MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX

• K Number: K022815
• Device Name: MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX
• Manufacturer: PT. SMART GLOVE INDONESIA
• Date Cleared: 2003-02-13 ( 171 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: 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

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for medical examination gloves and does not contain information about the acceptance criteria or study details for a device's performance. 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.