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encore powder-free surgical gloves orthopaedia
Smith & Nephew Perry
Summary: Encore Powder-Free Surgical Gloves Orthopaedia are sterile, disposable gloves used in surgical settings to maintain hygiene and prevent contamination. They are primarily used by surgeons and operating room staff.
FDA Clearance Information
Pathway
510K
Number
K932664 ↗
Decision Date
December 22, 1993
Product Code
KGO
Device Class
Class 1
Evidence
0 studies
The Encore Powder-Free Surgical Gloves Orthopaedia by Smith & Nephew Perry were cleared through the FDA 510k pathway on December 22, 1993. They are classified as a Class 1 medical device.
What It Is
Encore Powder-Free Surgical Gloves Orthopaedia are designed to provide a sterile barrier during surgical procedures, reducing the risk of infection and cross-contamination. These gloves are powder-free, minimizing the risk of allergic reactions and powder-related complications. They are made from high-quality materials to ensure durability and tactile sensitivity, which is crucial for precise surgical tasks.
Clinical Applications
These gloves are commonly used in various surgical procedures across specialties such as orthopedics, general surgery, and urology. They are essential in operating rooms, outpatient surgical centers, and other sterile environments. The gloves are suitable for use with a wide range of patient populations, including those undergoing prostate artery embolization, where maintaining a sterile field is critical.
Indications for Use
The FDA indications for these gloves include their use in maintaining sterility during surgical procedures. They are intended for healthcare professionals performing surgeries or procedures that require a sterile environment.
Practical Considerations
Encore Powder-Free Surgical Gloves Orthopaedia are available in multiple sizes to ensure a proper fit for all users. They are compatible with various surgical instruments and techniques. Clinicians should select the appropriate size to maintain dexterity and comfort during procedures.
Frequently Asked Questions
What is Encore Powder-Free Surgical Gloves Orthopaedia used for?
These gloves are used to maintain sterility and prevent contamination during surgical procedures.
What specialties typically use this device?
Specialties such as orthopedics, general surgery, and urology commonly use these gloves.
What are the FDA-cleared indications?
The gloves are indicated for use in maintaining a sterile environment during surgical 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.