K Number
K013333
Date Cleared
2001-12-07

(59 days)

Product Code
Regulation Number
880.6250
Panel
HO
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

A patient examination glove is a disposable device intended for medical purpose than worn on the examiner's hands or fingers to prevent contamination between patient ar. examiner. (21 CER 880.6250)

Device Description

LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM ( 50 MICROGRAMS OF LESS)

AI/ML Overview

This document is a 510(k) clearance letter for latex examination gloves. It does not contain information about the acceptance criteria or a study that proves a device meets such criteria for an AI/ML-driven medical device. Therefore, I cannot extract the requested information.

§ 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.