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510(k) Data Aggregation
K Number
K102902Device Name
RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR
Manufacturer
Date Cleared
2011-04-22
(204 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
RUBBERCARE PROTECTION PRODUCTS 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.
Device Description
It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. It is particularly suitable to users who prefer a powder-free work environment or who may be sensitive or allergic to the powdered version of the same gloves.
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K Number
K103661Device Name
RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE
Manufacturer
Date Cleared
2011-03-23
(97 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
RUBBERCARE PROTECTION PRODUCTS 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.
Device Description
Powder Free Nitrile Examination Glove, White (non-colored) or Blue (Colored)
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