Skin Sensitization Test (Modified Draize-95 Test)

Study Overview
=================
Brief Summary
-----------------
Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim for a Blue Non Sterile Powder Free Nitrile Examination Gloves. 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.

Detailed Description
-----------------
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.

Official Title
-----------------
Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim

Conditions
-----------------
Skin Sensitisation

Intervention / Treatment
-----------------
* Device: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device and Control<br>NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact. Positive control: 0.4% sodium lauryl sulfate (SLS) Dose. 0.2ml | Device: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE<br>* Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritation scored by Erythemal Scoring Scale | 0 - No visible reaction | 8 weeks |