BEMIS TWO GALLON SHARPS CONTAINER

K965248 · Bemis Mfg. Co. · FMI · Feb 14, 1997 · General Hospital

Device Facts

• Record ID: K965248
• Device Name: BEMIS TWO GALLON SHARPS CONTAINER
• Applicant: Bemis Mfg. Co.
• Product Code: FMI · General Hospital
• Decision Date: Feb 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The Bemis Two Gallon Sharps Containers are designed for use in areas with controlled access such as labs and pharmacies. They contain features for both temporary and final closure.

Device Story

Bemis Two Gallon Sharps Container is a single-use, puncture-resistant, leakproof receptacle for medical sharps. Constructed from injection-molded polypropylene; features include temporary and final closure mechanisms, a needle key for unscrewing needles from blood collection holders, and a translucent body for visual fill-level monitoring. Designed for use in controlled-access areas like labs and pharmacies; operated by healthcare personnel. The device is wall-mountable with a locking bracket system. It provides a safe containment method for sharps to prevent accidental injury during disposal and handling.

Clinical Evidence

Bench testing only. The device was evaluated against ECRI criteria for puncture resistance (meeting >3.4 lb./ft. average force), leak resistance (no leakage over 24 hours), and stability (retaining contents when toppled at >20 degrees). Impact resistance was verified by passing a 24-inch drop test per Canadian Standard CAN/CSA-Z316.6.

Technological Characteristics

Material: Polypropylene. Dimensions: 8.5"H x 11.5"W x 7.6"D. Volume: 6 qt. Wall thickness: minimum 0.055". Features: Puncture-resistant, leakproof, translucent body, needle removal key, wall-mount locking bracket. Non-reusable. Complies with ECRI criteria for puncture, leak, and overfill warning; meets Canadian Standard CAN/CSA-Z316.6 for impact resistance.

Indications for Use

Indicated for the disposal of sharps, including butterfly needles, test tubes, and vials, in controlled access environments such as laboratories and pharmacies.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body 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 female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• Baxter Two Gallon Sharps Container

Submission Summary (Full Text)

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FEB 14 1997
510K SUMMARY
K965248

Submitter's Name: Bemis Manufacturing Company
Address: 300 Mill Street
Sheboygan Falls, WI 53085
Telephone: [phone] ext. 2273
Contact Person: John B. Howell
Date Submitted: November 26, 1996
Revised January 17, 1997

Name of Device: Common Name: Sharps Disposal Container
Tradename: Bemis Two Gallon Sharps Container
Classification Name: Sharps Disposal Container

Predicate Device: Baxter Two Gallon Sharps Container

Description of the Device

The Bemis Two Gallon Sharps Containers are designed for use in areas with controlled access such as labs and pharmacies. They contain features for both temporary and final closure.

The Bemis Two Gallon Sharps Containers have a volume of 6 qt. and weigh 1 lb. 2 oz. with dimensions of 8.5"H x 11.5"W x 7.6"D. Two Gallon Sharps Containers are injection molded of polypropylene plastic and are available in translucent red and beige. These containers are NOT reusable.

Bemis Two Gallon Sharps Containers are puncture resistant with integral sidewalls and bottom and have a typical wall thickness of .070". ASTM proposed standard for puncture resistance states "...the average puncture force for the sharps contact areas of each region of nominal uniform thickness of the container shall not be less than 3.4 lb./ft. with no one value less than 2.8 lb./ft." according to ECRI Puncture Resistance criteria. Testing was done on the Bemis Two Gallon Sharps Containers using this standard. All wall thicknesses of .050" will pass the puncture tests, however, Bemis will reject any parts with wall thicknesses less than .055".

The containers are leakproof on the sides and bottom. According to ECRI Health Devices Leak Resistance criteria "...there shall be no leakage of the contents over a 24 hour period when filled with water and positioned in an upright position." The Bemis Two Gallon Sharps Containers passed this requirement when tested using this method.

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The Two Gallon Sharps Containers are labeled with the Biohazard warning symbol that is 1½" in height. The label color is orange-red, with lettering and symbol in contrasting color in accordance with OSHA regulations. The labels are attached directly to the surface of the container by a permanent adhesive. The labels boldly indicate fill level of three-quarter capacity. While no standards exist for overfill detection, ECRI Overfill Warning criteria specifies that contents be viewed to determine fill level. Bemis Two Gallon Sharps Containers are translucent with clear lids, therefore, allowing visibility at all levels.

The Bemis Two Gallon Sharps Container is designed for use in areas with controlled access. According to ECRI Inlet and Closure Characteristics criteria, the inlet should accept sharps safely and easily with one-handed operation. There is no limitation to hand access for this container as the opening is designed to accept other objects such as butterfly needles, test tubes and vials. Following final closure, the container remains closed during normal handling.

ECRI Freestanding Capability criteria specifies that the container should be stable in it's upright position when tipped to 20 degrees, and when in the temporary closed position, contents should not spill out when toppled. Testing done on the Bemis Two Gallon Sharps Container at a topple angle of greater than 20 degrees, showed the container retaining its solid contents.

No standards exist for impact resistance of sharps containers. The proposed Canadian Standard CAN/CSA - Z316.6 on Impact Resistance states that containers, when in the final closure position and dropped from a distance of 24 inches, remain intact (lid remains on container) and sharps do not escape. Bemis Two Gallon Sharps Containers passed this test.

There are no features to bend, break, or shear the needle. The lid also incorporates a "needle key" which can be used to unscrew needles from blood collection tube holders. After blood collection, the needle is inserted into the slotted opening and slid to the left or right until firmly seated. It is then turned counter-clockwise to unscrew the needle from the tube holder.

Two Gallon Sharps Containers lock on wall mounted brackets. A key that is unique to this bracket is used to unlock containers from the bracket. The containers are shipped in two pieces and require assembly by the user. Instructions are included in every case.