Skin Sensitisation (Modified Draize-95 Test) — MDT-95  

Skin Sensitisation Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Skin Sensitisation

• NCT number: NCT04402476
• Study type: Interventional
• Source: PT. Medisafe Technologies
• Status: Completed
• Phase: N/A
• Start date: November 23, 2019
• Completion date: April 6, 2020