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510(k) Data Aggregation
K Number
K023072Manufacturer
Date Cleared
2003-02-13
(150 days)
Product Code
Regulation Number
880.6250Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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 Nitrile Examination Gloves, Purple Color
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for Powder Free Nitrile Examination Gloves. It primarily addresses regulatory approval and does not contain information on acceptance criteria, device performance, or study details as typically found in a clinical or performance validation report. Therefore, I cannot provide the requested information.
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