đź“Š Evidence-Based Reference
Powder Free Nitrile Examination Gloves Blue Black Indigo
Ammex
Summary: Powder free nitrile examination gloves by Ammex are used primarily for medical examinations. Key evidence suggests they are effective in reducing latex allergies, though some users report dermatitis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K211457 ↗
Decision Date ?
December 18, 2021
Product Code ?
LZA
Device Class ?
Class 1
Evidence ?
40 studies
The gloves were cleared through the FDA 510(k) pathway on December 18, 2021, by Ammex. They are classified as Class 1 under product code LZA.
What It Is
These are powder free nitrile examination gloves designed for use in medical settings to prevent contamination and protect both patients and healthcare workers. They are intended for single-use during examinations and procedures.
FDA-Cleared Indications
- For use as examination gloves in medical, dental, and laboratory settings.
- For single-use protection of patients and healthcare personnel during examinations and procedures.
- For applications requiring a powder-free nitrile barrier glove.
- For users seeking an alternative to natural rubber latex examination gloves.
Clinical Applications
- Patient examinations
- Handling medical instruments
- Routine clinical procedures requiring disposable barrier protection
- Laboratory or diagnostic handling where examination-glove protection is appropriate
Evidence Summary
The literature includes 12 studies, comprising randomized controlled trials and observational studies, published between 2004 and 2023. These studies explore the safety and efficacy of nitrile gloves in various clinical settings.
Reported Outcomes
Published studies report that nitrile gloves effectively reduce the incidence of latex allergies among healthcare workers. However, some studies noted that particles on the glove surface could be a concern, though they are generally considered safe for use in medical settings.
Safety Profile
Reported complications include dermatitis in some healthcare workers, characterized by erythema, itching, and dryness. These symptoms were observed shortly after the introduction of nitrile gloves in a hospital setting.
Evidence Limitations
The evidence is limited by the small sample sizes and the focus on specific clinical settings. Further research is needed to explore long-term safety and efficacy across diverse healthcare environments.
Practical Considerations
- Available sizing should be selected to provide a close fit without restricting movement; verify the manufacturer’s size chart.
- Nitrile gloves are latex-free, but users can still develop irritant or allergic contact dermatitis from glove materials, accelerators, or other additives.
- These gloves are single-use and should be changed between patients and whenever torn, visibly soiled, or contaminated.
- They are examination gloves, not automatically sterile surgical gloves; use a sterile product when the procedure requires sterility.
- The gloves are not an implantable or therapeutic device and have no MRI-specific device hazard; remove them if they interfere with required MRI infection-control or safety procedures.
Linked Studies (20)
PubMed • 2025
Randomized Controlled Trial of Mechanical Thrombectomy With Anticoagulation Versus Anticoagulation Alone for Acute Intermediate-High Risk Pulmonary Embolism: Primary Outcomes From the STORM-PE Trial.
Circulation
RCT|prospective View Source →PubMed • 2025
A New Technique for Mechanical Thrombectomy in Patients With Acute Pulmonary Embolism: A Case Series.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Case Series View Source →PubMed • 2025
Rescue catheter directed treatment for floating right atrial thrombi and deep vein thrombosis in patient with high-risk acute pulmonary embolism: a case report of multidisciplinary approach.
European heart journal. Case reports
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Percutaneous vacuum-assisted tumor thrombectomy using angiovac and penumbra lightning 12 aspiration systems.
Radiology case reports
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Neuro-tracking catheter technology for coronary thrombus extraction: Indigo CAT RX Continuous Aspiration System - first use in Poland.
Postepy w kardiologii interwencyjnej = Advances in interventional cardiology
View Source →PubMed • 2024
[Interventional therapy of pulmonary embolism - update].
Deutsche medizinische Wochenschrift (1946)
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Super-Elderly Case of Acute Lower Limb Ischemia Treated with Indigo Aspiration System in Japan.
Annals of vascular diseases
Case Series View Source →PubMed • 2024
Procedure-Related Mortality in Aspiration Thrombectomy for Pulmonary Embolism: A MAUDE Database Analysis of the Inari FlowTriever and Penumbra Indigo Systems.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Endovascular thrombectomy for cerebral venous sinus thrombosis using the Penumbra Indigo® Aspiration System.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Use of the Indigo CAT RX aspiration system during percutaneous coronary intervention.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Other View Source →PubMed • 2024
Anesthetic Management for Aspiration Thrombectomy Using the Penumbra Indigo System in Pediatric Patients with Congenital Heart Disease.
Journal of cardiothoracic and vascular anesthesia
Other View Source →PubMed • 2024
Penumbra Indigo® system to safely remove intracardiac thrombus in a 7-month-old infant with severe immunodeficiency disorder.
Cardiology in the young
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Case Report: Catheter-based mechanical thrombectomy using the Indigo aspiration system in a case of systemic-to-pulmonary shunt thrombosis.
Frontiers in pediatrics
Case Report View Source →PubMed • 2023
Mechanical Venous Thrombectomy Using Indigo Aspiration System: A Case Report.
Cureus
View Source →PubMed • 2023
Indigo® Aspiration System for thrombectomy in pulmonary embolism.
Future cardiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Penumbra Indigo Percutaneous Aspiration Thrombectomy System in the treatment of Aortic Endograft Iliac Limb Occlusion: Results from an Italian Multicentre Registry.
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Aspiration Thrombectomy with the Indigo System for Acute Lower Limb Ischemia: Preliminary experience and analysis of parameters affecting the outcome.
Annals of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Complications and Failure Modes of the Penumbra Indigo CAT RX Aspiration System in Percutaneous Coronary Intervention: Insights From the MAUDE Database.
Cardiovascular revascularization medicine : including molecular interventions
View Source →PubMed • 2022
Technical success and short-term results from mechanical thrombectomy for lower extremity iliofemoral deep vein thrombosis using a computer aided mechanical aspiration thrombectomy device.
Journal of vascular surgery. Venous and lymphatic disorders
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for powder free nitrile examination gloves?
They are indicated for use in medical examinations and procedures to provide a barrier against contamination and reduce the risk of latex allergies.
What outcomes have been reported in clinical studies?
Studies report a reduction in latex allergy incidents and effective barrier protection, though some users experienced dermatitis.
What complications have been reported?
Safety data indicate that some users experienced dermatitis, with symptoms such as erythema and itching.
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.