Irrigation Tray: What Is in It, FDA Class and Labeling

General product information only, not medical advice. This page describes what an irrigation tray is and how its contents are documented. It does not describe how to perform irrigation, and it does not cover solutions, pressures or volumes for clinical use.

An irrigation tray is a packaged set built around an irrigating syringe, usually a piston syringe, together with a basin or tray, a graduated container and a few accessories. It is sold as a single unit so the pieces for irrigating a wound or body cavity arrive together. The syringe inside it is a regulated device; the tray as a whole is a kit whose contents differ by product. This page shows what one documented tray contains, how the syringe is classified, and what to check on a product record.

What an irrigation tray is

Under 21 CFR 880.6960, an irrigating syringe is a device “intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube,” used to irrigate, withdraw fluid from, or instill fluid into a body cavity or wound. An irrigation tray packages that syringe with the containers and accessories around it. Vendors label the same idea differently: “irrigation tray,” “wound irrigation kit” and “wound irrigation set” are used for similar products, and the contents behind each name vary.

For how irrigation devices, solutions and wound types fit together, see the wound and surgical irrigation supplies guide. For syringes in general, see what is a syringe. A tray assembled by a manufacturer to a customer’s own list is a different product, covered in custom procedure trays.

Checklist table: contents of one documented irrigation tray

The contents list below comes from the FDA’s AccessGUDID record for the AMSure Irrigation Tray with Piston Syringe (AMSINO International, device identifier 10704411008118), checked 4 November 2026. It is one product, not a standard: another tray will list different items.

Category	Item (as listed)	Quantity	Role in the set	Notes
Delivery	60 cc piston irrigation syringe	1 each	The irrigating syringe itself	The regulated device in the set (see below)
Delivery	Tip protector	1 each	Covers the syringe tip	Listed as a separate component
Containers	1000 cc outer tray	1 each	Holds the other components	Volume is the record’s own figure
Containers	500 cc graduated container	1 each	Graduated container for fluid	Smaller than the outer tray
Accessories	Alcohol prep pad	1 each	Included accessory	Listed by the manufacturer
Accessories	Large moisture-proof underpad	1 each	Surface protection	Listed by the manufacturer

The record gives quantities and sizes but not an intended-use statement for each item; the “role” column describes the item’s name, not instructions.

Piston syringe versus bulb syringe trays

The regulation covers both syringe types, so a tray may be built around either. The record above uses a piston syringe. Because either type can be used, the syringe type is one of the first things to read on a spec sheet. A separate guide covers a bulb design used for ears: ear bulb syringe. Dental irrigation syringes are a different product group, see dental irrigation syringe.

What varies by product and setting

A second FDA record, the Biotronix Healthcare Irrigation Tray with Piston Syringe (device identifier 00850005165040, checked 4 November 2026), shows the variation. It carries the same FDA product code (KYZ, “Syringe, Irrigating (Non Dental)”) and states sterile packaging, single use, and a label that the device is not made with natural rubber latex. Its description reads only “Irrigation Tray with Piston Syringe” and does not itemize contents. So two trays with similar names can be documented to very different levels of detail.

Contents beyond this basic set are a property of each product, so read that tray’s specification sheet or device record rather than assuming a towel, drape or solution is included.

Facility type does not change the regulatory status of the syringe; it changes which kit a facility chooses to stock. Supply lists for specific facilities are in guides such as the wound care clinic supply checklist.

Sterility, single-use and latex labeling

Both FDA records cited on this page state three separate facts that should not be merged: the device is packaged sterile, it does not need sterilization before use, and it is single-use. Both also state that the product is not made with natural rubber latex. These are the manufacturers’ declarations in the FDA database, not independent testing. The difference between sterile and non-sterile supplies is explained in the sterile versus non-sterile purchasing guide.

The regulation ties sterility to oversight. A syringe under 21 CFR 880.6960 that is not labeled or represented as sterile is also exempt from the quality management system requirements of 21 CFR Part 820, except for records and complaint files (21 CFR 820.35). A syringe labeled sterile does not get that exemption. The sterile label therefore changes the manufacturer’s obligations, which is why the record’s sterility field is worth reading.

Storage, expiry and restocking

The AccessGUDID records cited on this page do not state storage conditions, shelf life or restocking quantities, and the regulation does not set them. Those details come from the manufacturer’s label and instructions for use for the specific tray, including any expiration date printed on the package.

Rules that apply

• 21 CFR 880.6960, Irrigating syringe (eCFR, current text checked 4 November 2026): Class I (general controls); exempt from premarket notification (510(k)) under Part 807 subpart E, subject to the limitations in 21 CFR 880.9; quality management system exemption if not labeled sterile, as above.
• FDA product code KYZ, “Syringe, Irrigating (Non Dental)”: the classification both records use.
• Device identifiers: each tray has a unique device identifier in AccessGUDID, which is the quickest way to read what the manufacturer declared.

What to check on a product record

1. Syringe type (piston or bulb) and size, as stated by the manufacturer.
2. Whether the contents are itemized, and the volume of the tray and graduated container.
3. Sterile or non-sterile packaging, and whether the product is single-use.
4. The natural rubber latex statement.
5. Whether the contents list includes any solution; neither FDA record cited on this page lists one.

FAQ

What is in an irrigation tray?

It depends on the product. One documented example (AMSure, AccessGUDID) lists a 1000 cc outer tray, a 500 cc graduated container, a 60 cc piston irrigation syringe, a tip protector, an alcohol prep pad and a large moisture-proof underpad, one of each.

What is the difference between wound irrigation supplies and a wound irrigation kit?

“Supplies” is the general term for the items used (syringes, containers, solutions, protective layers); a “kit” or tray is those items packaged as one unit. See the irrigation supplies guide for the individual items.

Is an irrigation tray an FDA-regulated device?

The irrigating syringe in it is: Class I under 21 CFR 880.6960 and exempt from premarket notification. The tray as a kit is documented through the manufacturer’s own record.

Are irrigation trays sterile and single-use?

Both FDA records cited on this page state both. Another product may not; check that tray’s record and label.

Does an irrigation tray include saline?

Neither FDA record cited on this page lists a solution among the contents. For the fluid itself, see what is 0.9% sodium chloride.

Sources

• eCFR, 21 CFR 880.6960 Irrigating syringe, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-880/subpart-G/section-880.6960 (checked 4 November 2026).
• FDA/NLM AccessGUDID, AMSure Irrigation Tray with Piston Syringe, AMSINO International, DI 10704411008118, https://accessgudid.nlm.nih.gov/devices/10704411008118 (checked 4 November 2026).
• FDA/NLM AccessGUDID, Biotronix Healthcare Irrigation Tray with Piston Syringe, DI 00850005165040, https://accessgudid.nlm.nih.gov/devices/00850005165040 (checked 4 November 2026).