Tonsil Sponge: What It Is, Sizes and FDA Class

A tonsil sponge is a small, sterile, single-use surgical sponge, on a string, that surgical teams hold at the end of a forceps to absorb fluid and apply pressure during tonsil, adenoid and some nasal procedures. In U.S. product-code listings it is filed under internal gauze or sponge codes rather than a category of its own. It is used by operating-room staff, surgical technologists and sterile-processing and supply buyers; this page helps you identify one, read its label, and tell it apart from similar sponges.

What a tonsil sponge is

The manufacturer Teleflex describes its tonsil sponges as used “at the end of a forceps for absorption and pressure hemostatic control” during tonsil and adenoid surgery, and also in some nasal procedures (for example postnasal or sphenoid packing, medication application and drainage control) (Teleflex product page, checked 2026-11-01).

Device databases file the product under the broader heading of dissection sponges. The GMDN definition (term 13698, “Dissection sponge,” as reproduced in the FDA’s AccessGUDID records) describes a sterile single-use device for blunt tissue dissection made of a small sponge of absorbent material, often with an X-ray radiopaque element, available in shapes such as rosebud, peanut, cherry, round and Kittner (AccessGUDID, checked 2026-11-01).

How it is built

• Fill and cover. Teleflex lists gauze-filled sponges and cotton-filled sponges with a gauze cover.
• String. Teleflex lists double stringing “for secure retrieval after use.”
• X-ray detectable element. Teleflex lists its items as X-ray detectable, packed in groups of five on an accountability card. An ORLocate RFID tonsil sponge record in AccessGUDID also lists the sponge as double strung and X-ray detectable.
• Packaging. Most Teleflex items are sold sterile; at least one cotton item is listed non-sterile, so the label on the specific product governs.

Types, sizes and label data

Sizes are named by each manufacturer and are not a universal standard. The table lists only what the cited records state.

Product record	Size as labeled	Other labeled attributes	Source (checked 2026-11-01)
American Surgical Company “Tonsil Sponges,” model 50-00	3/4 inch, “Medium”; 40 per pack	Single-use; product code EFQ; premarket submission K872806	AccessGUDID device 20749915000746
American Surgical Company “Tonsil Sponges,” model 50-02	1.25 inch, “X-Large”; 40 per pack	Single-use; product code EFQ	AccessGUDID device 20749915000760
ORLocate RFID Tonsil Sponge	Outer diameter 1.25 inch	Double strung; X-ray detectable; sterile package; no sterilization before use; single-use; labeled not made with natural rubber latex; codes GDY and NAB	AccessGUDID device 10724995221024
Teleflex (Pilling) Tonsil Sponges	Medium, Large, X-Large (names only)	Gauze-filled, or cotton-filled with gauze cover; double stringing; X-ray detectable	Teleflex product page

The same size word means different things at different makers: American Surgical’s “Medium” is 3/4 inch, while Teleflex gives size names without dimensions. Read the dimension on the label rather than relying on the name. The American Surgical records carry neither a natural rubber latex warning nor a “not made with natural rubber latex” label.

FDA class and product codes

Under 21 CFR 878.4450, “Nonabsorbable gauze for internal use” is a device made of open mesh fabric, intended for use inside the body or a surgical incision, to control bleeding, absorb fluid or protect organs or structures from abrasion, drying or contamination. It is woven from not less than 50 percent by mass cotton, cellulose or a simple chemical derivative of cellulose, and contains X-ray detectable elements. It is Class I (general controls) and exempt from premarket notification, subject to the limitations in 21 CFR 878.9 (Cornell LII copy of the CFR, checked 2026-11-01).

openFDA lists product code GDY, “Gauze/Sponge, Internal, X-Ray Detectable,” under that regulation as Class 1. Code EFQ, “Gauze/Sponge, Internal,” carries no regulation number in the openFDA record (openFDA device classification, checked 2026-11-01). That is why two tonsil sponge records can show different product codes: the code reflects how the maker listed the item, so the label and the manufacturer’s instructions for use are what describe a specific product.

Safe handling basics

• Labeled single-use: the records above identify these as single-use devices. Do not reprocess or reuse them.
• The ORLocate record describes a sterile package and states no sterilization before use; the manufacturer’s instructions for use govern any specific item.
• Follow the manufacturer’s instructions for use and your facility’s surgical-count policy. The string and X-ray detectable element are described by the maker as aids for retrieval; they do not replace counting, and this page gives no procedure steps. See retained surgical item prevention.

Common mix-ups

• Raytec or laparotomy sponge. A larger flat X-ray detectable gauze pad is a different product; see what a Raytec sponge is.
• Drain sponge. A slit gauze dressing placed around a drain is a different product; see what a drain sponge is.
• Plain gauze. General gauze types are covered in what is gauze.
• Other dissection sponges. Peanut, cherry, rosebud and Kittner sponges belong to the same GMDN family but are not all labeled for tonsil use.
• Instruments. The forceps and curettes used alongside sponges are covered in ENT surgical instruments.

Frequently asked questions

What is a tonsil sponge?

A small sponge on a string used at the end of a forceps for absorption and pressure hemostatic control in tonsil and adenoid surgery, per Teleflex’s product page. Device databases class it among dissection sponges.

Is a tonsil sponge single-use?

The American Surgical and ORLocate records in AccessGUDID both flag the device as single-use.

What FDA class is a tonsil sponge?

Under 21 CFR 878.4450, X-ray detectable internal gauze is Class I (general controls) and exempt from premarket notification, subject to 21 CFR 878.9. The American Surgical record, however, lists product code EFQ with premarket submission K872806, so the listing for the specific product is what applies to it.

Are tonsil sponge sizes standard?

No. Size names are set by each maker; American Surgical lists “Medium” as 3/4 inch, while Teleflex gives names without dimensions.

Sources

Checked 2026-11-01.

• 21 CFR 878.4450, Nonabsorbable gauze for internal use: https://www.law.cornell.edu/cfr/text/21/878.4450
• openFDA device classification (product codes GDY, EFQ): https://api.fda.gov/device/classification.json?search=device_name:”sponge”
• AccessGUDID, American Surgical Company Tonsil Sponges: https://accessgudid.nlm.nih.gov/devices/20749915000746 and https://accessgudid.nlm.nih.gov/devices/20749915000760
• AccessGUDID, ORLocate RFID Tonsil Sponge (GMDN term 13698 text is quoted as reproduced in these records): https://accessgudid.nlm.nih.gov/devices/10724995221024
• Teleflex (Pilling) Tonsil Sponges, a manufacturer product page rather than instructions for use: https://us.myteleflex.com/All-Categories/Surgical-Instruments/General/Tonsil-Sponges/p/su-TonsilSponges