VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR

• K Number: K041745
• Device Name: VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
• Manufacturer: ARISTA LATINDO INDUSTRIAL, LTD. P.T.
• Date Cleared: 2004-07-15 ( 17 days)
• Product Code: LYZ
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Vinyl Examination Gloves, Powder Free, Green Color

AI/ML Overview

This document, a 510(k) premarket notification approval letter, does not contain the detailed information necessary to fully answer all aspects of your request. The letter confirms that Vinyl Examination Gloves, Powder Free, Green Color, manufactured by Arista Latindo Industrial Limited PT, are substantially equivalent to legally marketed predicate devices. However, it does not include a study describing acceptance criteria and device performance in the way you've outlined for an AI/CAD product.

Here's a breakdown of what can and cannot be extracted from the provided text:

Information Available:

• Device Name: Vinyl Examination Gloves, Powder Free, Green Color
• Intended Use/Indications for Use: "A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner."
• Regulatory Class: I
• Product Code: LYZ

Information NOT available in this document:

This document is a marketing clearance for a simple medical device (gloves) and therefore does not include the kind of detailed performance study information typically associated with AI/CAD devices. Specifically, it does not contain:

1. A table of acceptance criteria and reported device performance (in terms of sensitivity, specificity, etc., as would be expected for an AI/CAD system).
2. Sample size used for a test set or data provenance (country, retrospective/prospective).
3. Number of experts, their qualifications, or methods to establish ground truth for a test set.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm-only) performance results.
7. Type of ground truth used (pathology, expert consensus, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

To answer your request, if this were an AI/CAD device, the 510(k) submission itself (which this letter refers to) would contain the study details you are looking for, not the approval letter. For devices like these gloves, the "performance" is generally assessed against established manufacturing standards (e.g., tensile strength, barrier integrity, dimensions, biocompatibility) rather than diagnostic accuracy metrics.

Regulation Number and Section

§ 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.