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510(k) Data Aggregation
K Number
K120968Device Name
POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
Manufacturer
TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD
Date Cleared
2012-09-19
(173 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TANGSHAN ZHONGHONG PULIN PLASTIC 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 5250-06.
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K Number
K120970Device Name
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE)
Manufacturer
TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD
Date Cleared
2012-07-19
(111 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) 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 Nitrile Patient Examination Gloves , Blue Color that meets all of the requirements of ASTM standard D 6139-10
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