📊 Evidence-Based Reference
Powder-Free Latex Examination Glove Surface Treated with Aloe Vera Gel
Perusahaan Getah Asas Sdn. Bhd.
Summary: The powder-free latex examination glove, surface treated with aloe vera gel, is primarily used in clinical settings to prevent contamination. Key evidence highlights its effectiveness in maintaining barrier integrity during use.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K022601 ↗
Decision Date ?
August 26, 2002
Product Code ?
LYY
Device Class ?
Class 1
Evidence ?
0 studies
The powder-free latex examination glove by Perusahaan Getah Asas Sdn. Bhd. was cleared through the FDA 510(k) pathway on August 26, 2002. It is classified as a Class 1 medical device.
What It Is
This device is a powder-free latex examination glove treated with aloe vera gel, designed to provide a protective barrier for clinicians during patient examinations. It is intended to reduce the risk of contamination and enhance user comfort.
FDA-Cleared Indications
- Used as an examination glove to provide a protective barrier between the wearer and the patient.
- Intended for use during medical examinations and procedures where barrier protection is needed.
Clinical Applications
- Routine patient examinations
- Medical procedures requiring disposable hand protection
- Dental examinations and procedures
- Protection against contamination and cross-contamination in clinical settings
Evidence Summary
The literature includes five studies, ranging from 1992 to 2014, examining various aspects of glove performance, including watertightness, skin health effects, and microbial penetration. Study types vary, including RCTs and observational studies.
Reported Outcomes
Published studies report that powder-free latex gloves maintain their integrity during clinical use, effectively preventing microbial penetration. They also reduce airborne powder levels compared to powdered gloves, minimizing allergen exposure.
Safety Profile
Reported complications include potential skin irritation from prolonged use, as noted in studies examining hand skin health. No significant adverse events related to glove integrity were reported.
Evidence Limitations
Evidence gaps include a lack of large-scale, long-term studies on the effects of prolonged glove use. Further research is needed to explore the impact of aloe vera treatment on skin health and glove performance.
Practical Considerations
- Contains natural rubber latex and should not be used by people with a known latex allergy; latex-safe alternatives may be appropriate.
- Select the correct glove size to reduce tearing, hand fatigue, and loss of dexterity.
- Inspect the package and glove for damage before use; use a new pair for each patient and dispose of gloves according to facility policy.
- The aloe vera surface treatment does not eliminate the need for hand hygiene before and after glove use.
- This is a wearable barrier, not an implantable device; MRI compatibility labeling is generally not applicable, although metal accessories or other equipment used with the gloves should be evaluated separately.
Frequently Asked Questions
What are the clinical indications for powder-free latex examination gloves?
These gloves are indicated for use in medical and dental procedures to prevent contamination and protect both patients and healthcare workers.
What outcomes have been reported in clinical studies?
Studies report effective barrier integrity and reduced airborne powder levels, with no significant microbial penetration during use.
What complications have been reported?
Reported complications include potential skin irritation from prolonged glove use, particularly in dental healthcare workers.
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.