Glossary of Terms E-L
Contact Dermatitis and inflammation of the skin, marked initially by redness, itching, minute papules and vesicles, weeping, oozing and crusting; and later by scaling. This can develop into a thickening and hardening of the skin. Causes may be allergic or non allergic.
The measurement of the length a glove that can be stretched before it breaks. It is expressed as a percent of the original length of the glove at the moment it breaks. The higher the percent, the more stretchable the glove material.
Enzyme Linked Immunosorbent Assay(ELISA)
A highly sensitive immunoassay for specific antibodies or antigens (including allergens). Results are expressed in 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.
FDA 510(k) Number
Section 510(k) of the Food, Drug and Cosmetic Act requires that all device manufacturers must register to notify the FDA, at least 90 days in advance, of their intent to market any medical device. This is known as a Premarket Notification, and allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories (Class I, II, III). Devices are awarded specific numbers for each product. Major product modifications may require a new 510(k) number. Search FDA releasable 510(k) database at http://www.fda.gov/cdrh/510khome.html
The finished, cured or semi cured material made from suspended latex compound, used to form a glove.
The finish of a glove can provide better grip control in wet or dry applications. Patterns are cut directly onto the glove former, as it is cast, for embossed, sandblast or recessed diamond finish. For a bisque (matte) finish, the glove former is cast and then slightly roughened. For additional gripping power, some supported (heavy duty utility) gloves receive a textured wrinkle, applied rough particle, or embossed self flushing (tire or tractor tread) finish. Gloves with a smooth finish rely solely on the gripping qualities of the material itself.
A popular method of sterilization utilized in the healthcare industry which uses electromagnetic radiation (bombardment of high energy photons+gamma rays) as opposed to chemicals such as Ethylene Oxide.
A glove thickness is measured in gauge, mil or millimeter. Low gauge (thin) gloves provide more flexibility and sensitive touch, while higher gauge (thicker) gloves offer enhanced protection.
This is a term used to describe a heightened response to a substance (I.e. an antigen), that has developed after repeated exposure, and causes a genetically predisposed (atopic) individual to become sensitized or allergic (Type I or Type IV).
With regard to 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 irritancy or allergic contact dermatitis (Type IV) to the product. After manufacturing 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 from the gloves. Because the label claim of hypoallergenic was being interpreted as to refer to both Type IV and Type I allergies, rather that just Type IV, this claim was removed from all gloves September 30, 1998.
Industrial Grade Gloves
See B grade gloves.
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 may result in irritant contact dermatitis on the skin or chronic inflammation in a surgical wound, potentially developing into granulomas or adhesions.
A colorless, volatile liquid compound distilled from raw rubber or manufactured synthetically, which is used mainly to make synthetic rubber.
Natural Rubber Latex is a milky sap-like substance produced by the rubber tree called Hevea Brasiliensis, found in Southeast Asia, India and South America. When the trunks of these rubber trees are tapped, they produce latex. This latex is then collected and used in manufacturing. Natural Rubber Latex is harvested from the Hevea tree by a process of shallow cuts in the bark, called “Tapping”. Latex coagulates on exposure to air, so the tapped liquid is "preserved" with ammonia. Then the solids are separated, like cream from milk. The Latex used for medical examination and surgical gloves is filtered and combined with selected chemical ingredients to enhance elasticity, strength, durability, and resistance to damage from ozone and other ageing effects.
Containing NO natural rubber latex (e.g. nitrile, vinyl, neoprene, etc.).
The washing process, commonly used during the manufacturing of gloves, to remove or denature natural water soluble proteins and remove adverse materials such as processing chemical residues. Water or wet gel leaching is the process of immersing the latex coated formers into a bath or spray of water, to wash out excess additives from previous stages, such as coagulant. Chemical and protein content is reduced at this stage. The effectiveness of the process is dependent on the temperature of the water, the duration of the process and the rate of water exchange. Dry Film leaching is similar to wet film leaching, except it is carried out on the dry/vulcanized latex film. The effectiveness of this process in reducing water extractives is a function of time and temperature.
Latex, ELISA, Antigenic, Proteins (enzyme-linked immunosorbent) assays that use antibodies which are sensitive to latex proteins to quantitatively measure the level of antigenic proteins in latex extracts. The antibodies (IgG) are generated from rabbits that are immunized with purified latex protein. LEAP assay is not a valid measurement under ASTM or FDA guidelines.
Glove length is determined by the depth of hand/arm immersion in the solution and the extent of splash protection required. To protect the hand and wrist, select a glove 9-14” long (23-36cm). Elbow length, typically 14-18” (36-46 cm) protects the forearm. Shoulder length, about 31” (78cm) gives full arm protection.
Lining, a natural or synthetic fiber that covers the inside surface of an unsupported glove, and offers greater hand comfort by absorbing perspiration and providing easy donning and removal of glove.
Lowry Protein Assay
A test method to determine the concentration of total protein present in a sample. A modified Lowry was developed for use with Latex Products. This is the only method currently accepted by the FDA for the measure of protein levels in latex products.