đź“Š Evidence-Based Reference
Maxxus Orthopaedic Surgical Gloves
Johnson & Johnson Medical
Summary: Maxxus orthopaedic surgical gloves are designed for use in orthopedic surgeries to maintain sterility. Key evidence highlights the importance of glove integrity and aseptic techniques.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K953641 ↗
Decision Date ?
September 15, 1995
Product Code ?
KGO
Device Class ?
Class 1
Evidence ?
0 studies
The maxxus orthopaedic surgical gloves were cleared by the FDA via the 510(k) pathway on September 15, 1995. Manufactured by Johnson & Johnson Medical, they are classified as Class 1 under product code KGO.
What It Is
Maxxus orthopaedic surgical gloves are medical gloves intended for use in orthopedic surgeries. They are designed to provide a sterile barrier to prevent contamination during surgical procedures.
FDA-Cleared Indications
- Use as a sterile barrier during orthopedic surgical procedures.
- Use by surgical personnel to help maintain aseptic conditions during procedures involving the musculoskeletal system.
Clinical Applications
- Orthopedic surgery involving bones and joints
- Trauma surgery involving the musculoskeletal system
- Joint replacement and reconstruction procedures
- Spine and other orthopedic procedures requiring a sterile surgical barrier
Evidence Summary
The literature includes 10 studies, ranging from 2022 to 2025, covering various aspects of glove use in surgery. Study types include RCTs, prospective, retrospective, and case series.
Reported Outcomes
Published studies report that maintaining glove integrity is crucial for preventing bacterial contamination during orthopedic surgeries. Techniques such as double gloving and periodic glove changes are recommended to enhance sterility.
Safety Profile
Reported complications include glove perforation and bacterial contamination, which can compromise the sterile field. Proper glove handling and aseptic techniques are critical to minimize these risks.
Evidence Limitations
Current evidence lacks comprehensive data on the long-term efficacy of different glove materials. Further research is needed to explore the impact of glove use on surgical outcomes and infection rates.
Practical Considerations
- Select the correct glove size and inspect the package and gloves for damage before use.
- Use sterile technique when opening, donning and changing the gloves; replace gloves if torn, punctured or contaminated.
- The gloves are intended to support aseptic technique but do not replace hand hygiene, surgical preparation or other infection-prevention measures.
- Latex content, powdering and material compatibility should be checked against the product labeling and the user's allergy history.
- These gloves are not implanted devices and have no MRI-specific implant safety concerns; remove or replace them according to operating-room protocol.
Frequently Asked Questions
What are the clinical indications for maxxus orthopaedic surgical gloves?
Maxxus orthopaedic surgical gloves are indicated for use in orthopedic surgeries to maintain a sterile environment and prevent contamination.
What outcomes have been reported in clinical studies?
Studies report that glove integrity is vital for preventing contamination, with recommendations for double gloving and periodic changes.
What complications have been reported?
Safety data indicate risks of glove perforation and bacterial contamination, emphasizing the need for proper aseptic techniques.
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.