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510(k) Data Aggregation
K Number
K101943Device Name
SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
2010-11-08
(119 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TANGSHAN JITENG PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove, blue color, is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D6319-05.
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K Number
K100074Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
Manufacturer
Date Cleared
2010-02-26
(46 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TANGSHAN JITENG PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.
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K Number
K100075Device Name
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
Manufacturer
Date Cleared
2010-02-26
(46 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TANGSHAN JITENG PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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, Colored (White)
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K Number
K090537Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Manufacturer
Date Cleared
2009-03-19
(20 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TANGSHAN JITENG PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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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