(76 days)
Not Found
No
The summary describes standard patient examination gloves and includes performance data related to physical properties and biocompatibility, with no mention of AI or ML.
No
The device, a patient examination glove, is intended to prevent contamination and is not designed to treat or diagnose a medical condition.
No.
The device, a patient examination glove, is intended to prevent contamination between the patient and examiner, not to diagnose or detect any disease or condition. Its described functions and performance studies primarily relate to its physical properties and biocompatibility as a barrier.
No
The device description clearly states it is a physical product (gloves) and the performance studies focus on physical properties and biocompatibility, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "Worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed in vitro (outside the body) on a sample.
- Device Description: The description details physical characteristics of a glove (material, color, scent, protein level). It doesn't describe reagents, instruments, or procedures for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical elements associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of specific analytes (biomarkers, pathogens, etc.)
- Diagnostic claims (e.g., diagnosing a disease, monitoring a condition)
- Use of reagents or testing kits
The device described is a medical device, specifically a patient examination glove, which falls under a different regulatory category than IVDs.
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 (comma separated list FDA assigned to the subject device)
LYY
Device Description
NON-STERILE GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR APPLE/PEPPERMINT 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.
0
JUN 1 2 2003
Appendix I, Page 1 (added)