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510(k) Data Aggregation
K Number
K042214Device Name
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES
Manufacturer
Date Cleared
2004-09-15
(30 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANDONG PERFECT PLASTIC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder-free patient examination glove is a disposable device intended for medical purpose that is worn upon the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder-Free Vinyl Non-Sterile Examination Glove
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K Number
K042213Device Name
PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES
Manufacturer
Date Cleared
2004-09-09
(24 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANDONG PERFECT PLASTIC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A pre-powdered patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
Device Description
Pre-Powdered Vinyl Non-sterile Examination Glove
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Ask a specific question about this device
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