NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT

• K Number: K101351
• Device Name: NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT
• Manufacturer: ASCEND EAGLE, INC.
• Date Cleared: 2010-10-15 ( 154 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

These Non-Sterile, Powder-Free Peach Color, Nitrile Examination Gloves with Lano-E and Peppermint Citrus Scent, are a disposable (single-use-only) device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Non-Sterile, Powder-Free PEACH Color, Nitrile Examination Gloves with Lano-E and Peppermint Citrus Scent

AI/ML Overview

This document is a 510(k) premarket notification approval letter for examination gloves. It does not contain information regarding software or AI/ML acceptance criteria or a study proving device performance against such criteria. Therefore, I cannot provide the requested information.

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.