POWDERED LATEX EXAMINATION GLOVES, NON-STERILE by KHAI HOAN JOINT STOCK COMPANY | FDA 510(k) Summary

FDA 510(k) Search

K Number

Device Name

POWDERED LATEX EXAMINATION GLOVES, NON-STERILE

Manufacturer

KHAI HOAN JOINT STOCK COMPANY

Date Cleared

2010-02-23

(175 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Natural Rubber Late: a non-colored, single use amination ce inte on the hand of med nded to If to prevent contamination between the patie neand examine

Device Description

POWDERED LATEX EXAMINATION GLOVES (NON-COLORED)

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for Powdered Latex Examination Gloves (Non-Colored). It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The document is a regulatory communication confirming that the device is substantially equivalent to legally marketed predicate devices. It outlines general controls, manufacturing practices, and reporting requirements for the device.

Therefore, I cannot provide the requested information based on the given input text.

Summary

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.