ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM

• K Number: K030331
• Device Name: ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM
• Manufacturer: PERUSAHAAN GETAH ASAS SDN BHD
• Date Cleared: 2003-03-21 ( 49 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended 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.

Device Description

On-line Powder-free Latex Patient Examination Gloves, Type II, Low Modulus with Extractable Protein Content Labeling Claim (50 Micrograms per gram or less)

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for a medical device: "On-line Powder-free Latex Patient Examination Gloves, Type II, Low Modulus with Extractable Protein Content Labeling Claim (50 Micrograms per gram or less)".

This document is a regulatory approval and does not describe a study to prove the device meets acceptance criteria in the way envisioned by the request. The request asks for details about a study to evaluate "device performance" in terms of metrics like accuracy, effect size with AI assistance, and ground truth establishment, which are typical for diagnostic or AI-powered devices.

For a patient examination glove, the "acceptance criteria" and "study" would refer to manufacturing standards, chemical composition, biocompatibility, physical properties (e.g., tensile strength, elongation), and extractable protein content. The approval letter confirms that the device is "substantially equivalent" to a legally marketed predicate device, meaning it meets the same safety and effectiveness standards.

Therefore, I cannot fulfill the request as formatted because the provided document does not contain the information required to populate the requested table and answer the study-specific questions. There is no information on:

1. A table of acceptance criteria and reported device performance in the context of an accuracy study.
2. Sample sizes for test sets, data provenance, or retrospective/prospective nature.
3. Number and qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness study or human reader improvement with AI.
6. Standalone performance of an algorithm.
7. Type of ground truth used (e.g., pathology, outcomes).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory confirmation of substantial equivalence for a physical medical product, not a clinical or performance study report for a diagnostic or AI device.

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.