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Found 4 results
510(k) Data Aggregation
K Number
K013821Device Name
SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
2002-03-05
(109 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP QUALITY MFG., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes worn A patient examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Silk Touch Powdered Latex Examination Glove with Protein Content Labeling Claim ( 200 Micrograms or Less )
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K Number
K013254Device Name
POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
2002-02-04
(129 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP QUALITY MFG., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Top Quality Skingard Polycoat Powdered Latex Examination Glove with Aloe Vera is intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powdered Latex Examination Glove with Aloe Vera
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K Number
K004018Device Name
SKINGARD POLYCOAT GLOVE
Manufacturer
Date Cleared
2001-05-11
(135 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP QUALITY MFG., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K000050Device Name
TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES
Manufacturer
Date Cleared
2000-07-27
(202 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP QUALITY MFG., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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