POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

• K Number: K994354
• Device Name: POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
• Manufacturer: FLEXITECH SDN. BHD.
• Date Cleared: 2000-01-31 ( 39 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• 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

Polymer Coated, Powder Free, Latex Examination Gloves WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LES

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, specifically concerning "Latex Examination Glove, Polymer Coated." It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is a regulatory approval letter and an "Indication for Use Statement" for the glove.

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

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.