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510(k) Data Aggregation
K Number
K062955Device Name
POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
Manufacturer
Date Cleared
2006-11-09
(41 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. HALONI JANE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder free Latex Examination Gloves
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