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510(k) Data Aggregation
K Number
K092000Device Name
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2009-09-18
(78 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANGDONG ZIBO SHANCHUAN MEDICAL INSTRUMENTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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
Patient Vinyl Examination Gloves, Powderfree, Non-Sterile
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K Number
K021993Device Name
SHANCHUAN SYRINGE
Manufacturer
Date Cleared
2003-06-03
(350 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
SHANGDONG ZIBO SHANCHUAN MEDICAL INSTRUMENTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SHANCHUAN Piston Syringe is design for medical purposes to inject fluids into or withdraw fluids from the body. The syringe has a graduated barrel, a plunger, a hub and a needle.
The SHANCHUAN Insulin Syringe is design for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange.
The syringe fluid path is sterile, non-toxic, non-pyrogen and single use, disposable.
Device Description
The SHANCHUAN Piston Syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a nozzle for fitting the hub of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
The Hypodermic Single Lumen Needle is a device intended to inject below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a hub designed syringe or an intravascular administration set.
The Insulin Syringe is a piston syringe, typically sterile, single-use with a needle, used for subcutaneous injection of insulin.
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