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510(k) Data Aggregation
K Number
K984125Device Name
POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
Manufacturer
Date Cleared
1999-02-09
(83 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
KILANG BARANGAN GETAH DIOH
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
Powdered Latex Examination Gloves
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K Number
K984127Device Name
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
Manufacturer
Date Cleared
1999-01-25
(68 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
KILANG BARANGAN GETAH DIOH
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
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
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Ask a specific question about this device
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