NCT04402476

Skin Sensitisation (Modified Draize-95 Test)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: PT. Medisafe Technologies · 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 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

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 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.

Conditions

• Skin Sensitisation

Interventions

Type	Name	Description
DEVICE	Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs.	Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.

Timeline

• Start date: 2019-11-23
• Primary completion: 2020-02-20
• Completion: 2020-04-06
• First posted: 2020-05-26
• Last updated: 2020-06-17

Locations

1 site across 1 country: Malaysia