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510(k) Data Aggregation
K Number
K003063Device Name
GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTIONManufacturer
Date Cleared
2000-11-22
(51 days)
Product Code
Regulation Number
878.4460Type
TraditionalPanel
Hematology (HO)Reference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
GIMBEL GLOVE CO., LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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