Powder Free Blue Nitrile Examination Glove

• K Number: K153562
• Device Name: Powder Free Blue Nitrile Examination Glove
• Manufacturer: Viet Glove Corporation
• Date Cleared: 2016-04-01 ( 109 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: K201428 , K210369 , K210375

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 BLUE NITRILE EXAMINATION GLOVE

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a 'Powder Free Blue Nitrile Examination Glove'. It primarily deals with the regulatory approval of a medical device (a glove), determining its substantial equivalence to previously marketed devices.

The request asks for information related to acceptance criteria and a study proving a device meets those criteria, specifically within the context of an AI/algorithm-based medical device study.

This document does not contain the information requested.

Specifically:

• It is not about an AI/algorithm-based medical device.
• It does not describe acceptance criteria for an algorithm's performance (e.g., sensitivity, specificity, AUC). Instead, it's about the regulatory acceptance of a physical medical device (gloves).
• It does not describe a study involving test sets, training sets, ground truth establishment by experts, or MRMC studies. The documentation for mechanical properties, biocompatibility, or other performance characteristics of the glove would be in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot extract the requested information from this document.

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.