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510(k) Data Aggregation
K Number
K981963Device Name
SENSITEX EXAMINATION GLOVE
Manufacturer
Date Cleared
1998-07-24
(50 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
OAK CAROLINA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner
Device Description
This device is a powder free vinyl examination glove.
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K Number
K981488Device Name
GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION
Manufacturer
Date Cleared
1998-07-07
(71 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
OAK CAROLINA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A 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
This device is a powder free vinyl examination glove.
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K Number
K952050Device Name
GLOVE, EXAMINATION, VINYL
Manufacturer
Date Cleared
1996-08-12
(469 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
OAK CAROLINA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Their intended use is to prevent an interchange of body fluids via the hands of the wearer and the person (patient) being examined. Specifically, they are designed to prevent blood or other body fluids from the hands of the wearer from being transferred to the examinee. Also they are designed to prevent body fluids from the examinee from being transferred to the wearer via the wearer's hands.
Device Description
Oak Carolina examination gloves are made from poly vinyl chloride (vinyl). They are to be marketed under the trade name Sensi-tex.
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