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Found 6 results
510(k) Data Aggregation
K Number
K041945Device Name
POWDER-FREE BLUE VINYL EXAM GLOVES
Manufacturer
GLORMED INTL., INC.
Date Cleared
2004-08-20
(32 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GLORMED INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 BLUE VINYL EXAM GLOVES
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K Number
K031104Device Name
POWDERED VINYL EXAM GLOVES, WHITE
Manufacturer
GLORMED INTL., INC.
Date Cleared
2003-06-10
(64 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GLORMED INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 VINYL EXAM GLOVES, WHITE
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K Number
K021353Device Name
POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE
Manufacturer
GLORMED INTL., INC.
Date Cleared
2002-06-06
(41 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GLORMED INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 POLY-VINYL EXAMINATION GLOVES, COLOR: WHITE
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K Number
K002340Device Name
VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW
Manufacturer
GLORMED INTL., INC.
Date Cleared
2000-08-22
(21 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GLORMED INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983494Device Name
VINYL EXAM GLOVES, POWDER FREE
Manufacturer
GLORMED INTL., INC.
Date Cleared
1998-11-05
(31 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GLORMED INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This powder-free vinyl exam glove is intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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
The device is powder-free vinyl exam gloves. They are non-sterile, single use, disposable gloves.
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K Number
K981360Device Name
VINYL PATIENT EXAMINATION GLOVE, POWDERED
Manufacturer
GLORMED INTL., INC.
Date Cleared
1998-10-15
(184 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GLORMED INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Vinyl Patient Examination Glove, Powdered
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