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maxxus powder free orthopaedic latex surgical gloves
Johnson & Johnson Medical
Summary: Maxxus powder free orthopaedic latex surgical gloves are designed for surgical procedures requiring high tactile sensitivity. Key evidence highlights their use in reducing glove perforation risks during surgery.
FDA Clearance Information
Pathway
510K
Number
K962986 ↗
Decision Date
September 20, 1996
Product Code
KGO
Device Class
Class 1
Evidence
0 studies
The maxxus powder free orthopaedic latex surgical gloves were cleared by the FDA through the 510(k) pathway on September 20, 1996. Manufactured by Johnson & Johnson Medical, they are classified as Class 1 devices.
What It Is
These are powder-free latex surgical gloves intended for use in orthopedic procedures. They provide a barrier to prevent contamination and are designed to offer enhanced tactile sensitivity for precise surgical tasks.
Clinical Applications
Commonly used in orthopedic surgeries, these gloves are suitable for procedures requiring high dexterity and sensitivity, such as arthroscopic surgeries and other delicate surgical interventions.
Evidence Summary
The available literature includes five studies, ranging from 1995 to 2024, encompassing randomized controlled trials and other study designs. These studies explore glove performance, safety, and factors influencing glove selection.
Reported Outcomes
Published studies report that the use of powder-free latex gloves can reduce the risk of glove perforation during surgical procedures. They also highlight improved handling of surgical materials compared to powdered gloves.
Safety Profile
Reported complications include glove perforations during arthroscopic surgeries, which can lead to increased risk of contamination. However, the use of powder-free gloves may mitigate some of these risks.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials specifically focused on these gloves. Further research is needed to evaluate long-term outcomes and safety in diverse surgical settings.
Frequently Asked Questions
What are the clinical indications for maxxus powder free orthopaedic latex surgical gloves?
These gloves are indicated for use in orthopedic and other surgical procedures where high tactile sensitivity and reduced risk of contamination are required.
What outcomes have been reported in clinical studies?
Studies report reduced glove perforation rates and improved handling of surgical materials with powder-free gloves compared to powdered alternatives.
What complications have been reported?
Safety data indicate that glove perforations can occur, particularly during arthroscopic procedures, but powder-free gloves may reduce this risk.
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.