Search Results
Found 14 results
510(k) Data Aggregation
K Number
K041745Device Name
VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
Manufacturer
Date Cleared
2004-07-15
(17 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
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 the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Vinyl Examination Gloves, Powder Free, Green Color
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K Number
K031944Device Name
VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR
Manufacturer
Date Cleared
2003-09-23
(91 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
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 the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Vinyl Examination Gloves, Powder Free, Pink Color
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K Number
K031913Device Name
VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR
Manufacturer
Date Cleared
2003-07-09
(19 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
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 the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Vinyl Examination Gloves, Powder Free, Violet Color
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K Number
K030245Device Name
NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR
Manufacturer
Date Cleared
2003-04-04
(70 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
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 the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Nitrile Examination Gloves, Powder Free Polymer Coated, Purple Color
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K Number
K023754Device Name
VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E
Manufacturer
Date Cleared
2003-03-25
(139 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
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 the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Vinyl Examination Gloves, Powder Free, with Vitamin E
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K Number
K023072Device Name
POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR
Manufacturer
Date Cleared
2003-02-13
(150 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
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 the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Nitrile Examination Gloves, Purple Color
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K Number
K022987Device Name
LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
Manufacturer
Date Cleared
2002-10-21
(42 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
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 the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Latex Examination Gloves, Powdered Contains 180 mcgm or less of Total Water Extractable Protein per gram.
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K Number
K021412Device Name
LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED
Manufacturer
Date Cleared
2002-06-07
(35 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
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 the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Latex Examination Gloves, Powder Free, Polymer Coated
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K Number
K013320Device Name
BLUE LATEX EXAMINATION GLOVES, POWDER FREE
Manufacturer
Date Cleared
2001-12-19
(75 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
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 the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Blue Latex Examination Gloves, Powder Free
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K Number
K002745Device Name
VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR
Manufacturer
Date Cleared
2000-10-12
(37 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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