POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED

• K Number: K024184
• Device Name: POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED
• Manufacturer: PERUSAHAAN GETAH ASAS SDN BHD
• Date Cleared: 2003-01-14 ( 26 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• 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

Powder-free coated Nitrile Patient Examination Glove, Blue Color

AI/ML Overview

This document is a 510(k) premarket notification for a medical device: "Powder-Free Coated Nitrile Patient Examination Glove, Blue Color." It is a regulatory clearance letter from the FDA.

Based on the provided text, there is no information available about acceptance criteria or a study proving the device meets acceptance criteria.

The document states that the FDA reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. This means the device is considered as safe and effective as a device already on the market. However, the letter itself does not contain the details of the performance testing, acceptance criteria, or the study design.

Therefore, for each of your requested points, the answer is: Not applicable or not provided in this document.

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample sized 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 for the test set: 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 (this device is a patient examination glove, not an AI or imaging device).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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.