Clinical Investigation of Sterile Latex Examination Gloves -Powdered and Powder Free(Powdered & Powder free)
Phase 4
- Conditions
- Health Condition 1: K08- Other disorders of teeth and supporting structures
- Registration Number
- CTRI/2022/03/040979
- Lead Sponsor
- St Marys Rubbers Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Subjects to be included in the study must meet the following eligibility criteria:
-Informed consent from the subject
-Subjects who use Sterile Latex Examination Glove for medical examinations, diagnostic and therapeutic procedures
Exclusion Criteria
-Subjects without informed consent
-Subject who are sensitive to latex
-Subject who are sensitive to powder content in Sterile Latex Examination Gloves Powdered.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Primary Endpoint is to demonstrate clinical safety of the Sterile Latex Examination Gloves - Powdered and Powder Free (Polymer Coated) and to observe any undesirable events like inflammation/allergy under normal condition of use. <br/ ><br> <br/ ><br>Timepoint: 6 months to 1 year
- Secondary Outcome Measures
Name Time Method The Secondary Endpoint is to demonstrate the performance of Sterile Latex Examination Gloves - Powdered and Powder Free (Polymer Coated). <br/ ><br> <br/ ><br>Timepoint: 6 months to 1 year