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Found 3 results
510(k) Data Aggregation
K Number
K082598Device Name
POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE
Manufacturer
TANGSHAN ZHONGHONG PULIN GROUP CO., LTD.
Date Cleared
2009-01-07
(121 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TANGSHAN ZHONGHONG PULIN GROUP 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
Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6319-05
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K Number
K022091Device Name
BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES
Manufacturer
TANGSHAN ZHONGHONG PULIN GROUP CO., LTD.
Date Cleared
2002-12-30
(186 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TANGSHAN ZHONGHONG PULIN GROUP CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable Device,intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and cxaminer.
Device Description
Class I vinyl patient examination gloves 80LYZ,powder-free,that meets all the requirements of ASTM D 5250-00.
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K Number
K022336Device Name
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD
Manufacturer
TANGSHAN ZHONGHONG PULIN GROUP CO., LTD.
Date Cleared
2002-10-11
(85 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TANGSHAN ZHONGHONG PULIN GROUP CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Vinyl patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Class I vinyl patient examination gloves 80LYZ,powdered,that meets all the requirements of ASTM D 5250-00.
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