đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as sterile surgical gloves during orthopedic surgical procedures.
- Provide a barrier between the hands of surgical personnel and the patient or surgical field.
- Support aseptic technique during procedures involving the musculoskeletal system.
Clinical Applications
- Joint replacement surgery
- Fracture repair
- Bone and joint surgery
- Other orthopedic procedures requiring sterile surgical gloves
Practical Considerations
- Latex gloves should not be used by staff or patients with a known latex allergy or latex sensitivity; a non-latex alternative may be appropriate.
- Select the correct glove size to support fit, comfort, tactile feedback and dexterity.
- Inspect packaging and gloves for damage before use, and follow the facility's sterile-glove and replacement procedures.
- These gloves are personal protective equipment and are not implants or therapeutic devices.
- MRI compatibility is generally not a relevant device characteristic for disposable surgical gloves; follow institutional MRI safety procedures and check packaging or labeling when needed.
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.