Post Market Clinical Follow Up Study of Examination Gloves

Post Market Clinical Follow Up study for Latex Examination Nitrile Gloves

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/06/043340

Enrollment

360

Registered

2022-06-20

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

None listed

Interventions

Intervention1: Latex Examination Gloves Powder Free Nitrile Examination Gloves Powder Free: Gloves are indicated for ?Protection of the wearer from contamination with blood, Secretions and excretions

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 subject -Subjects in which Examination Gloves is used during examination, diagnostic and therapeutic 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

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 Examination 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: 2-3 months	—

Measure

Time frame

The primary objective of this study is to confirm clinical performance and safety throughout the expected lifetime of the Examination 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: 2-3 months

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Secondary

Measure	Time frame
The Secondary Endpoint 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: 2-3 months	—

Measure

Time frame

The Secondary Endpoint 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: 2-3 months

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Countries

India

Contacts

Public ContactDR RADHIKA RANI AKKINENI

Dr.Radhikas Fertility and Surgical Center,Hyderabad,Telangana

draradhikarani@gmail.com9492810926

Outcome results