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510(k) Data Aggregation
K Number
K003232Manufacturer
Date Cleared
2000-10-26
(9 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
Device Description
AI/ML Overview
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K Number
K990963Manufacturer
Date Cleared
1999-05-26
(64 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 hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
RS Nitrilstat Medical Examination Gloves, Powder Free (Non-Sterile)
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about the acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot provide the requested information based on the given input.
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