PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) by FLEXITECH SDN. BHD. | FDA 510(k) Summary

FDA 510(k) Search

K Number

Device Name

PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)

Manufacturer

FLEXITECH SDN. BHD.

Date Cleared

1999-04-02

(44 days)

Product Code

Regulation Number

Type

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

PrePowdered Latex Examination Gloves with Protein claim.

AI/ML Overview

This document is a 510(k) premarket notification approval letter for "Pre-Powdered Latex Examination Gloves" from FLEXITECH SDN. BHD. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the FDA has reviewed the submission and determined the device to be substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information from the provided 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.