đź“‹ FDA Reference
sensicare synthetic surgical glove liner
Bd Becton Dickinson Vacutainer Systems Preanalytic
Summary: The Sensicare Synthetic Surgical Glove Liner is a medical device used as a protective barrier during surgical procedures. It is primarily utilized by surgeons and operating room staff to enhance safety and hygiene.
FDA Clearance Information
Pathway
510K
Number
K950995 ↗
Decision Date
June 28, 1995
Product Code
LYN
Device Class
Class 2
Evidence
0 studies
The Sensicare Synthetic Surgical Glove Liner was cleared through the FDA 510k pathway on June 28, 1995. It is manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic and classified as a Class 2 device.
What It Is
The Sensicare Synthetic Surgical Glove Liner is a synthetic glove designed to be worn under surgical gloves. It provides an additional layer of protection against contamination and infection during surgical procedures. The glove liner is made from synthetic materials that are hypoallergenic, reducing the risk of allergic reactions compared to latex-based products.
Clinical Applications
This glove liner is commonly used in surgical settings, particularly in operating rooms where maintaining a sterile environment is crucial. It is used by surgeons, surgical assistants, and other healthcare professionals involved in invasive procedures. The glove liner is suitable for a wide range of surgical specialties, including general surgery, orthopedics, and cardiovascular surgery.
Indications for Use
The glove liner is indicated for use in surgical procedures where an additional barrier is needed to protect both the patient and healthcare provider from potential contamination. It is suitable for patients and staff with latex allergies or sensitivities.
Practical Considerations
The Sensicare Synthetic Surgical Glove Liner is available in various sizes to ensure a proper fit for different hand sizes. It is designed to be worn comfortably under standard surgical gloves without compromising dexterity or tactile sensitivity. Compatibility with different glove types should be verified before use.
Frequently Asked Questions
What is Sensicare Synthetic Surgical Glove Liner used for?
It is used as an additional protective barrier during surgical procedures to prevent contamination and infection.
What specialties typically use this device?
Surgical specialties such as general surgery, orthopedics, and cardiovascular surgery commonly use this device.
What are the FDA-cleared indications?
The glove liner is indicated for use in surgical settings to provide an extra layer of protection, especially for individuals with latex allergies.
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.