Post Market Clinical Follow Up Study of Examination Gloves

Phase 4

Registration Number: CTRI/2022/06/043340

Lead Sponsor: PRIMUS GLOVES PRIVATE LIMITED

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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