PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)

The PureWay Sharps Container is a single-use, disposable, non-sterile container made of high-density polyethylene (HDPE) plastic, available in 1-gallon, 2-gallon, and 3-gallon sizes. It is designed for safe disposal of hazardous medical sharps such as hypodermic needles, syringes, lancets, and blood needles in healthcare settings by trained professionals.

The device features a conical red base with a clamshell hinge lid that snaps closed, a rectangular 4.07" x 7.47" aperture at the top for vertical or horizontal sharps drop, a fill line to prevent overfilling, and labeled capacity matching its gallon size. It differs from the predicate (K151249) in material (HDPE vs. polypropylene), aperture shape (rectangular vs. 2.75" circular), and lid type (hinge vs. screw top), while maintaining similar overall dimensions, single-use design, and non-sterile status.

ISO 23907-1:2019 for Single Use Sharps Container, covering container stability, strength of handles, resistance to penetration, resistance to damage and leakage after dropping, resistance to spillage by toppling, and fill line indicator. The FDA Guidance Document 'Guidance on the content of Format of Premarket Notification (510(k)) submission for Sharps' (October 1993) was also referenced.