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

A Stretch Vinyl examination glove, Powder Free(Clear(Non-Colored)/Yellow/White) 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.

Device Description

Powder-Free, Stretch Vinyl Examination Gloves, Clear (Non-Colored) Yellow/White

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) summary is a letter regarding the substantial equivalence determination for "Powder-Free, Stretch Vinyl Examination Gloves, Clear (Non-Colored) Yellow/White."

This document does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a medical device's performance characteristics. It is strictly a regulatory approval letter for examination gloves.

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

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K Number

K072227

Device Name

VINYL EXAMINATION GLOVE POWDER FREE

Manufacturer

PINNACLE CO., LTD.

Date Cleared

2008-02-15

(189 days)