đź“‹ FDA Reference
encore powder-free latex surgical gloves orthopaedic with protein content labeling claim 50 micrograms or less
Ansell Healthcare Products
Summary: Encore Powder-Free Latex Surgical Gloves Orthopaedic are latex gloves with low protein content, used primarily in surgical settings to minimize allergic reactions. They are utilized by surgeons and healthcare professionals during orthopedic procedures.
FDA Clearance Information
Pathway
510K
Number
K003771 ↗
Decision Date
January 16, 2001
Product Code
KGO
Device Class
Class 1
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on January 16, 2001. Manufactured by Ansell Healthcare Products, it is classified as a Class 1 device under product code KGO.
What It Is
These are powder-free latex surgical gloves designed for orthopedic procedures, featuring a protein content labeling claim of 50 micrograms or less to reduce the risk of latex allergies. The gloves provide tactile sensitivity and dexterity, crucial for complex surgical tasks. They are made to fit comfortably and securely, ensuring safety and precision during operations.
Clinical Applications
Encore Powder-Free Latex Surgical Gloves are commonly used in orthopedic surgeries, where precision and tactile feedback are critical. They are suitable for use in hospitals, surgical centers, and clinics, particularly in procedures involving bone and joint manipulation. Surgeons, nurses, and surgical technicians in the fields of orthopedics and general surgery are the primary users.
Indications for Use
These gloves are intended for use in surgical procedures to protect both the patient and the healthcare provider from cross-contamination. They are particularly beneficial for patients and staff sensitive to latex, as they contain a reduced protein content.
Practical Considerations
The gloves are available in various sizes to ensure a proper fit for different hand sizes, enhancing comfort and dexterity. They are compatible with standard surgical techniques and can be used in conjunction with other surgical equipment. Proper sizing and donning techniques are essential to maintain glove integrity and effectiveness.
Frequently Asked Questions
What is Encore Powder-Free Latex Surgical Gloves Orthopaedic used for?
They are used in surgical settings, particularly for orthopedic procedures, to provide protection and tactile sensitivity.
What specialties typically use this device?
Orthopedic surgeons, general surgeons, and surgical staff in hospitals and surgical centers commonly use these gloves.
What are the FDA-cleared indications?
They are indicated for use in surgical procedures to minimize the risk of latex allergies and provide protection against cross-contamination.
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.