đź“Š Evidence-Based Reference
biogel orthopaedic surgical glove with non-pryogenic statement
Molnlycke Health Care Us
Summary: The Biogel Orthopaedic Surgical Glove is a non-pyrogenic glove designed for use in orthopaedic surgeries. Key evidence highlights its durability and safety in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K071465 ↗
Decision Date
September 11, 2007
Product Code
KGO
Device Class
Class 1
Evidence
0 studies
The Biogel Orthopaedic Surgical Glove was cleared by the FDA via the 510(k) pathway on September 11, 2007. It is manufactured by Molnlycke Health Care Us and classified as a Class 1 device.
What It Is
The Biogel Orthopaedic Surgical Glove is a sterile, non-pyrogenic glove intended for use in orthopaedic surgical procedures. It is designed to provide a barrier against contamination and enhance tactile sensitivity for clinicians.
Clinical Applications
Commonly used in orthopaedic surgeries, the Biogel glove is suitable for procedures requiring high durability and sensitivity, such as joint replacements and fracture repairs.
Evidence Summary
The literature includes 7 studies ranging from 2001 to 2024, encompassing randomized controlled trials and prospective studies. These studies focus on glove durability, perforation rates, and material performance.
Reported Outcomes
Published studies report that the Biogel Orthopaedic Surgical Glove demonstrates superior durability compared to other brands. It is noted for its low perforation rates, making it a reliable choice in surgical settings.
Safety Profile
Reported complications include occasional glove perforations, particularly when handling certain materials like polymethyl methacrylate. However, overall safety is considered high with minimal adverse events.
Evidence Limitations
The evidence is limited by the variability in study designs and the focus on specific surgical scenarios. Further research is needed to explore long-term outcomes and performance in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for Biogel Orthopaedic Surgical Glove?
The glove is indicated for use in orthopaedic surgeries, providing a protective barrier and enhancing tactile sensitivity.
What outcomes have been reported in clinical studies?
Studies report high durability and low perforation rates, indicating reliable performance in surgical settings.
What complications have been reported?
Safety data indicates occasional perforations, especially when handling certain materials, but overall adverse events are minimal.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.