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510(k) Data Aggregation
K Number
K103337Device Name
MULTIPLE NAME
Manufacturer
Date Cleared
2011-02-25
(102 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
IDEAL QUALITY SDN., BHD.
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 to prevent contamination between patient and examiner.
Device Description
Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile will meet all the current specification for ASTM D6319.
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K Number
K981062Device Name
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
1998-06-01
(70 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
IDEAL QUALITY SDN., BHD.
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 Examination Gloves Polymer Coated with Protein Content Labeling Claim (100 Micrograms or Less)
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K Number
K974660Device Name
LATEX EXAMINATION GLOVE
Manufacturer
Date Cleared
1998-04-02
(108 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
IDEAL QUALITY SDN., BHD.
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
Latex Examination Gloves, Powdered
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K Number
K974662Device Name
POWDER-FREE LATEX EXAMINATION GLOVE
Manufacturer
Date Cleared
1998-04-02
(108 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
IDEAL QUALITY SDN., BHD.
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 Patient Examination Glove
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