Post Market Clinical Follow Up study is to confirm clinical performance and safety throughout the expected lifetime of the Surgical Gloves.

Post Market Clinical Follow up Study of Surgical Gloves

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/05/042748

Enrollment

756

Registered

2022-05-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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: Latex Surgical Gloves Powdered Latex Surgical Gloves Powder Free Nitrile Surgical Gloves Powder Free: Surgical Gloves are Disposable medical Device Intended for medical purpose that i

Eligibility

Inclusion criteria

Inclusion criteria: At the time of screening and usage of the product all subjects must meet the following criteria for inclusion into the study and the subjects must be which is prescribed by a medical practitioner. The inclusion criteria for the subjects for this study are as follows: -Informed consent from the PI on behalf of all the subjects -Subjects in which Surgical Gloves is used during surgical procedures.

Exclusion criteria

Exclusion criteria: The below Subjects are excluded from the study: -Subjects without informed consent -Subject who are sensitive to natural latex rubber -Subject who are sensitive to synthetic latex(for nitrile gloves only) -Subject who are sensitive to powder content in Surgical Gloves Powdered.

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to confirm clinical performance and safety throughout the expected lifetime of the Surgical Gloves, the acceptability and to assess the Safety and Performance of our Medical devices with a post market clinical study. The primary objective is also measuring if the product had met its intended use as claimed by the Primus Gloves Private Limited.Timepoint: The duration of the study is 2 to 3 months.	—

Measure

Time frame

The primary objective of this study is to confirm clinical performance and safety throughout the expected lifetime of the Surgical Gloves, the acceptability and to assess the Safety and Performance of our Medical devices with a post market clinical study. The primary objective is also measuring if the product had met its intended use as claimed by the Primus Gloves Private Limited.Timepoint: The duration of the study is 2 to 3 months.

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Secondary

Measure	Time frame
The Secondary Objective is to determine any undesirable events under normal condition of use and assess whether the risks outweigh the intended benefits of the device. This study will identify and analyze new emergent risks, known and unknown residual risks and contraindications identified and be formulated to address if any specific questions relating to the clinical safety or clinical performance of the device. The study will focus on identifying possible systematic misuse or off-label use of the device.Timepoint: The duration of the study is 2 to 3 months	—

Measure

Time frame

The Secondary Objective is to determine any undesirable events under normal condition of use and assess whether the risks outweigh the intended benefits of the device. This study will identify and analyze new emergent risks, known and unknown residual risks and contraindications identified and be formulated to address if any specific questions relating to the clinical safety or clinical performance of the device. The study will focus on identifying possible systematic misuse or off-label use of the device.Timepoint: The duration of the study is 2 to 3 months

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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