What Is a Drain Sponge? Pre-Slit Gauze and FDA Class I

Short answer: a drain sponge is a pre-slit gauze pad, typically sold sterile, that is cut part-way through so it can sit around a tube or drain site without the pad being cut by hand. In the FDA’s product classification it falls under the same code as plain gauze: NAB, a Class I device under 21 CFR 878.4014.

This page describes products and general use; it is not medical advice.

Who this is for: clinic staff, buyers and students who need to read a drain sponge specification line and place the product correctly among other gauze products.

What a drain sponge is

A drain sponge is a gauze-type pad with a slit from one edge to the centre. The slit lets the pad fit around a tube or drain where it leaves the body. Manufacturer records describe the product in exactly these terms: one US federal device-listing record reads “Drain Sponges, 4 x 4 in (10.2 x 10.2 cm), 6-Ply, Nonwoven Rayon and Polyester Blend, Pre-slit”.

Sellers use several names for similar pre-slit pads, including split gauze, G-tube pad, feeding tube pad, PEG tube dressing and trach pad. These are trade terms. This page does not treat them as separate regulatory categories, and it does not claim that every product sold under those names is classified the same way.

How it is built

The listing record above shows the elements that make up a drain sponge specification:

• Pad size: 4 x 4 in (10.2 x 10.2 cm) in that record.
• Ply: 6-ply, meaning six layers of material.
• Material: nonwoven rayon and polyester blend. A second record, for a Hartmann SORBALUX drain sponge, uses the nomenclature term “Non-woven gauze pad” (GMDN term 48131).
• Pre-slit: the cut that lets the pad sit around a tube.
• Sterile: both records describe the product as sterile.

For the plain, uncut material this builds on, see what gauze is.

FDA classification: product code NAB, Class I

The FDA’s product classification database lists the code NAB as “Gauze/Sponge, Nonresorbable, for External Use”, Class I, regulation number 21 CFR 878.4014, under the General and Plastic Surgery panel. The entry shows the submission type as 510(k) exempt, and it is not implanted or life-sustaining (FDA product classification database, checked 2026-10-31).

21 CFR 878.4014 identifies the device as a sterile or nonsterile item for medical use, such as covering a wound to absorb exudate, made as a strip, piece or pad of open woven or nonwoven cotton cellulose or a simple cellulose derivative. Products with added drugs or biologics, or with animal-derived materials, are outside that regulation (eCFR, checked 2026-10-31).

In practice this means a Class I device is generally exempt from premarket notification, though the manufacturer must still register its establishment (FDA product classification database). See the dictionary entry on an FDA-registered establishment. Both drain sponge listing records cited on this page carry product code NAB.

Reading a drain sponge specification line

Term in the record	What the record shows	Source
Size	4 x 4 in (10.2 x 10.2 cm)	AccessGUDID, Cardinal Health record
Ply	6-ply	AccessGUDID, Cardinal Health record; Hartmann record name “DRAIN SPONGE ST 4X4 6PLY”
Material	Nonwoven rayon and polyester blend	AccessGUDID, Cardinal Health record
Construction	Pre-slit	AccessGUDID, Cardinal Health record
Sterility	Packaged sterile (both records)	AccessGUDID, Cardinal Health and Hartmann records
Use	Single-use, non-prescription (Hartmann record)	AccessGUDID, Hartmann record
Latex	Hartmann record: labeled “not made with natural rubber latex”. Check the label of any other product for its own latex statement.	AccessGUDID records
Product code	NAB	Both records; FDA classification database

The Cardinal Health record shows commercial distribution ended on 2022-12-31. It is cited here as an example of how a specification is written, not as a product to buy. In the Hartmann record, size and ply appear only in the product name, not as separate data fields.

Drain sponge, plain gauze and tracheostomy dressing

Product	Key difference
Drain sponge	Pre-slit, so the pad fits around a tube without being cut by hand (listing record: “Pre-slit”).
Plain gauze pad	Uncut pad of woven or nonwoven material; same regulation, 21 CFR 878.4014. See what is gauze.
Tracheostomy dressing	Covered separately, in the tracheostomy dressing guide. A “trach pad” is one of the trade names for a pre-slit pad.

For the wider family of products that cover and protect wounds, see what a wound dressing is.

Who uses it

Drain sponges are handled by clinical and supply staff who stock or label wound-care and tube-site supplies, and by buyers who need to match a catalogue description to a regulatory record. The regulation describes the underlying gauze for medical use such as covering a wound to absorb exudate.

Safe use and handling basics

• Check the label for the sterile statement; both listing records cited here describe the product as sterile.
• Read the latex statement on the label. The Hartmann record carries a “not made with natural rubber latex” label; check each product’s own labeling.
• Single-use products are not for reuse (Hartmann record: single-use).
• Follow the manufacturer’s instructions for use. This page gives no application steps.

Common mistakes

• Treating the names as official categories. “Split gauze”, “G-tube pad” and “trach pad” are trade terms; the FDA code NAB covers gauze and sponge products generally.
• Assuming a size from the name. In the Hartmann record the size and ply sit in the product name only, so confirm them on the label.
• Assuming latex status. Of the two records cited here, only the Hartmann record carries the “not made with natural rubber latex” label; confirm on each product’s labeling.
• Reading Class I as “unregistered”. Class I products are generally 510(k) exempt, but the manufacturer must still register its establishment.

Frequently asked questions

What is a drain sponge?

A pre-slit gauze pad used around a tube or drain site. A listing record describes one as “4 x 4 in, 6-ply, nonwoven rayon and polyester blend, pre-slit”.

Is a drain sponge the same as split gauze?

Sellers use “split gauze” for similar pre-slit pads, but both are trade terms rather than separate FDA categories.

What do G-tube pads, feeding tube pads, PEG tube dressings and trach pads have in common with it?

Sellers describe them as pre-slit pads for tube sites. Read each product’s own label and listing record for its material, size and sterility.

How is a drain sponge regulated?

Under product code NAB, a Class I device under 21 CFR 878.4014, generally exempt from premarket notification (FDA, checked 2026-10-31).

What does 6-ply mean?

Six layers of material in the pad, as stated in the specification line.

Sources

• FDA, product classification NAB, “Gauze/Sponge, Nonresorbable, for External Use”: accessdata.fda.gov (checked 2026-10-31).
• 21 CFR 878.4014, Nonresorbable gauze/sponge for external use: ecfr.gov (checked 2026-10-31).
• AccessGUDID, Cardinal Health drain sponge record: accessgudid.nlm.nih.gov (checked 2026-10-31).
• AccessGUDID, Hartmann SORBALUX drain sponge record: accessgudid.nlm.nih.gov (checked 2026-10-31).