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Clinical Investigation of Sterile Latex Surgical Gloves- Powdered & Powder free

Study to evaluate Safety and Performance of Sterile Latex Surgical Gloves

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/040889
Enrollment
965
Registered
2022-03-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Sterile Latex Surgical Gloves - Powdered and Powder Free Sterile Latex Gynaecological Gloves- Powdered and Powder Free : Primary prevention -To prevent contamination of the patient dur

Sponsors

St Marys Rubber 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 using Sterile Latex Surgical Gloves Powdered and Powder Free for surgical procedure -Subjects using Sterile Latex Gynaecological Gloves Powdered and Powder Free for Gynaecological procedure

Exclusion criteria

Exclusion criteria: -Subjects without informed consent -Subject who are sensitive to latex -Subject who are sensitive to powder content in Sterile Latex Surgical Gloves Powdered and Sterile Latex Gynaecological Gloves Powdered.

Design outcomes

Primary

MeasureTime frame
The Primary Endpoint is to demonstrate clinical safety of the Sterile Latex Surgical Gloves Powdered and Powder Free and Sterile Latex Gynaecological gloves powdered and powder free and to observe any undesirable events like infection 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 Surgical Gloves Powdered and powder free and Sterile Latex Gynaecological Gloves Powdered and powder Free.Timepoint: 6 months to 1 year

Countries

India

Contacts

Public ContactDr Murali Mohan S

Sagar Hospitals,Jayanagar,Bangalore

drmurali78@gmail.com9483861505

Outcome results

None listed

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