(152 days)
Medine Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
Medline 1 Qt:Sharps Container: Dimensions - 95 x 95 x 153mm Color - Red Base, White Translucent Top Empty Weight - 107g
Medline 5 Qt Sharps Container: Dimensions - 265 x 113 x 233mm Color - Red Base, White Translucent Top Empry Weight - 360g
This document is a 510(k) premarket notification letter from the FDA to Medline Industries Incorporated regarding their Sharps Container. It is a regulatory approval document and does not contain information about acceptance criteria or a study proving device performance as typically understood for medical device efficacy or safety studies.
The document confirms that the device, Medline Sharps Container (Trade/Device Name: Medline Sharps Container; Product Code: MMK; Regulation Number: 21 CFR 880.5570), is substantially equivalent to legally marketed predicate devices. This means that the FDA has determined the new device is as safe and effective as a legally marketed predicate device.
The information provided relates to regulatory compliance and the intended use of the device, not detailed performance studies or clinical trial data.
Therefore, I cannot provide a response to your request, as the necessary information (acceptance criteria, device performance results, study details, sample sizes, expert qualifications, etc.) is not present in the provided text.
§ 880.5570 Hypodermic single lumen needle.
(a)
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.(b)
Classification. Class II (performance standards).