General Glove Use Manufacturing and Testing Latex Allergy

Glove Powder and Protein Synthetic Gloves

General Glove Use

1) Can you use hand lotion under latex gloves?

It is recommended to use hand lotion in between or after glove use only. If you are to use hand cream or lotion under Adenna latex exam gloves, please choose one that is water-based and not petroleum or oil-based. Petroleum or oil-based lotions may deteriorate the barrier properties of the gloves.

2) Why do some gloves produce brown stains when you put them on?

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.

3) Do Adenna Latex Exam Gloves receive the ADA Seal of Approval?

Adenna LPX Latex Powdered Exam Glove has received the ADA Seal of Approval. However, the ADA requires a different limit of protein claim from the FDA for powder free latex exam gloves. The ADA's is 200 ug/gm of gloves instead of 50 ug/gm of glove.

Therefore, to apply for the ADA Seal of Approval for Adenna Platinum or Gold Latex Powder Free Exam Gloves, Adenna would have to change the protein claim labeling on the dispensing boxes from "less than 50 mg/gm of glove", to "less than 200 mg/gm of glove". It is Adenna's desire not to apply for the ADA Seal of Approval for the Latex Powder Free Exam Gloves at the present time.

4) Do Adenna gloves comply with the USDA requirements for safe use in food handling?

Yes, Adenna 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. Adenna exam gloves, which are made in compliance with the FDA and the Federal Food, Drug and Cosmetic Act (FFDCA), are therefore safe for preparing, washing and processing meat, poultry, seafood, vegetables, desserts, beverages, etc in all USDA inspected establishments.

5) How can you tell if a glove has degraded and should not be used?

A glove may have degraded when it turns hard or brittle and loses its elasticity, or turns too soft and does not return into shape after being stretched. Change of color in the glove should also be a warning sign. DO NOT use gloves that show signs of degradation. Always follow Adenna's guidelines in storing gloves to preserve their shelf life, and rotate stock by practicing FIFO, First-in First-out inventory control.

In addition, use gloves prior to their expiration date. The FDA has proposed to glove manufacturers to add expiration dates to their glove products. Adenna has spearheaded this effort by marking expiration dates on both dispensing boxes and outer cartons of all Adenna gloves.

6) What are the storage guidelines for Adenna gloves?

Always store Adenna gloves in the original packaging in a cool, dry and well ventilated area. Stay away from dust, sunlight, moisture, X-ray, and excessive heat above 100 F (37 C).

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Manufacturing and Testing

7) What is a chlorination process in manufacturing gloves?

Chlorination is a process where chlorine, ammonia, water and other chemicals are used in the manufacturing of gloves. Adenna Gold Latex Powder Free Exam Gloves are manufactured with a proprietary single chlorination process.

This chlorination process removes powder and breaks down latex protein as well as chemical residue on or near the glove surface. Then through multiple washing and leaching processes, the protein and chemicals are further reduced to produce Adenna Gold gloves that meet the FDA's lowest allowable protein claim of less than 50 mg/dm2 of glove.

8) How are Adenna chlorinated gloves different from others?

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.

Adenna developed a single chlorination process that avoids all the above problems and gives users Adenna Gold: a glove that is very light in color, odor free, strong and durable. The interior smooth surface makes donning the glove very easy, yet, the outer textured surface maintains a 'tacky' non-slip grip. Furthermore, these gloves are flat stacked in the dispensing box that makes dispensing very convenient.

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Latex Allergy

9) What are latex allergies?

Some individuals may experience discomfort in the hands or have allergic reactions when wearing or after wearing latex or plastic gloves. It has been known that products 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.

However, the exact cause of latex allergies is still unknown. Researchers are also unable to determine the exact level of latex protein, or the length of time an individual needs to be exposed to become allergic.

10) What are the different types of hypersensitivity?

The adverse reactions associated with natural rubber latex affecting some individuals can be classified into the following three types:

11) Are gloves that have "hypoallergenic" claim safe for everyone?

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 has been based on the results of the modified Draize test, which may be appropriate for detecting sensitization to residual levels of processing chemicals in a product. But the test does not detect 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 web site at: http://www.fda.gov

12) Who is at risk?

Latex allergies, which emerged as a medical concern in the early 90's, affects approximately 2 -3% of general population in the United States, including up to 10% of health care workers.

A select group of people are also at higher risk than others, such as healthcare workers, children and individuals with spina bifida, persons with multiple operations and certain industry workers, such as those in the rubber industry.

13) How can you prevent and protect yourself from latex allergy?

All patients should be questioned about a history of latex allergies when being admitted. A history suggestive of reactions to latex may include any symptoms suffered from contact with rubber products. Patients who have latex allergy or patients with spina bifida, regardless of their history, should be treated in a latex free environment.

Many medical facilities have chosen to use only low protein, powder free gloves to help prevent latex allergies. If you are at a high risk of developing latex allergies, non-latex synthetic gloves such as vinyl or nitrile gloves should be considered and glove usage should be minimized.

In addition, protect yourself by…

• Learning to recognize different symptoms of latex allergies;
• If you or a patient develops symptoms of latex allergy, avoid direct contact with latex products immediately, and see a physician who is experienced in treating latex allergy;
• If you have latex allergy, cease contact with all latex products and latex gloves, and warn your employers, coworkers, physicians, nurses, and dentists that you have latex allergy;
• Reduce your exposure to latex gloves and the powder from latex gloves worn by others. Monitor your symptoms closely and whenever possible, substitute any latex products you may come in contact with non-latex products.

For more information on latex allergy, please consult with your physician or an allergist.

14) What can you do to help relieve or treat Irritant Contact Dermatitis or Type IV - Chemical Hypersensitivity?

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;
• Change detergents or soaps used in washing hands;
• Wear larger size gloves to allow for air circulation;
• Switch to a different brand of gloves;
• Use anti-inflammatory or healing hand lotions or hand creams in between or after glove use.

15) How can you treat Type I - Latex Protein Hypersensitivity?

There are medications available to help alleviate some symptoms of latex allergy, but currently, there are no permanent treatments or cure.

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Glove Powder and Protein

16) Does glove powder cause latex allergy?

Glove powder, 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, and 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, such as Adenna LPX Latex Powdered Exam Gloves; or low protein and powder free gloves such as Adenna Platinum and Gold Latex Powder Free Exam 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 choose only low protein powder free gloves should be used.

17) What kind of powder does Adenna use on the gloves?

Adenna uses only USP (United States Pharmacopeia) absorbable dusting powder, or modified cornstarch on the powdered gloves as a donning agent. We also use calcium carbonate as a mold-releasing agent to aid in removing gloves from the formers (hand molds).

18) How much powder can be found on an Adenna glove?

Currently, neither the ASTM nor the FDA has established the maximum powder level on powdered gloves. Different powdered gloves on the market today may carry powder levels from the low of 80 mg of powder per glove to the high of 800 mg of powder per glove.

The ASTM and the FDA are considering establishing the maximum powder level on powdered gloves at 120 mg of powder per glove. Adenna has already been manufacturing all the powdered exam gloves with less than 120 mg of powder per glove.

19) Are powder free gloves completely powder free?

Due to the different manufacturing processes for 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.

Currently, Adenna manufactures all powder free exam gloves at a maximum powder limit of 2 mg per glove.

20) Is there a limit on protein levels on latex exam gloves?

The FDA and ASTM are considering an upper limit on water-soluble protein for latex exam gloves. The upper limit being considered now is 200 ug/gm of glove. Adenna LPX Latex Powdered Exam Gloves have been consistently tested with latex protein of less than 200 ug/gm of glove. (Test reports on file)

The FDA and ASTM have established the lowest allowable water-soluble protein claim for any exam gloves to be 50 ug/gm of glove. Both Adenna Platinum and Gold Powder Free Latex Exam Gloves have received FDA 510(k) letters to be lawfully marketed with such a protein claim. This protein claim can be found on the side panel of glove dispensing box. (See Testing Reports)

21) Is a protein claim mandatory?

No, currently a protein claim or protein labeling is not mandatory.

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Synthetic Gloves

22) How are synthetic vinyl gloves compared to latex gloves?

Vinyl (PVC) is one of the synthetic materials used in the manufacturing of exam gloves. However, research has shown that vinyl gloves are not 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 they are not as good as latex gloves in barrier protection.

Latex gloves, with their excellent durability, fit better and more comfortably on the hands and stretch 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 in contact with all latex products, and wear only non-latex synthetic gloves. There are also other alternatives of non-latex gloves besides vinyl gloves.

However, switching to vinyl gloves does not eliminate the risk of irritant contact dermatitis or chemical hypersensitivity (Type IV) reaction, because these are caused by the residual chemicals used in the manufacturing of both vinyl and latex gloves, rather than latex protein.

23) How are other synthetic gloves compared to latex gloves?

The fit and comfort level of a glove have a great impact on your ability to perform your tasks. Here, we compare the properties and characteristics of different synthetic glove materials to latex:

Material	Properties	Characteristics
Latex	Soft, elastic, stretchable, great elongation	Fit well and comfortable
Vinyl	High modulus, low elongation	Limited flexibility and dexterity
Polyurethane	High tensile strength, medium modulus, low elongation	Stretchable, soft, fit and feel well
Nitrile, Neoprene	High modulus, reduced elasticity, low elongation	Vary, limited fit, feel and flexibility
Styrene Co-polymer such as Tactylite, Allergard	High modulus, high tensile strength, high permanent set	Limited flexibility and dexterity