Skin Sensitisation (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 Polychloroprene Rubber Containing Medical Device, Powder Free Polychloroprene Surgical Gloves, Sterile. (CR-SG-140-AF-WH)
• 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 Manual. Supporting Test Data: A negative skin sensitization test (Modified Draize-95 Test) on a minimum of 200 non-sensitized human subjects.

Inclusion criteria

• The test subjects are normal volunteers who have documented informed consent and have not participated in other voluntary testing for at least 30 days.
• Age of the test subjects ranged from 18 to 65 years.
• Efforts are made to provide racial and gender diversity of the test subjects that reasonably reflects the general user population in the US

Exclusion criteria

• The test subjects with any visible skin disease that might be confused with skin reactions caused by the test material.
• The test subjects with any indication of existing Type I allergy to natural rubber proteins.
• The test subjects who have used corticosteroids, either systemically or topically on the potential test site, two weeks before testing.
• Test subjects who have received endogenous or exogenous immunosuppressive treatments (or prolonged sun exposure).
• All subjects who are pregnant or become pregnant during the study.
• All lactating women,