Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile

• K Number: K220429
• Device Name: Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile
• Manufacturer: One Glove Industrial SDN BHD
• Date Cleared: 2022-05-13 ( 87 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 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

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device: Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile.

This type of device (patient examination gloves) does not typically involve complex algorithms or AI. Therefore, the typical performance metrics associated with AI/ML devices (like sensitivity, specificity, AUC, human reader studies, etc.) along with the specific ground truth establishment and training set details, are not relevant or applicable to this document. The FDA clearance for such devices is based on demonstrating substantial equivalence to a predicate device and complying with general controls.

The performance criteria for examination gloves generally revolve around physical properties and barrier integrity, usually assessed through standardized tests defined in specifications like ASTM standards.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they pertain to an AI/ML device. The provided document does not contain information on:

• A table of acceptance criteria and reported device performance related to AI/ML metrics.
• Sample sizes, data provenance, number of experts, adjudication methods for a test set.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• Type of ground truth, training set size, or how ground truth was established for a training set (as these are unique to AI/ML device development).

The document is a regulatory approval letter, not a clinical study report or a technical performance evaluation report for an AI-powered diagnostic device.

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.