Original Research Article
Year: 2023 | Month: June | Volume: 10 | Issue: 6 | Pages: 526-535
DOI: https://doi.org/10.52403/ijrr.20230665
Uncovering the Efficacy and Safety of Powder-Free Latex Examination Gloves and Powder-Free Nitrile Examination Gloves: A Post-Market Clinical Follow-up Study
Radhika Rani Akkineni1, Chigurupati Venkata Pavan Kumar2, Ramaswamy Anikode Subramanian3, Mathangi Krishna Kumar4, Linu Thommi5, Krishna R Nath6, Agna Jose7
1Obstetrician and Gynecologist, 2General Surgeon, Dr. Radhika's Fertility and Surgical Center, Hyderabad
3Professor of Pathology, PESIMSR, Kuppam, 4Assistant Professor, Anaesthesia, St John’s Medical College
Hospital, Bengaluru,
5Clinical lead, CRO, 6Senior Clinical Research Associate, CRO, 7Junior Clinical Research Associate, CRO, Dr.
Klinisch Research Private Limited, Bengaluru, India
Corresponding Author: Ramaswamy Anikode Subramanian
ABSTRACT
This study evaluated the safety and performance of latex examination gloves powder free and nitrile examination gloves powder free. A total of 361 subjects participated in the study, with 181 using latex examination gloves powder free and 180 using nitrile examination gloves powder free. The performance of latex examination gloves powder free was rated as "satisfactory" (3.8) and that of nitrile examination gloves powder free as "good" (4.1). Clinical safety parameter analysis of latex examination gloves powder free showed that 87% of the users reported that the gloves did not fit perfectly. This may be due to the wrong size selection of gloves by the users for the procedure. No safety-related issues were reported by any of the users. No new risks were identified from the study for the products, and there was no addition to the residual risks that had already been identified in the Risk Management Report. None of the users reported any infection under normal condition of use, and there were no serious adverse events or adverse events reported.
Keywords: latex examination gloves powder free, nitrile examination gloves powder free, safety, performance, clinical safety, risk management
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