(44 days)
Not Found
No
The device description and performance data relate to the physical properties and barrier function of examination gloves, with no mention of AI or ML technologies.
No.
The device's intended use is to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one. It does not treat or diagnose any disease or condition.
No
A patient examination glove is intended to prevent contamination between patient and examiner, not to diagnose a medical condition.
No
The device description clearly states it is a physical product (gloves) and the performance studies focus on physical properties and watertightness, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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." This describes a barrier device used for infection control during physical examinations.
- Device Description: The description details the physical characteristics of a glove (material, powder content, protein content, etc.).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically reagents, instruments, or systems used in vitro (outside the body) for these purposes.
- Performance Studies: The performance studies focus on the physical properties and barrier integrity of the glove (watertightness, tensile strength, elongation, etc.), which are relevant to its function as a protective barrier, not as a diagnostic tool.
In summary, the device is a medical glove used for protection and infection control during patient examinations, which falls under a different regulatory classification than In Vitro Diagnostics.
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
Powder Free, Natural and/or Colored Latex Exam Gloves, with Protein labeling (
§ 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
510(k) SUMMARY
| Submitted For: | YTY INDUSTRY (MANJUNG) SDN BHD |
|---|---|
| Submitted By: | TUCKER & ASSOCIATES |
| Official Correspondent for YTY INDUSTRY | |
| (MANJUNG) SDN BHD | |
| JANNA P. TUCKER, President-CEO | |
| 198 Avenue de la D'emerald | |
| Sparks, NV 89434-9550 | |
| Phone: 775-342-2612 | |
| Fax: 775-342-2613 | |
| E-Mail: Tuckerjan@aol.com | |
| Date of Submission: | 21 October 2002 |
| Device Name: | Powder Free, Natural and/or Colored Latex Exam |
| Gloves, with Protein labeling ( |