FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Powder Free Latex Examination Gloves with Protein Content Labeling Claim of 50 micrograms or less.

AI/ML Overview

This document set is a 510(k) premarket notification letter from the FDA, approving a medical device. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The provided text is regulatory correspondence, not a technical study report.

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

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K Number

K954416

Device Name

POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES

Manufacturer

HARTALEGA SDN BHD

Date Cleared

1996-10-11

(386 days)