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Found 5 results
510(k) Data Aggregation
K Number
K103650Device Name
NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM
Manufacturer
Date Cleared
2011-03-23
(99 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
OON CORP. RESOURCES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Powder-Free Patient Examination Glove is a 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
Non-Sterile, Powder-Free Blue Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or less) Non-Sterile, Powder-Free Blue Latex Examination Gloves with Bubble Gum Scent and Protein Labeling Claim (50 Micrograms or less) Non-Sterile, Powder-Free Blue Latex Examination Gloves with Grape Scent and Protein Labeling Claim (50 Micrograms or less)
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K Number
K093496Device Name
NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT
Manufacturer
Date Cleared
2010-02-03
(85 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
OON CORP. RESOURCES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVE WITH AND/OR WITHOUT STRAWBERRY SCENT, AND WITH PROTEIN LABELING CLAIM (50 micrograms or less) IS A 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
NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES, WITH AND/OR WITHOUT STRAWBERRY SCENT, AND WITH PROTEIN CONTENT LABELING CLAIM (50 Micrograms or Less)
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K Number
K002448Device Name
LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM).
Manufacturer
Date Cleared
2000-09-11
(33 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
OON CORP. RESOURCES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K981917Device Name
POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
1998-12-07
(189 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
OON CORP. RESOURCES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IS A PATIENT EXAMINATION GLOVE WHICH IS A DISPOSABLE MEDICAL DEVICE INTENDED FOR MEDICAL PURPOSES THAT ARE WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Device Description
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT (50 MICROGRAMS OR LESS)
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K Number
K970770Device Name
LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
1997-07-14
(133 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
OON CORP. RESOURCES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IS A PATIENT EXAMINATION GLOVE WHICH IS A DISPOSABLE MEDICAL DEVICE INTENDED FOR MEDICAL PURPOSES THAT ARE WORN ON-THE EXAMINER*S WAND TO PREVENT CONTAMINATION™ BETWEEN PATIENT AND EXAMINER.
Device Description
POWDER-FREE LATEX EXAMINATION GLOVES
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