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510(k) Data Aggregation
K Number
K042028Device Name
VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE
Manufacturer
Date Cleared
2004-08-09
(12 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**ZIBO BORUI 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 patient and examiner. (21CFR 880.6250)
Device Description
Powder Free Vinyl Examination Gloves
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K Number
K040828Device Name
DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2004-04-19
(19 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**ZIBO BORUI PLASTIC **& RUBBER PRODUCTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powdered Vinyl Patient Examination Gloves
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Ask a specific question about this device
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