What is an approved sharps container?

An approved sharps container is a rigid, puncture-resistant receptacle the FDA has cleared as a Class II medical device accessory under 21 CFR 880.5570 to collect discarded needles, syringes, and other sharps waste.

Rows come from FDA device records — the K180984 clearance summary and AccessGUDID — except the four DCI entries, which are catalog specifications for dental operatory cabinetry and carry no FDA record here. * K180984 prints two dimension tables and they disagree on the MA1122's height: 181 mm against 6.7 in, which is 170 mm.

Look for FDA clearance, not FDA approval. Under the 510(k) premarket notification process, the FDA clears a device by finding it substantially equivalent to a legally marketed predicate device, such as the Oak Ridge Products container (K161180).

21 CFR 880.5570 is not named for sharps containers — the regulation is titled "Hypodermic single lumen needle." Cleared containers are regulated as Class II accessories under that needle classification.

AccessGUDID indexes cleared containers under product code MMK (container, sharps) or FMI (needle, hypodermic, single lumen). Dynarex's DispoSafety 12-gallon container (model 4633) is indexed under MMK, and its AccessGUDID record gives K180984 as the premarket submission; Becton Dickinson's 5.4-quart collector (model 305551) and Cardinal Health's 2-gallon Monoject models (8990SA and 8967Y) are indexed under FMI. FDA's own health-care-facilities page prints the code as "MKK" in one sentence and "MMK" in another; the classification database and the K180984 clearance letter both give MMK.

Cleared containers must be rigid and leak-resistant, with puncture-resistant walls and bottoms. The lid must fit tight — sharps in, hands out. They need a clear fill line, typically marked at 75% to 80% of total volume — 1.6 liters on the 2.1-liter Maxcon MA1122.

OSHA governs workplace use under 29 CFR 1910.1030, which requires containers for contaminated sharps to be closable, puncture resistant, leakproof on sides and bottom, and either labelled or colour-coded. The label must be fluorescent orange or orange-red, carrying the biohazard symbol and the legend BIOHAZARD; a red container may be substituted for it. State law can be stricter. California Health and Safety Code § 117750 defines a sharps container as one "meeting the standards of, and receiving approval from, the United States Food and Drug Administration as a medical device used for the collection of discarded medical needles or other sharps" — the statute's word is approval, and for a Class II device that status is obtained by 510(k) clearance. The same section prohibits plastic bag liners. California § 118285 limits unapproved storage of full containers to 30 days and allows "sharps waste" labeling as an alternative to the biohazard symbol.

In dental operatories, the container mounts into the cabinetry. The DCI-6802 counter mount holds a 1.7-quart replacement container. These are heavy-duty operatory cabinetry fixtures, not consumer travel products.

Where to buy

We do not link retail listings for these professional-grade clinic and operatory sharps containers.

Sources

• FDA Product Classification Database — Product Code MMK
• FDA Product Classification Database — Product Code FMI
• FDA — Sharps Disposal Containers in Health Care Facilities
• FDA — Sharps Disposal Containers (Consumer Page)
• FDA — 510(k) Clearance Letter and Summary K180984, Maxcon Sharps Container
• OSHA — 29 CFR 1910.1030, Bloodborne Pathogens
• California Legislature — California Health and Safety Code § 117750
• California Legislature — California Health and Safety Code § 118285
• AccessGUDID — Monoject Sharps Container, Red, 2 Gallon (Model 8990SA)
• AccessGUDID — Monoject Sharps Container, Yellow, 2 Gallon (Model 8967Y)
• AccessGUDID — DispoSafety Medical Waste Sharps Container (Model 4633)
• AccessGUDID — BD Sharps Collector (Model 305551)

Specifications last verified: 2026-07-31