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maxxus lp orthopaedic latex surgical gloves
Johnson & Johnson Medical
Summary: Maxxus LP Orthopaedic Latex Surgical Gloves are specialized gloves used during orthopedic surgical procedures to provide barrier protection. They are primarily used by surgeons and surgical teams.
FDA Clearance Information
Pathway
510K
Number
K945157 ↗
Decision Date
February 13, 1995
Product Code
KGO
Device Class
Class 1
Evidence
0 studies
The Maxxus LP Orthopaedic Latex Surgical Gloves were cleared through the FDA 510(k) pathway on February 13, 1995. Manufactured by Johnson & Johnson Medical, these gloves are classified as Class 1 under product code KGO.
What It Is
The Maxxus LP Orthopaedic Latex Surgical Gloves are designed to offer enhanced protection and dexterity for surgeons performing orthopedic procedures. Made from high-quality latex, these gloves provide a reliable barrier against contaminants while allowing for precise movements. They are typically used in sterile environments to maintain aseptic conditions during surgeries.
Clinical Applications
These gloves are commonly used in orthopedic surgeries, where maintaining a sterile field is crucial. They are suitable for procedures involving bone and joint surgeries, such as joint replacements or fracture repairs. Surgeons, surgical assistants, and scrub nurses in hospitals and surgical centers are the primary users, ensuring patient safety and infection control.
Indications for Use
The FDA indications suggest these gloves are intended for use in surgical settings requiring barrier protection, particularly in orthopedic procedures. They help prevent contamination and infection during surgeries involving the musculoskeletal system.
Practical Considerations
These gloves are available in various sizes to ensure a proper fit for different users, enhancing comfort and dexterity. Compatibility with standard surgical techniques is ensured, but users should verify latex allergies in patients and staff to prevent allergic reactions.
Frequently Asked Questions
What is Maxxus LP Orthopaedic Latex Surgical Gloves used for?
They are used to provide barrier protection during orthopedic surgical procedures.
What specialties typically use this device?
Orthopedic surgeons and surgical teams in hospitals and surgical centers use these gloves.
What are the FDA-cleared indications?
These gloves are indicated for use in surgical settings requiring barrier protection, especially in orthopedic procedures.
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.