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510(k) Data Aggregation
K Number
K073447Device Name
SURGI GLOVES
Manufacturer
Date Cleared
2008-04-24
(139 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
METACURE SURGICAL GLOVES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder free nitrile surgical glove is a disposable device intended to be worn on the hands by operating room personnel to provide a barrier against potentially infectious materials and other contaminants.
Device Description
Sterile Powder Free Nitrile Surgical Gloves
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K Number
K072197Device Name
POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR
Manufacturer
Date Cleared
2008-03-12
(218 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
METACURE SURGICAL GLOVES SDN BHD
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. Gloves that have been tested for use with chemotherapy drugs are not intended to be used as a chemical barrier.
Device Description
Powderfree Blue Latex Examination Gloves – Tested For Use With Chemotherapy Drugs; Powderfree Natural Latex Examination Gloves - Not Tested For Use With Chemotherapy Drugs
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