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Found 3 results
510(k) Data Aggregation
K Number
K070404Device Name
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
Manufacturer
TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD.
Date Cleared
2007-03-26
(42 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Powder Free Blue Patient Nitrile Examination Gloves 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 Blue Patient Nitrile Examination Gloves that meets all of the requirements of ASTM D 6139-05
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K Number
K061659Device Name
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Manufacturer
TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD.
Date Cleared
2006-09-15
(95 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00"4.
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K Number
K061662Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Manufacturer
TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD.
Date Cleared
2006-09-15
(95 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed.
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