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Clinical Investigation of Sterile Latex Examination Gloves -Powdered and Powder Free (Powdered & Powder free)

Study to evaluate safety and performance of Sterile Latex Examination Gloves- Powdered and Powder Free

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/040979
Enrollment
400
Registered
2022-03-10
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K08- Other disorders of teeth and supporting structures

Interventions

Intervention1: Sterile Latex Examination Gloves - Powdered and Powder Free (Polymer Coated): Gloves are indicated for Primary prevention Protect patient and user from cross-contamination Conducting me

Sponsors

St Marys Rubbers Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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. Timepoint: 6 months to 1 year

Secondary

MeasureTime frame
The Secondary Endpoint is to demonstrate the performance of Sterile Latex Examination Gloves - Powdered and Powder Free (Polymer Coated). Timepoint: 6 months to 1 year

Countries

India

Contacts

Public ContactDr Parthasarathi Gayatri

Sagar Hospitals

gayat100@gmail.com9343012974

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026