NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES

• K Number: K022572
• Device Name: NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES
• Manufacturer: AR ALLIANCE HEALTHCARE SDN. BHD.
• Date Cleared: 2002-11-08 ( 98 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 medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for medical gloves, and it does not contain the type of information requested in the prompt. The request asks for details about a study and acceptance criteria for a device, which typically refers to a diagnostic or therapeutic device whose performance is measured against specific metrics.

This document, however, is solely about the regulatory clearance of "NITRI GRIP Powdered Nitrile Examination Gloves" and confirms their substantial equivalence to predicate devices, thus allowing them to be marketed. It does not include:

• A table of acceptance criteria and device performance.
• Details about a test set (sample size, data provenance, ground truth experts, adjudication).
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Details on a training set or how ground truth for training was established.

The "Indications for Use" section (page 2) simply states the purpose of the gloves, which is to prevent contamination between healthcare personnel and patients, not a performance metric for which a study with acceptance criteria would be conducted in the context of the prompt's questions.

Therefore, I cannot fulfill the request based on the provided 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.