FAQ

It is recommended to use hand lotion in between or after glove use only. Use a hand cream or lotion that is water-based and not petroleum- or oil-based. Petroleum- or oil-based lotions may deteriorate the barrier properties of the gloves.

This is usually caused by the chemical reaction between your skin and the gloves. Before putting on gloves, your hands might come in contact with copper, iron or metal material, such as coins, or you may have heavy acidic perspiration in your hands. This can usually cause brown stains when wearing gloves. These brown stains do not affect the barrier properties of gloves.

Omni gloves are safe to be used in all types of food preparation or handling procedures. The USDA does not establish any official regulatory requirement for approval of gloves, but follows the guidelines of the FDA’s specifications.

It has been known that products other than gloves which contain natural rubber latex – such as balloons, balls, toys that contain rubber material; rubber bands, hoses, boots and rubber parts of instruments; tires, erasers, mouse pads, helmets, condoms, etc. – may cause irritation or allergic reactions in some individuals.

Omni International has been asked about this many times in the past year. The reality of this question is that wherever person-to-person or provider-to-patient touch is concerned, an examination-grade glove – or “medical” glove – is to be used. These glove boxes would be marked as medical or examination. General or multi-purpose gloves are not marked with either of those two words.

The FDA writes:

“Medical gloves are examples of personal protective equipment that are used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations.  Medical gloves are one part of an infection-control strategy.”

There are several very strong differences between an “examination” glove and a “general purpose” glove. However, the most important difference is the AQL or Acceptable Quality Level.

AQL is a quality specification that the FDA and all glove manufacturers use to specify the pinhole rate in surgical and examination gloves. The FDA specifies an AQL of 1.5 for surgical gloves and 2.5 for examination gloves. An AQL of 2.5 means the defect level from a large sampling of gloves will not be more than 2.5%.

General purpose gloves do not have any FDA standards, and many start at 4.0 AQL. Many could have higher AQLs.

The responsible glove wearer should also check with their respective city, county, and state regulations. Some jurisdictions may levy a fine for not using medical or exam gloves where person-to-person contact is used consistently.

Thus, the protect norm we feel is that person-to-person touch should only be done with a medical or examination glove.

Omni International can assure you this chemical is not used in any gloves that we manufacture.

Chlorination is a process whereby chlorine, ammonia, water and other chemicals are utilized in the manufacturing of gloves. The chlorination process removes powder and breaks down the latex protein as well as the chemical residue on or near the glove surface. Then, through multiple washing and leaching processes, the protein and chemicals are further reduced.

A poor chlorination process (including over-chlorination) can result in gloves that are brittle and weak, tear easily, and have dark yellow or brown discoloring. Sometimes the gloves can be very sticky and make donning impossible or be very slippery without grip on the surface.

Poor chlorination also produces gloves that have a strong chlorine odor. For obvious reasons, chlorinated powder free latex examination gloves should not be recommended for dental use.

Coagulant-coated formers are dipped into previously compounded and mature latex. When they reach the specified thickness, the newly formed gloves are sent to pre-oven leaching, an extensive procedure that results in the removal of residual calcium nitrate and some natural rubber proteins.

Post-oven leaching is very effective in removing natural rubber latex proteins from the glove surface. Washing the gloves with continually replenished hot water after the gloves pass through the ovens eliminates a significant amount of remaining natural rubber proteins.

Some individuals may experience allergic reactions when wearing or after wearing latex or plastic gloves. It has been known that products, other than gloves, which contain natural rubber latex, such as: balloons, balls, toys that contain rubber material; rubber bands, hoses, boots and rubber parts of instruments; tires, erasers, mouse pads, helmets, condoms, etc. may cause irritation or allergic reactions in some individuals.

These reactions range from dry, itchy, crusty skin with cracks or sores, to a runny nose, wheezing, difficulty breathing, swelling in the face, cramps and shock. Rare cases can even be potentially life-threatening.

As of this time, researchers are still unable to determine the exact level of latex protein, or the length of time an individual needs to be exposed to become allergic.

ASTM has set, and the FDA has proposed, a maximum of 200µg/g (µg/dm 2) for any glove. FDA has allowed a level of 50 µg/g (µg/dm 2) as a lower limit on claims using the Lowry test. The new ASTM ELISA test is hoped to be able to allow claims of 1/5th of that or less. While there are probably meaningful differences between 200, 50 and 10, users should be wary of attempting to make judgments on small differences in values in between these broad ranges.

No. The FDA has ruled and required that the labeling of “hypoallergenic” be removed from all glove packaging effective on September 30, 1998. The FDA has received reports of allergic reactions to medical gloves labeled as “hypoallergenic.”

The use of the “hypoallergenic” label had been based on the results of the modified Draize test, which may have been appropriate for detecting sensitization to residual levels of processing chemicals in a product. However, the test does not detect an individual’s sensitivity to natural latex protein.

The FDA believes that “hypoallergenic” labeling on devices that contain natural rubber latex is misleading, as it incorrectly implies that such devices may be used safely by individuals who are sensitive to natural latex protein.

Therefore, the FDA has required that hypoallergenic claims be removed from the labeling of all medical devices that contain natural rubber. For more information, please visit the FDA website at: http://www.fda.gov

There are several things you can do to help relieve these glove-related irritations or reactions:

• Consult with your physician, an occupational health professional or a dermatologist.
• Use powder free gloves that are low in chemicals.
• Try wearing cotton or nylon glove liners.
• Change gloves frequently.
• Try different detergents or soaps used in washing hands.
• Wear larger size gloves to allow for air circulation.
• Try a different brand or a different type (latex/vinyl/nitrile) glove.
• Use anti-inflammatory or healing hand lotions or hand creams (water-based) in between or after glove use.

Glove powder, which is used in the manufacturing process as a mold releasing agent and a donning lubricant, is also believed to be one possible cause of sensitization. However, it is important to understand that glove powder or cornstarch powder itself is not known to be an allergen.

It is during the manufacturing process whereby the glove powder can absorb some soluble protein. Via aerosolization, these powder particles become airborne. Inhalation or direct contact with these powder particles is alleged to bring about allergic reactions.

Therefore, it is important to use only gloves with low protein and low powder content or low protein and powder free gloves.

It is equally important to note that not all powder free gloves will have a low protein level. There are powder free gloves that contain a high level of latex protein. Therefore, the association of glove powder and soluble protein must be clarified, and only low protein powder free gloves should be used.

Removing powder from gloves is done “post-process,” meaning that the removal of powder occurs after the glove has been fully manufactured. This procedure is called chlorination.  While powder removal is the main objective, chlorination simultaneously removes a significant amount of the residual protein from the glove.

This reduction in residual protein is the reason powder free gloves are less likely to induce protein allergy reactions. Thus, the powder is not the source of protein allergy reactions.

Other powder removal processes simply substitute powder with a different coating agent like polyurethane or acrylic during production. While this eliminates powder from the gloves, the protein level remains the same as that of a pre-powdered glove. This can be misleading to end users.

Due to the different manufacturing processes of powder free gloves, they are not 100% completely powder free. The definition of powder according to the ASTM is anything that does not pass through a 2.7-micrometer glass microfiber filter by using suction filtration.

These may include cornstarch, calcium carbonate aggregates, latex particles, synthetic debris, packaging fibers, non-soluble lubricants, dust, etc. However, ASTM has set a maximum limit for powder at 4 mg per glove for all powder free gloves and has intended to further reduce the limit to 3 mg in the future, and then to 2 mg per glove.

Unlike latex, nitrile material does not contain latex proteins. Therefore, anyone who is allergic to latex proteins will not have latex protein-induced allergies when using nitrile gloves. This is an alternative product to latex.

Some users of nitrile gloves have reported allergic reactions triggered by other antigens in the synthetic material but not by proteins.

Vinyl (PVC) is just one of the synthetic materials used in the manufacturing of exam gloves. However, research has shown that vinyl gloves are generally not thought of as strong as latex gloves and they can be punctured more easily. They fit loosely to the hands due to their limited ability to stretch, and in the past, were not as good as latex gloves in barrier protection.

Latex gloves, with their excellent durability, fit better and more comfortably on the hands and have better stretch characteristics with more elasticity. They are stronger and provide superior barrier protection. Overall, latex gloves outperform vinyl gloves in both function and protection.

However, individuals who are allergic to latex protein (Immediate Type I) should avoid contact with all latex products, and wear only non-latex, synthetic gloves. There are also other alternatives of non-latex gloves besides vinyl gloves such as nitrile and chloroprene.

Switching to vinyl gloves may not eliminate the risk of irritant contact dermatitis or chemical hypersensitivity (Type IV) reaction, because these can be caused by the residual chemicals used in the manufacturing of both vinyl, nitrile and latex gloves, rather than just the latex.

Glove choice should also be appropriate to the situation. One should consider wearing non-latex gloves (such as vinyl) when the superior barrier protection of latex is not needed. So, for example, a very short procedure with minimal prospect for blood or body fluid contact might be one for which a vinyl glove could be considered an acceptable choice.

Even with synthetic rubbers, there are still numerous chemicals involved in manufacture. Once more, there will be differences from one manufacturer to the next. It is still possible to have a serious Type IV allergic reaction (contact dermatitis) to a synthetic rubber. However, Type I natural latex allergy does not occur in response to synthetic rubber and these gloves are therefore required when treating a patient with known type I hypersensitivity, or for the healthcare worker who has either become type I sensitized or cannot find a suitable latex glove because of type IV allergy.