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510(k) Data Aggregation
K Number
K091942Manufacturer
Date Cleared
2009-09-21
(83 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 purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Device Description
Patient Vinyl Examination Gloves, Powderfree, Non-Sterile
AI/ML Overview
The provided document is a 510(k) premarket notification letter from the FDA regarding Patient Vinyl Examination Gloves. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information.
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