POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED

• K Number: K031625
• Device Name: POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED
• Manufacturer: PERUSAHAAN GETAH ASAS SDN BHD
• Date Cleared: 2003-08-01 ( 66 days)
• Product Code: LZA
• 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

Powder-free Barrier-Pro™ Co-polymer Patient Examination Clove, White (non-colored) or Green colored. Note: (a) Glove made from Synthetic Butadiene Methylmetacrylate Mcthacrylic Acid Co-polymer Rubber (h)Barrier-ProTM is a registered trade mark of Dow Reichhold Specialty Latex LLC

AI/ML Overview

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for a "Powder-free Barrier-Pro™ Co-Polymer Examination Glove." This document is a regulatory approval for a medical device and does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/software-as-a-medical-device (SaMD) products.

The 510(k) process for this type of device (a Class I patient examination glove) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, primarily through adherence to general controls (e.g., manufacturing practices, labeling) rather than specific performance metrics derived from clinical studies in the way an AI algorithm would be evaluated.

Therefore, I cannot extract the requested information points because they are not present in this type of regulatory document for this type of medical device.

To directly answer your request based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states a "substantial equivalence determination" was made, but no specific performance criteria or results are listed.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method: Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable and not provided. This is a physical medical device (glove), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable and not provided. This is a physical medical device.
7. The type of ground truth used: Not applicable and not provided.
8. The sample size for the training set: Not applicable and not provided.
9. How the ground truth for the training set was established: Not applicable and not provided.

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.