Skin Sensitisation
Conditions
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
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 rubber containing medical device. 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 Manual9. Supporting Test Data: A negative skin sensitization test (Modified Draize-95 Test) on a minimum of 200 non-sensitized human subjects.
Interventions
DEVICENON-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.
Sponsors
YTY Industry (Manjung) Sdn Bhd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Irritation scored by Erythemal Scoring Scale | 8 weeks | 0 - No visible reaction |
Countries
Malaysia
Outcome results
None listed