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510(k) Data Aggregation
K Number
K022530Device Name
POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LESS)
Manufacturer
Date Cleared
2002-08-26
(26 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HYCARE INTL. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
POWDERED LATEX EXAM GLOVES, WITH PROTEIN LABELING (200 ug/g or less)
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K Number
K020042Device Name
HYCARE LATEX EXAMINATION GLOVE, POWDER FREE
Manufacturer
Date Cleared
2002-07-30
(204 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HYCARE INTL. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
POWDER-FREE LATEX EXAM GLOVES, WITH PROTEIN LABELING (50 ug/g or less)
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K Number
K010875Device Name
HYCARE LATEX EXAMINATION GLOVE, POWDERED
Manufacturer
Date Cleared
2001-06-07
(76 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HYCARE INTL. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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