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510(k) Data Aggregation
K Number
K071072Device Name
SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
Manufacturer
Date Cleared
2007-08-30
(136 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI CHINA STAR CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.
Device Description
Shanghai China Star Corp Powder free blue Nitrile Examination Glove is a class I device having product code 80LZA. It is a disposable device powdered with absorbable dusting powder that meets all requirements of ASTM D 631900a-05 and is tested with chemotherapy drugs.
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