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Found 7 results
510(k) Data Aggregation
K Number
K081040Device Name
POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
Manufacturer
Date Cleared
2008-05-20
(39 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SHAMROCK MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A palient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Device Description
Powdered Latex Examination Gloves
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K Number
K052709Device Name
POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE
Manufacturer
Date Cleared
2005-11-08
(40 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SHAMROCK MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder free Latex Examination Gloves
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K Number
K052382Device Name
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Manufacturer
Date Cleared
2005-09-15
(16 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SHAMROCK MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder Free Nitrile Examination Gloves, Blue
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K Number
K030325Device Name
POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM
Manufacturer
Date Cleared
2003-03-28
(56 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SHAMROCK MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free Latex Examination Gloves with Bubblegum Aroma is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder free Latex Examination Gloves with Bubblegum Aroma
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K Number
K030134Device Name
LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE
Manufacturer
Date Cleared
2003-03-25
(70 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SHAMROCK MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Latex Examination Glove Powder Free with Neoprene lined is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Device Description
Latex Examination Gloves Powder Free With Lined.
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K Number
K030560Device Name
POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE
Manufacturer
Date Cleared
2003-03-21
(28 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SHAMROCK MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free Latex Examination Gloves with Grape is disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder free Latex Examination Gloves with Grape is disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
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K Number
K011712Device Name
LATEX EXAMINATION GLOVES- POWDER FREE, BLUE
Manufacturer
Date Cleared
2001-07-17
(43 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SHAMROCK MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder free examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination on examiner's hand: to prevent of ・・・・・・・・・・・・・・・ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ー …… '
Powder free Latex Examination Glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder Free - Latex Examination Gloves
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