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510(k) Data Aggregation
K Number
K091422Device Name
NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)
Manufacturer
Date Cleared
2009-07-30
(78 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NOVAPRO CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Stretch Vinyl examination glove(Yellow/white) 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, Stretch Vinyl Examination Gloves, Yellow/White
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K Number
K091421Device Name
NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED)
Manufacturer
Date Cleared
2009-07-23
(71 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NOVAPRO CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Vinyl examination glove, Powder Free, Clear(Non-Colored)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, Vinyl Examination Gloves, Clear (Non-Colored)
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