Skin Sensitization Test (Modified Draize-95 Test) to Support a Low Dermatitis Potential Claim for a Blue Non Sterile Powder Free Nitrile Examination Gloves. This study is a RIPT (Repeat Insult Patch Test) to evaluate whether residual chemical additives at the level that may induce Type IV allergy in the nonsensitized general user population are present in a finished Blue Non Sterile Powder Free Nitrile Examination Glove.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
245
Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.
Consumer Product Testing Company, Inc.
Fairfield, New Jersey, United States
Irritation scored by Erythemal Scoring Scale
Basic Score and Description: 0 - No visible reaction. 0.5 - Doubtful or negligible erythema reaction. 1.0 - Mild or just perceptible macular erythema reaction in a speckled/follicular, patchy or confluent pattern (slight pinking). 2.0 - Moderate erythema reaction in a confluent pattern (definite redness). 3.0 - Strong or brisk erythema reaction that may spread beyond the test site. If a subject develops a positive reaction (a score value of 1.5) to the test material or shows signs of irritation after patch applications, further patching on those individuals are stopped. In order to qualify for the claim of a reduced sensitization potential, all 200 individuals completing the study should exhibit a score value of no more than 1.5 based on the scoring criteria.
Time frame: 8 weeks
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