POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE

• K Number: K030200
• Device Name: POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE
• Manufacturer: KAOHSIUNG BROTHERS PRODUCTS CORP.
• Date Cleared: 2003-03-20 ( 58 days)
• Product Code: LYZ
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Device Description

Powdered Synthetic Vinyl Patient Examination Gloves, White

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding "Powdered Synthetic Vinyl Patient Examination Gloves, White." This type of submission is for medical devices that are substantially equivalent to already legally marketed devices and does not typically involve the detailed performance studies or AI validation often seen with more novel devices or software as a medical device (SaMD).

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving device performance as typically expected for an AI/ML-based medical device.

The document is purely an administrative notification of "substantial equivalence" for a physical medical glove. It confirms that the gloves meet the general controls provisions of the Act but does not delve into specific performance metrics or studies in the way an AI-driven device would.

To directly answer your numbered points based only on the provided text, most items are not applicable or cannot be found:

1. A table of acceptance criteria and the reported device performance: Not present. This document is about regulatory approval for substantial equivalence, not a performance study report.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
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 (this is not an AI device).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable (this is not an AI device).
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

In summary, the provided document is a regulatory clearance letter for a non-AI physical medical device (gloves) and therefore does not contain the kind of technical performance study details you are asking for, which are typically relevant for AI/ML medical devices.

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.