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510(k) Data Aggregation
K Number
K980179Device Name
SHARPS PLUS 5 GALLON SHARPS CONTAINER
Manufacturer
Date Cleared
1998-04-13
(83 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
ROTONICS MFG., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sharps Plus 5 Gallon Reusable Container is used within healthcare settings for the collection of contaminated disposable sharps.
Sharps Plus 5 Gallon Reusable Containers are generally supplied to hospitals by medical waste transporters or medical treatment facilities.
Sharps Plus 5 Gallon Reusable Containers are used by healthcare providers at the point of disposal where potentially infectious sharps waste is generated.
Device Description
The Sharps Plus 5 Gallon Reusable Container is substantially equivalent to the BioSystem The Sharps I result sharps container. The Sharps Plus 5 Gallon Reusable Container meets and exceed the primary design characteristics needed to comply with the OSHA Bloodborne Pathogens Standard as well as the American Society for Testing & Maserials. Data for the following tests have been provided; Free Fall Drop (ASTM DS276-944), Stacking (49 CFR 173.465(d), Penetration (49 CFR 173.465(e), Vibration (49 CFR 173.608, Puncture (Health Devices 22). In each of these tests, the Sharps Plus container passed the test criteria.
The Sharps Plus 5 Gallon Reusable Container has a wall thickness of . 125", approximately twice the thickness of most single use primary sharps containers ( 07" to .05"). The testing data illustrates the highly resilies of linear low-density polyethylene. The container is molded rotationally by building up layers of plastic. Each container is equipped with a needleunwinder. Containers remain locked within the Wall Safe when in use within the healthcare facility. Keys are kept with housekeeping and unit nursing station.
The Sharps Plus 5 Gallon Rousable Container is marketed to medical waste transporters and regional treatment facilities, handling the destruction of infectious waste. The Sharps Plus 5 Gallon Reusable Contamer is used solely as a primary container when being shipped over the road. It is common for these facilities to have a unique waste dumping/loading configuration. The Sharps Plus 5 Gallon Reusable Contamer is designed to be opened, emptied and cleaned mechanically, as per the OSHA Bloodborne Pathogens Standard. As with the prodicate device the lid is designed to slide on and off the container via a tongue and groove track. A mechanical arm is used to slide the lid off of the container. Regional treatment facilities handling reusable medical waste are required to use automated container washers. Containers are washed to remove gross contamination and disinfected with a low-level disinfectant. A "Reuse Tracking Label" is used to track the number of cycles and the length of time, containers are used in the field. The Tracking Label is marked after each wash out cycle. After 12 months of use the containers are discarded.
The use of a "horizontal drop" lid opening reduces exposure to needles improperly discarded. Needles are less likely to be onented with the needle face up towards the opening. Other products on the market, such as Devon Industries, Sage Products and Becon Dickinson, all feature a horizontal drop lid opening. The containers are manufactured with natural linear lowdensity polyethylene and are semi-translucent. This makes viewing the waste level through the cabinet window easier.
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