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intercept free nitrile two toned white green textured fingertips powder-free non-sterile ambidextrous beaded cuff medical examination gloves tested for use with opioids fentanyl citrate heroin and both opioids in simulated gastric acid vomit
Summit Glove
Summary: Intercept Free Nitrile Gloves are medical examination gloves designed for safe handling of opioids like fentanyl and heroin. They are used by healthcare professionals in various settings to prevent contamination and ensure safety.
FDA Clearance Information
Pathway
510K
Number
K220375 ↗
Decision Date
April 13, 2022
Product Code
LZA
Device Class
Class 1
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on April 13, 2022. Manufactured by Summit Glove, it is classified as a Class 1 medical device under product code LZA.
What It Is
The Intercept Free Nitrile Gloves are powder-free, non-sterile, ambidextrous gloves with textured fingertips and a beaded cuff. They are specifically tested for use with opioids, including fentanyl citrate and heroin, providing a barrier against these substances even in simulated gastric acid vomit. These gloves are essential in minimizing the risk of exposure to hazardous drugs for healthcare workers.
Clinical Applications
These gloves are commonly used in emergency departments, addiction treatment centers, and forensic labs where there is a risk of exposure to opioids. They are crucial for clinicians handling patients with opioid overdose or those involved in drug testing and analysis. The gloves are also used in scenarios requiring protection from contamination and infection control.
Indications for Use
The FDA indications highlight the gloves' suitability for handling opioids like fentanyl and heroin, making them ideal for healthcare settings where exposure to these substances is possible. They are designed to protect healthcare workers from accidental exposure.
Practical Considerations
The gloves are available in various sizes to ensure a proper fit for all users. Their textured fingertips enhance grip, which is beneficial when handling delicate instruments or performing procedures. They are compatible with a wide range of medical environments due to their durable and flexible material.
Frequently Asked Questions
What is Intercept Free Nitrile Gloves used for?
These gloves are used for handling opioids safely, protecting healthcare workers from exposure to substances like fentanyl and heroin.
What specialties typically use this device?
Specialties such as emergency medicine, addiction treatment, and forensic science frequently use these gloves.
What are the FDA-cleared indications?
The gloves are indicated for use with opioids, including fentanyl and heroin, to protect against exposure even in simulated gastric acid vomit.
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.