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510(k) Data Aggregation
K Number
K050450Device Name
SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES
Date Cleared
2005-04-04
(41 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**ZIBO BLUE INTCO PLASTIC **& RUBBER PRODUCTS CO
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 upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Device Description
Patient Vinyl Examination Gloves, Powderfree, Non-Sterile
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K Number
K050455Device Name
SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES
Date Cleared
2005-03-29
(35 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**ZIBO BLUE INTCO PLASTIC **& RUBBER PRODUCTS CO
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 hands or finger to prevent contamination between paties: and examiner (21CFR 880.6250)
Device Description
Patient Vinyl Examination Gloves, Powdered
Ask a Question
Ask a specific question about this device
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