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510(k) Data Aggregation
K Number
K101567Device Name
SHARPS CONTAINER
Manufacturer
Date Cleared
2010-09-02
(90 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
CIXI LEINUO PLASTIC CO. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The sharps container are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian office and other small quantity waste generators for the safe disposal of hazardous sharps.
Device Description
The Sharps Container is a piece of equipment used in hospitals, physicians' offices, dental offices, laboratories, home health areas, patient rooms and other locations of medical waste. The sharps container is designed to safely contain used needles or syringes and prevent accidental needle sticks from used syringes or needles.
The device is made of injected molded polypropylene material. The material . is made of molded plastic into a specific shape. The actual shape is designed to sit on the floor or a desk.
On the outer casing of all the sharps containers is the Biohazard Warning label in Orange, noticeably displayed.
The molded plastic container is designed and manufactured such that there . will be no leakage during storage, handling or transport.
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