Search Results
Found 1 results
510(k) Data Aggregation
K Number
K030994Manufacturer
Date Cleared
2003-06-12
(76 days)
Product Code
Regulation Number
880.6250Type
TraditionalPanel
General HospitalReference & Predicate Devices
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 purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Device Description
NON-STERILE ORANGE COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS AND WITH A PROTEIN LABELING CLAIM (
AI/ML Overview
Here's a summary of the acceptance criteria and the study details for the Non-Sterile Orange Colored Powdered Latex Patient Examination Gloves, based on the provided document:
Acceptance Criteria and Device Performance
The device, "Non-Sterile Orange Colored Powdered Latex Patient Examination Gloves with & without Orange/Vanilla Scents and with a Protein Labeling Claim (
Ask a Question
Ask a specific question about this device
Page 1 of 1