Search Results
Found 1 results
510(k) Data Aggregation
K Number
K040532Date Cleared
2004-03-23
(22 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 gloves 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 Vinyl Synthetic Examination Gloves, White Color (Sensi-Pro)
AI/ML Overview
This document is a marketing authorization letter for Powder Free Vinyl Synthetic Examination Gloves. It does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.
Therefore, I cannot provide the requested information.
Ask a Question
Ask a specific question about this device
Page 1 of 1