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510(k) Data Aggregation
K Number
K970160Device Name
UNIJECT SURGICAL GLOVES
Manufacturer
Date Cleared
1997-07-15
(180 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
UNIJECT GLOVES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A surgeon's glove is device made of natural or synthetic rubber intended to be worn by the operating room personnel to protect a surgical wound from contamination.
Device Description
A surgeon's glove is device made of natural or synthetic rubber intended to be worn by the operating room personnel to protect a surgical wound from contamination.
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K Number
K970191Device Name
UNIJECT EXAMINATION GLOVES
Manufacturer
Date Cleared
1997-07-03
(168 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
UNIJECT GLOVES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination gloves 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
Not Found
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