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510(k) Data Aggregation
K Number
K973830Device Name
POWDER FREE PATIENT EXAMINATION GLOVE SAFE GLOVE
Manufacturer
Date Cleared
1998-01-16
(101 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SAFE GLOVE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
According to 21 CFR, 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
POWDER FREE LATEX PATIENT EXAMINATION GLOVES
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K Number
K973831Device Name
PRE-POWDERED PATIENT EXAMINATION GLOVE
Manufacturer
Date Cleared
1998-01-06
(91 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SAFE GLOVE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
According to 21 CFR, a patient examination glove is a disposable device intended for medical purpose that is worn on the examiner 's hand or finger to prevent contamination between patient and examiner.
Device Description
PRE POWDERED LATEX PATIENT EXAMINATION GE
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