Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim for a Powder Free Polychloroprene Surgical Gloves, Sterile. To evaluate whether residual chemical additives at a level on the gloves that may induce type IV allergy to the unsensitized general user population when using polychloroprene based surgical gloves

1. 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)
2. 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,

104 female (50%) and 104 male (50%)