Skin Sensitization Test (Modified Draize-95 Test)

• To evaluate whether residual chemical additives at a level that may induce Type IV allergy in the unsensitized general user population are present in a finished rubber containing medical device.
• To meet requirements for claim: This product demonstrated reduced potential for sensitizing users to chemical additives as described in Guidance for Industry and FDA Staff - Medical Glove Guidance Manual9. Supporting Test Data: A negative skin sensitization test (Modified Draize-95 Test) on a minimum of 200 non-sensitized human subjects.

Inclusion criteria

• Subjects must be aged 18 and 65 years, inclusive;
• Subjects who have not participated in other voluntary testing for at least 30 days;
• Subjects must be capable of understanding and following directions.
• Female subjects must produce a negative urine pregnancy test prior to the initiation and also at the completion of the tiral.

Exclusion criteria

• Subjects who are in ill health;
• Subjects who are taking medication, other than birth control, which could influence the purpose, integrity or outcome of the tiral;
• Subjects who have used topical or systemic corticosteriods, anti-inflammatories, antihistamines or antibiotics within 2 weeks prior to trial initiationor during their participation on this tiral;
• Femable subjects who are pregnant as evidenced by a urine pregnancy test, planning to become pregnant or lactaticn during the tiral;
• Subjects who have a history of adverse reactions to cosmetics, OTC drugs, or other personal care products;
• Subjects who introduce the use of any new cosmetic, toiletry or personal care products during the trial;
• Subjects with any visible skin disease that might be confuesd with skin reactions caused by the test material;
• Subjects with any knowledge or indication of existing Type IV allergy (delayed hypersensitivity) to natural rubber chemical additives;
• Subjects with a history of frequent irritation; or
• Subjects who have received endogenious or exogenious immunosuppressive treatment (r prolonged exposure to sun).