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Found 6 results
510(k) Data Aggregation
K Number
K024338Device Name
POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE
Manufacturer
Date Cleared
2003-03-03
(66 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GENERAL GLOVES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A vinyl 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 VINYL EXAM GLOVES WITH ALOE COATING INSIDE
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K Number
K024174Device Name
NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES
Manufacturer
Date Cleared
2003-01-28
(41 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GENERAL GLOVES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A vinyl 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 VINYL EXAMINATION GLOVES
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K Number
K010830Device Name
POWDER FREE TEXTURED VINYL EXAMINATION GLOVES
Manufacturer
Date Cleared
2001-04-09
(20 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GENERAL GLOVES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K010829Device Name
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
Manufacturer
Date Cleared
2001-04-05
(16 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GENERAL GLOVES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K992107Device Name
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES
Manufacturer
Date Cleared
1999-08-23
(62 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GENERAL GLOVES CORP.
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
Class 1 vinyl patient examination glove 80LYZ, powdered, that meets all the requirements of ASTM D 5250 - 92.
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K Number
K982933Device Name
VINYL EXAMINATION GLOVES, POWDER FREE
Manufacturer
Date Cleared
1998-11-06
(78 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GENERAL GLOVES CORP.
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
Class 1 vinyl patient examination glove 80LYZ, powder-free, that meets all the requirements of ASTM D 5250 - 92.
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