NITRILE POWDER-FREE UNISEAL GLOVES

• K Number: K982218
• Device Name: NITRILE POWDER-FREE UNISEAL GLOVES
• Manufacturer: AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD
• Date Cleared: 1998-11-30 ( 159 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

UNISEAL POWDER-FREE NITRILE EXAMINATION GLOVES

AI/ML Overview

I'm sorry, but this document contains a letter from the FDA regarding the substantial equivalence of Uniseal Nitrile Powder-Free Examination Gloves to a predicate device. It does not contain information about acceptance criteria and a study proving a device meets those criteria, as requested in your prompt. The document is a regulatory notification, not a performance study report.

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.