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510(k) Data Aggregation
K Number
K030075Device Name
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED)
Manufacturer
BEST MANUFACTURING COMPANY-DISTRIBUTION CENTER
Date Cleared
2003-03-05
(56 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BEST MANUFACTURING COMPANY-DISTRIBUTION CENTER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between the patient and examiner. Powder-free examination gloves are suitable in situations where powder is not desirable.
The Nitrile Powder-Free Medical Examination Glove (blue) is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).
Device Description
Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens.
The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movement necessary for treatment. The absence of natural rubber latex in the product yields no latex protein allergens.
Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids.
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