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Found 4 results
510(k) Data Aggregation
K Number
K220431Device Name
Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile
Manufacturer
Date Cleared
2022-06-17
(122 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
One Glove Industrial Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
BLUE NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE, NON STERILE
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K Number
K220429Device Name
Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile
Manufacturer
Date Cleared
2022-05-13
(87 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
One Glove Industrial SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Not Found
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K Number
K220427Device Name
White Nitrile Powder-Free Patient Examination Glove, Non Sterile
Manufacturer
Date Cleared
2022-05-10
(84 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
One Glove Industrial SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
WHITE NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE, NON STERILE
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K Number
K220428Device Name
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
Manufacturer
Date Cleared
2022-05-10
(84 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
One Glove Industrial SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
BLACK NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE, NON-STERILE
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