ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

• K Number: K020838
• Device Name: ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
• Manufacturer: AR ALLIANCE HEALTHCARE SDN. BHD.
• Date Cleared: 2002-04-23 ( 40 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• 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

POWDERED FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MIGROGRAM OR LESS).

AI/ML Overview

This document is a 510(k) clearance letter for "Ultra Touch Powder-Free Latex Examination Gloves With Protein Labeling Claim (50 Micrograms or Less)". It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

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.