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maxxus orthopaedic latex surgical gloves
Johnson & Johnson Medical
Summary: Maxxus orthopaedic latex surgical gloves are designed for use in orthopedic surgeries to prevent surgical site infections. Key evidence highlights the importance of glove integrity in maintaining sterility during procedures.
FDA Clearance Information
Pathway
510K
Number
K935227 ↗
Decision Date
March 7, 1994
Product Code
KGO
Device Class
Class 1
Evidence
0 studies
The maxxus orthopaedic latex surgical gloves were cleared by the FDA through the 510(k) pathway on March 7, 1994. Manufactured by Johnson & Johnson Medical, they are classified as a Class 1 medical device.
What It Is
Maxxus orthopaedic latex surgical gloves are sterile, disposable gloves used primarily in orthopedic surgeries. They serve as a barrier to prevent contamination and infection during surgical procedures.
Clinical Applications
These gloves are commonly used in orthopedic surgeries such as arthroplasty and arthroscopy to maintain a sterile environment and protect both patients and healthcare providers from infection.
Evidence Summary
The literature includes 10 studies, ranging from retrospective analyses to randomized controlled trials, published between 1999 and 2025. These studies focus on glove integrity, infection prevention, and safety.
Reported Outcomes
Published studies report that the use of latex surgical gloves significantly reduces the risk of surgical site infections. However, the integrity of the gloves is crucial, as defects like perforations can compromise their effectiveness.
Safety Profile
Reported complications include glove perforations and tears, which can lead to increased risk of infection. Studies emphasize the need for careful inspection and handling to maintain glove integrity.
Evidence Limitations
The current evidence is limited by the variability in study designs and the focus on specific surgical settings. Further research is needed to explore the long-term effectiveness of these gloves across diverse surgical disciplines.
Frequently Asked Questions
What are the clinical indications for maxxus orthopaedic latex surgical gloves?
The gloves are indicated for use in orthopedic surgeries to prevent surgical site infections and protect against blood-borne pathogens.
What outcomes have been reported in clinical studies?
Studies have shown that these gloves effectively reduce the risk of infections when their integrity is maintained.
What complications have been reported?
Safety data indicate that perforations and tears are potential complications, which can compromise the gloves' protective function.
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.