Glossary of Terms C-D
A mold-release agent added in the beginning of the production cycle to help the release of gloves from the hand molds or formers. Calcium carbonate is a naturally occurring substance found in chalk, limestone and sea shells.
This is an FDA requirement for Natural Rubber Latex (NRL) glove products which must state that “This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.”
The FDA currently requires testing to publish the claim that any glove is appropriate for use with chemotherapy drugs. These are thicker (greater than 0.10 mm) latex and nitrile examination gloves. The OmniTrust™ #212 Powder Free Nitrile CF Gloves are certified safe for use with chemotherapy drugs.
Instead of powdering gloves, some manufacturers dip gloves into a chlorinated solution. This process reacts with the natural rubber latex to reduce tackiness, thus eliminating the need for additional dusting powder. Extra washing during the chlorination process provides an added benefit by greatly reducing the level of soluble latex proteins. It also affects some cosmetic and physical glove characteristics (softness and color).
Chloroprene gloves are made of a synthetic material, yet possess the stretch, fit and feel of natural latex. They are made of resilient chloroprene (a colorless liquid organic compound which is used in the synthesis of neoprene and certain other rubbers) allowing for the increased dexterity and sensitivity necessary for delicate procedures. They are more puncture resistant than vinyl or latex, yet more comfortable than regular nitrile or vinyl gloves.
Class I Medical Device
A device for which the controls authorized by or under sections of the Federal Food, Drug and Cosmetic act are sufficient to provide reasonable assurance of the safety and effectiveness of the device.
Class II Medical Device
A device that cannot be classified as Class I device because the sections of the Federal Food, Drug and Cosmetic Act by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device for which there is sufficient information to establish special controls to provide such assurance, including the dissemination of guidelines. Medical Examination Gloves are considered Class II Devices.
A contained room in which contaminants such as dust are reduced to a very low level by special processes so that operations such as the manufacture and assembly of delicate equipment or working with biological materials, can be performed effectively. Clean room gloves are widely found in the electronic and pharmaceutical laboratory industries. There are several clean room class types, the lower the class number the cleaner the environment/less particulate allowed: Class 1 (M1.5), Class 10 (M2.5), Class 100 (M3.5), Class 1000 (M4.5) and Class 10000 (M5.5).
During the glove manufacturing process, chemicals are added, including accelerators (to help control the later vulcanization process) and antioxidants (to prevent deterioration of the rubber molecules in the final product by heat, moisture and ozone).
Contact urticaria or hives can appear within minutes or up to an hour or more after a sensitized individual comes in contact with allergens to which they are allergic. It is a Type I hypersensitivity reaction.
Controlled Environment Gloves
Controlled environment glove, also known as Clean Room Gloves, materials must provide protection against particulate contamination. They are widely used in electronics and pharmaceutical industries. Critical environment gloves are typically Class M 3.5 (Class 100) and M 5.5 (Class 10,000) and higher. Controlled environment gloves are made from polyester, nitrile and nitrile/rubber combinations, natural rubber latex, polyvinyl chloride (PVC) and polyurethane.
A compound made by polymerizing (joining) two or more dissimilar monomers.
A medical grade donning agent made from corn, under United States Pharmacopia (USP) requirements which is used as a donning agent for medical grade gloves.
The cross wise connecting part that connects parallel chains in a complex chemical molecule (as a polymer).
The upper portion of a glove which encircles the wrist. Designs range from straight, rolled (beaded) or fluted. Gauntlet cuffs offer the benefits of a safety cuff, plus a flared design that fits over the garment sleeve of the wearer.
Damaging effects that liquid chemicals, extreme heat, ozone, fatigue or other substances have on the physical properties of the gloves. Signs of degradation may include softening and tackiness, brittleness, loss of elasticity, growth or ballooning at the finger tips.
DEHP (di-2-ethylhexyl phthalate)
Sometimes known as DOP (di-octyl phthalate) is a commonly used plasticizer from the phthalate ester family and has been in use in flexible PVC (Poly Vinyl Chloride) products since the 1930’s in medical and packaging applications. Phthalates have been continuously monitored to ensure that their use is safe as small amounts of plasticizers can leach out of products under certain circumstances. Through the years there has been debates by the scientific community as to the safety of these plasticizers. OmniShield™ NSF Certified Vinyl Food Service Gloves are manufactured without DINP/DEHP/DOP.
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 for a long period of time (becomes chronic), symptoms may expand to include drying, scaling, peeling and keratosis (thickening and hardening of the skin).
This is the process of submerging glove formers (molds) into tanks containing a compound or a solution. The hand shaped formers are coated with a coagulant (e.g. calcium nitrate) and dipped into the latex to coat them with a thin film of latex. The coagulant converts the liquid latex into a wet gel on the former. Subsequent passage through a warm oven completes the coagulation process.
Donning Powder Caution Statement
As glove powder represents a potential hazard to the user and patient, particularly in association with NRL proteins. The FDA recommends the following statement appear on glove packaging: “Caution: Users should consider the circumstances of use in deciding whether to remove residual powder on glove after donning. Powder can be removed by wiping gloves thoroughly with a wet sponge, sterile wet towel or other effective methods.”
Putting one glove on your hand and then another glove over the first.
Sometimes known as a Modified Draize Test. This is a 200 person challenge test which is 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.
Dry Gel Leaching
Occurs after gloves pass through ovens, transforming them from a gel into a basic solid form. When the gloves are dry gel leached, their proteins may be reduced significantly.