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Found 9 results
510(k) Data Aggregation
K Number
K111158Device Name
LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
2011-08-10
(107 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE GLOVES CO; LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder-free patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner
Device Description
Latex Examination Gloves Powder-Free (Black Color) and with protein content labeling claim(50 micrograms or less)
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K Number
K103670Device Name
NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)
Manufacturer
Date Cleared
2011-03-31
(105 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE GLOVES CO; LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a NON STERILE 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
NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE and BLACK COLOR)
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K Number
K083908Device Name
BLACK NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
2009-03-06
(66 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE GLOVES CO; LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder free patient examination glove is a disposable device made of synthetic Nitrile butadiene rubber later material may bear a trace of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious material and other contaminants.
Device Description
Black Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner.
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K Number
K021668Device Name
NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR)
Manufacturer
Date Cleared
2002-08-12
(83 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE GLOVES CO; LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intend for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
BLUE NITRILE EXAMINATION GLOVES, POWDER FREE.
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K Number
K013333Device Name
LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIM
Manufacturer
Date Cleared
2001-12-07
(59 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE GLOVES CO; LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purpose than worn on the examiner's hands or fingers to prevent contamination between patient ar. examiner. (21 CER 880.6250)
Device Description
LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM ( 50 MICROGRAMS OF LESS)
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K Number
K993567Device Name
INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS]
Manufacturer
Date Cleared
2000-01-12
(83 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE GLOVES CO; LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.
Device Description
Latex Examination Powder Free with proteins content label claim 50 MICROGRAMS OR LESS
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K Number
K993221Device Name
INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDERED
Manufacturer
Date Cleared
1999-11-05
(39 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE GLOVES CO; LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Medical glc ve is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.
Device Description
LATEX EXAMINATION GLOVES, PREPOWDERED
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K Number
K993222Device Name
INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES POWDERFREE
Manufacturer
Date Cleared
1999-11-05
(39 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE GLOVES CO; LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.
Device Description
LATEX EXAMINATION GLOVES, POWDERFREE
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K Number
K993325Device Name
INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE
Manufacturer
Date Cleared
1999-11-05
(32 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE GLOVES CO; LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.
Device Description
NITRILE LATEX EXAMINATION GLOVES, POWDERFREE
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