UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE)

• K Number: K982611
• Device Name: UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE)
• Manufacturer: UNIJECT GLOVES PCL
• Date Cleared: 1998-11-02 ( 129 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

An Examination Gloves 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

UNIJECT EXAMINATION GLOVES POWDER FREE

AI/ML Overview

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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.