NCT04274647

Skin Sensitization Test (Modified Draize-95 Test)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: YTY Industry (Manjung) Sdn Bhd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Skin Sensitisation

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2019-09-10
• Primary completion: 2020-02-04
• Completion: 2020-02-12
• First posted: 2020-02-18
• Last updated: 2020-02-18

Locations

1 site across 1 country: Malaysia