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Found 8 results
510(k) Data Aggregation
K Number
K994246Device Name
OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
Manufacturer
Date Cleared
2000-01-31
(46 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
OMNIGRACE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is wom on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
OmniGrace Nitrile, Blue, Examination Glove, Powder Free, Polymer Coated.
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K Number
K993419Device Name
OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
1999-11-19
(38 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
OMNIGRACE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
OmniGrace Latex Examination Glove, Powder Free, Polymer Coated, with Protein Claim (50 Micrograms or Less)
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K Number
K993050Device Name
OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
Manufacturer
Date Cleared
1999-11-09
(60 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
OMNIGRACE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
OmniGrace Nitrile, Green, Examination Glove, Powder Free, Polymer Coated.
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K Number
K991845Device Name
PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE.
Manufacturer
Date Cleared
1999-08-05
(69 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
OMNIGRACE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
Not Found
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K Number
K991846Device Name
PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE
Manufacturer
Date Cleared
1999-08-05
(69 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
OMNIGRACE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
Patient Examination Glove, Nitrile, Powdered, Turquoise
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K Number
K983730Device Name
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE
Manufacturer
Date Cleared
1998-12-11
(50 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
OMNIGRACE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent / moundal you between health care personnel and the patient.
Device Description
Omni Flex Nitrile Examination Glove, Powder Free, Blue
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K Number
K983725Device Name
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE
Manufacturer
Date Cleared
1998-12-07
(46 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
OMNIGRACE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is wom on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
Omni Touch Nitrile Examination Glove, Powdered, Blue
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K Number
K973134Device Name
OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED
Manufacturer
Date Cleared
1997-11-06
(77 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
OMNIGRACE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Device Description
Patient Examination Glove - Om Ni. FIT , LATEx TownEzFil EXAMINATION GLOVE.
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