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510(k) Data Aggregation
K Number
K041325Manufacturer
Date Cleared
2004-07-02
(45 days)
Product Code
Regulation Number
880.6250Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREE
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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Device Description
DISPOSABLE VINYL SYNTHETIC EXAM GLOVE, POWDER FREE, PINK COLOR
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for disposable vinyl synthetic exam gloves. It does not contain information about acceptance criteria and a study proving device performance as requested. The letter is a regulatory approval, not a scientific study report. Therefore, I cannot extract the requested information from the provided text.
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