MULTIPLE PRIVATE LABELS VINYL EXAMINATION GLOVES, POWDER-FREE

• K Number: K023235
• Device Name: MULTIPLE PRIVATE LABELS VINYL EXAMINATION GLOVES, POWDER-FREE
• Manufacturer: SHANDONG JIAZHAN PLASTIC PRODUCTS CO., LTD.
• Date Cleared: 2002-10-18 ( 21 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 purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

VINYL EXAMINATION GLOVES, POWDER-FREE

AI/ML Overview

This appears to be a 510(k) clearance letter from the FDA for Vinyl Examination Gloves, Powder-Free. This type of document does not contain the information requested in your prompt regarding acceptance criteria and study details.

The provided text simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and contact information for the applicant.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe specific performance criteria or test results.
2. Sample size used for the test set and the data provenance: No device testing details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth or expert review details are provided.
4. Adjudication method for the test set: Not applicable as no test set details are 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: This is a medical glove, not an AI diagnostic device, so an MRMC study is not relevant and not discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an algorithm.
7. The type of ground truth used: No ground truth details are provided.
8. The sample size for the training set: Not applicable as this is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable as this is not a machine learning device.

The 510(k) process for devices like examination gloves primarily relies on demonstrating substantial equivalence to existing predicate devices, often through adherence to recognized standards (e.g., ASTM standards for glove performance). The detailed testing reports supporting this substantial equivalence are typically submitted by the manufacturer to the FDA but are not generally part of the publicly released 510(k) clearance letter itself.

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.