(76 days)
Not Found
No
The summary describes a standard patient examination glove and does not mention any AI or ML capabilities.
No
The device, a patient examination glove, is intended to prevent contamination, not to treat or alleviate a disease or condition.
No
This device is a patient examination glove, which is used to prevent contamination, not to diagnose medical conditions. Its intended use and the description of its physical properties and biocompatibility tests confirm its function as a barrier device, not a diagnostic tool.
No
The device is a physical medical device (patient examination gloves) and does not involve any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details the physical characteristics of the glove (material, color, scent, protein level). This aligns with a physical barrier device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the body, outside of the body (in vitro), to provide diagnostic or other medical information. This glove's function is purely a physical barrier during examination.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Product codes
LYY
Device Description
NON-STERILE ORANGE COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS AND WITH A PROTEIN LABELING CLAIM (
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
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JUN 1 2 2003