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resist tm orthopaedic surgical glove
Depuy
Summary: The Resist TM Orthopaedic Surgical Glove is a surgical glove designed for orthopedic procedures, cleared by the FDA via the 510k pathway. Key evidence highlights its role in reducing contamination and exposure risks during surgery.
FDA Clearance Information
Pathway
510K
Number
K913893 ↗
Decision Date
October 23, 1992
Product Code
KGO
Device Class
Class 1
Evidence
0 studies
The Resist TM Orthopaedic Surgical Glove was cleared by the FDA through the 510k pathway on October 23, 1992. It is manufactured by Depuy and classified as a Class 1 device.
What It Is
The Resist TM Orthopaedic Surgical Glove is designed to provide barrier protection for clinicians during orthopedic surgeries. Its primary function is to reduce the risk of contamination and exposure to bloodborne pathogens.
Clinical Applications
Commonly used in orthopedic surgeries such as total hip arthroplasty, the glove is intended to minimize the risk of surgical site contamination and protect healthcare workers from blood exposure.
Evidence Summary
The available literature includes four studies, ranging from 1992 to 2020. These studies encompass various designs, including retrospective and prospective analyses, focusing on glove efficacy and safety in surgical settings.
Reported Outcomes
Published studies report that the use of double gloving, including the Resist TM Orthopaedic Surgical Glove, significantly reduces bacterial contamination during procedures like total hip arthroplasty. Additionally, it helps in minimizing blood exposure risks for operating room personnel.
Safety Profile
Reported complications include the risk of glove perforation, which can compromise barrier protection. However, the use of double gloving has been shown to mitigate this risk, enhancing overall safety during surgical procedures.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to quantify the long-term efficacy and safety of these gloves in diverse surgical settings.
Frequently Asked Questions
What are the clinical indications for Resist TM Orthopaedic Surgical Glove?
The glove is indicated for use in orthopedic surgeries to reduce contamination and protect against bloodborne pathogens.
What outcomes have been reported in clinical studies?
Studies report reduced bacterial contamination and minimized blood exposure risks with the use of double gloving.
What complications have been reported?
Safety data indicate a risk of glove perforation, but double gloving reduces this risk, enhancing protection.
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.