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510(k) Data Aggregation
K Number
K972801Device Name
ALLIANCE RUBBER, EC-GRIPManufacturer
Date Cleared
1997-10-21
(85 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 medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAM OR LESS)
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for examination gloves. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Therefore, I cannot provide the requested information based on the provided text.
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