HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM 73.13 MICROGRAMS O

• K Number: K992364
• Device Name: HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM 73.13 MICROGRAMS O
• Manufacturer: PAMITEX INDUSTRIES SDN BHD
• Date Cleared: 1999-09-22 ( 69 days)
• Product Code: LYY , DAT
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Powder-free Latex Examination Glove contains 73.13 micrograms or less of total water-extractable protein per gram of glove.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device, specifically a "Powder-free Latex Examination Glove." It does not contain information about acceptance criteria or a study proving that an AI-powered device meets acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided 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.