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510(k) Data Aggregation
K Number
K014284Device Name
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE
Manufacturer
Date Cleared
2002-02-15
(50 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
FORMOSA GLOVE INDUSTRIAL CO., LTD.
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 hand or finger to prevent contamination between patient and examiner.
Device Description
Nitrile Patient Examination Glove, Powder-free and yellowish white
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K Number
K014285Device Name
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE
Manufacturer
Date Cleared
2002-02-14
(49 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
FORMOSA GLOVE INDUSTRIAL CO., LTD.
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 hand or finger to prevent contamination between patient and examiner.
Device Description
Purple Nitrile Patient Examination Glove, Powder-free
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K Number
K992588Device Name
BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
Manufacturer
Date Cleared
1999-09-10
(39 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
FORMOSA GLOVE INDUSTRIAL CO., LTD.
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 hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General and Plastic Device Panel as Class I (21 CFR 880,6250), nitrile patient examination gloves, powder-free, 80 LZA. Meets all requirements of ASTM D5250, Standard for poly(vinyl chloride) gloves for medical application. Also meets all requirement of ASTM D3578, Standard for rubber examination gloves except for ultimate elongation before aging.
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