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510(k) Data Aggregation
K Number
K032781Device Name
BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Date Cleared
2003-11-13
(66 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**ZIBO BLUE SAIL PLASTIC **& RUBBER PRODUCTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free vinyl 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 vinyl patient examination gloves, white (non-colored) that meets all of the requirements of ASTM standard D 5250-0084.
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K Number
K032783Device Name
BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
Date Cleared
2003-11-13
(66 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**ZIBO BLUE SAIL PLASTIC **& RUBBER PRODUCTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powdered vinyl 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
powdered vinyl patient examination gloves, white (non-colored) that meets all of the requirements of ASTM standard D 5250-004.
Ask a Question
Ask a specific question about this device
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