the spinal membranes
may protrude. Thus, this portion of the central nervous system
is not adequately protected. Problems experienced by the individual
depend on where and how severe the defect is. They may have problems
with their legs, urinary tract, etc. For reasons not totally understood,
patients with Spina Bifida are at extremely high risk of developing
latex-related hypersensitivity. |
| See Lowry.
|
| A measurement of
the resistance to stretch. A lower modulus represents a glove
in which it is easier to move and thus less fatiguing. |
|
|
| See leukocytes. |
| Non-fever causing.
Reflects low levels of endotoxins which cause fever, inflammation,
endotoxic shock and elicit micro-thrombi formation and numerous
other adverse conditions. (see ) |
| Infection acquired
in a hospital. Nosocomial diseases may be acquired by patients,
visitors or hospital staff. |
|
|
| An extremely reactive
gas (O3) that is produced by the interaction of oxygen
and an energy source. Generators, fans, electrocautery units,
X-ray machines, etc. produce ozone when running. Ozone exposure
can lead to deterioration of latex and most synthetic gloves. |
|
|
| Small circumscribed,
solid, elevated bumps in the skin. Scratching them is usually
painful. |
| Movement of chemical
through a glove on a molecular level. Data displaying permeation
values represent breakthrough times when the glove is under continuous
contact with the test chemical. |
| Hydrogen ion concentration;
measurement of how acidic or basic a solution is. |
| Cells that engulf
or take in substances that the body is trying to get rid of, including
bacteria, fungi, foreign bodies (e.g. asbestos) and dead cell
or tissue debris. |
| The ability of
a cell to engulf and take in foreign bodies or microorganisms.
Phagocytic cells include macrophages and neutrophils (PMNs). |
| Donning powder
on gloves is composed of cornstarch (USP absorbable dusting powder).
Some companies have qualified a lactose starch. Powder facilitates
donning and absorbs sweat. Studies have shown powder to function
as abrasive particles, immunological activators, and possibly
as vehicles for the dissemination of chemicals, proteins and microorganisms.
Powder has been implicated in lowering of resistance to infection.
It also has been shown to interfere with wound healing processes,
increasing the risk for incremental complications in OR and post-operative
care. |
| An enzyme that
breaks down proteins. Present on standard gloves to varying levels,
additional processing is required for its removal. Should be considered
when using gloves during laboratory protein isolation and characterization
studies. |
| Regarding latex
gloves, protein content is the measurement of total protein regardless
of allergenic content. The ASTM D5712 Modified Lowry assay is
the method recognized by the government for use with gloves. Protein
allergens may elicit Type I, immediate type hypersensitivity by
initiating the production of IgE antibodies (that attach to mast
cells). In genetically predisposed individuals, these antibodies
will recognize and react with the same or similar proteins (cross-reactive
proteins) in subsequent exposures. Repeated exposure to the protein
allergens (or look-a-like cross-reactive allergens) through dermal,
mucosal, pulmonary or invasive routes, asymptomatically (without
experiencing symptoms) increases the number of sensitized mast
and basophil cells until a clinical threshold is reached. Once
this critical threshold is attained, symptoms may occur including
urticaria, rhinitis, dyspnea, abdominal cramps, headache, hypotension,
tachycardia and rarely anaphylactic shock. Gloves lower in protein
content are expected to reduce the risk of developing a Type I
hypersensitivity (allergy). |
| Any of a class
of naturally occurring complex combinations of amino acids (containing
carbon, hydrogen, oxygen, nitrogen, usually sulfur, occasionally
phosphorus) that are essential constituents of all living cells.
Proteins are responsible for the growth and maintenance of all
tissue. Some individuals mount an excessive IgE immunological
response (allergy) when exposed to specific proteins (or similar,
cross-reactive proteins). They have developed a Type I hypersensitivity
to these proteins (also termed allergens). |
| A "creamy"
liquid that consists of the remains of dead white blood cells
and tissue debris. Its main constituent is an abundance of polymorphonuclear
cells (PMN - aka neutrophile). |
| A fever producing
substance. Endotoxin is a pyrogen. |
| Capable of eliciting
a fever. |
|
|
| A radioimmunoassay
designed to detect IgE-bound allergens responsible for tissue
hypersensitivity. The protein allergen is bound to a surface such
as plastic plates or spheres. The patient’s serum is added.
If the serum contains antibody to the allergen, the antibodies
will attach to the allergen. The level of attachment is measured
and the amount quantified. The test may be designed the other
way, where the IgE antibodies are placed on the surface. Then
an extract of the product, such as a glove, is added to the test
to determine if allergens are present. |
| Inflammation of
the nasal mucous membrane (runny nose). |
| An enzyme that
breaks down RNA. Present on standard gloves, additional processing
is required for its removal. It is more ubiquitous than DNAse
and thus more difficult to avoid. Should be considered in laboratory
situations when isolating, purifying or characterizing RNA. |
| An elastic substance
obtained from the latex of many tropical plants, especially Hevea
brasiliensis (rubber tree). It is present in over 40,000 products
in the medical and consumer industry. The term rubber more generally
applies to products made from coagulated, compressed, crumbed
or dried latex. Products manufactured by dipping or extruding,
in which the latex is not solidified prior to processing, are
more technically termed latex products. Under this definition,
"rubber" products generally have lower extractable protein
levels than "latex" products. |
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| The expected probability
of an item being non-sterile after exposure to a valid sterilization
process. SAL’s normally range from 10-3 (1 in
a thousand) to 10-6 (1 in a million). Safeskin sterile
gloves are sterilized to a SAL 10-6. |
| The level of radiation
delivered to the product to achieve the required SAL. |
| The physiological
process of developing an allergy. |
| To increase the
specific sensitivity of an individual to an antigen or allergen
as the result of exposure. Sensitization is an asymptomatic process
until an individual's threshold level is reached. This requires repeat(ed)
exposure to the antigen or allergen. Subsequent exposure may elicit
symptoms. |
| A limited defect
in the spinal column, characterized by the absence of vertebral
arches, through which the spinal membranes may protrude. Patients
with Spina Bifida are at extremely high risk of latex-related
hypersensitivity. (See Meningomyelocele) |
| Assurance that
a given device is without living organisms. The sterility assurance
level (SAL) accepted by the United States (Association for the
Advancement of Medical Instrumentation - AAMI) is generally 10-6
(a probability of one non-sterile unit per million tested). |
| The expected probability
of an item being non-sterile after exposure to a valid sterilization
process. SAL’s normally range from 10-3 (1 in
a thousand) to 10-6 (1 in a million). Safeskin sterile
gloves are sterilized to an SAL of 10-6. |
| Not of natural
origin; produced by chemical synthesis. Synthetic gloves include,
but are not limited to, vinyl (PVC), neoprene (chloroprene), nitrile,
viton (fluorocarbon rubber), styrene butadiene (SBR), Tactylon*
(Styrene-Ethylene- Butylene-Styrene—SEBS) and polyethylene. |
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| Rapid heart rate. |
| Magnesium silicate,
Mg3Si4O10(OH)2, is
used as a solid lubricant. It was banned from use on surgical
gloves after it was found to cause granulomas and adhesions in
surgical wounds. The body treated the talc granules as foreign
bodies that needed to be walled off with fibrin and calcium (a.k.a.
granuloma), a mechanism of protecting the rest of the body from
the "invading foreign substance." |
| Measurement of
the amount of stretch or pull required to rupture or break the
glove material. |
| The lymphocyte
responsible for cell-mediated immunity. When sensitized, T-lymphocytes
have a receptor that recognizes a specific chemical antigen (chemical
sensitizer). On subsequent exposure to that chemical, the sensitized
T-cell releases lymphokines, which attract macrophages, neutrophils
and other white blood cells to the reaction site. Inflammation
ensues and can become chronic. This condition, Type IV hypersensitivity,
is also know as allergic contact dermatitis, delayed hypersensitivity
or chemical allergy. |
| An IgE-mediated
immediate hypersensitivity reaction. Symptoms may include, but
are not limited to, hives, itching, runny nose, watery eyes, facial
swelling, abdominal cramps, diarrhea, nausea, difficulty breathing,
rapid heart rate (tachycardia), sudden drop in blood pressure
(hypotension), dizziness and anaphylactic shock. Severe cases
may be fatal. Examples include Type I allergies to: penicillin,
avocados, bananas, peanuts, strawberries, bee stings and natural
rubber latex proteins. |
| A cell-mediated
delayed hypersensitivity reaction. It is characterized by
dermatitis, eczema, erythema, vesiculation (blisters), keratosis
(overgrowth and thickening of the skin), hyperplasty (thickening
of skin) and cracking. The area affected usually increases with
repeated exposure. Examples include Type IV allergies to: poison
oak, nickel, soaps and fragrances and chemicals such as accelerators
used in glove manufacturing (thiurams, thiazoles and carbamates). |
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| A method of infection
control in which all human blood, other bodily fluids and certain
other potentially infectious materials are considered infectious
for HIV, HBV and other bloodborne pathogens. It encompasses a
variety of practices to prevent occupational exposure, such as
the use of personal protective equipment, disposal of sharps in
sharps containers and housekeeping. |
| Hives. |
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| Substances that
act on blood vessels; for example, to dilate (expand), constrict
or alter blood vessel permeability. |
| A small circumscribed
elevation of the epidermis containing fluid; a small blister. |
| Usually refers
to polyvinyl chloride (PVC) resin used as a rubber substitute
in many medical and industrial applications. The material itself
is a barrier when just removed from the box. However, vinyl's
non-elastic properties render vinyl gloves less capable of maintenance
of barrier integrity after extended use, or in rigorous procedures
as compared to natural rubber latex. Thus, vinyl should not be
used where there is risk of contamination with infectious materials. |
| Measurement of
the amount of force necessary to propagate a tear. |
| The process of
treating crude latex and subjecting it to heat and sulphur to
render it non-sticky and increase its strength and elasticity. |
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| A circumscribed
swelling of the skin, appearing as an urticarial (hive) lesion;
slightly reddened, often blanched in the center, changing in size
and shape, extending to adjacent areas, and usually accompanied
by intense itching. It may be produced in Type I allergic individuals
when exposed to substances to which they are allergic. The wheal
is often surrounded by rays of swelling called flares. |
| The cells of the
immune system, also called leukocytes. They received the name
white cells because they compose the thin white layer that forms
between the red blood cells and the serum when the blood separates
into layers as it is spun in a centrifuge. White blood cells are
the body's major cellular defense system. See leukocytes. |