Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile

• K Number: K220431
• Device Name: Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile
• Manufacturer: One Glove Industrial Sdn Bhd
• Date Cleared: 2022-06-17 ( 122 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A Nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

BLUE NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE, NON STERILE

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile. It is a regulatory clearance for a medical device and, as such, does not contain the type of information typically found in acceptance criteria or study results for AI/ML-based medical devices.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance: This document is not for an AI/ML device, so no such performance data is present.
2. Sample size used for the test set and the data provenance: Not applicable to a physical glove.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
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 (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document discusses the regulatory process for this type of Class I, reserved medical device, referencing general controls, good manufacturing practices, labeling requirements, and reporting of adverse events. It explicitly states the "Indications for Use" for the glove: "A Nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a description of the intended use of a physical product, not a software algorithm.

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.