Skin Sensitization Test (Modified Draize-95 Test) — Draize-95  

Skin Sensitisation Clinical Trial

Official title: Skin Sensitization 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 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.

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 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. ;

Related Conditions & MeSH terms

• Skin Sensitisation

• NCT number: NCT04274647
• Study type: Interventional
• Source: YTY Industry (Manjung) Sdn Bhd
• Status: Completed
• Phase: N/A
• Start date: September 10, 2019
• Completion date: February 12, 2020