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General product information only, not medical advice. Questions about a specific person’s skin or appliance belong with their ostomy nurse or clinician.
Short answer
Stomahesive is a ConvaTec brand family of ostomy skin-barrier products, not a single item: wafers, strips, paste and powder. The U.S. FDA’s device database lists the line’s original 510(k) clearances (1979 to 1985, first E. R. Squibb and Sons, then ConvaTec) and classifies this device type as Class 1 under 21 CFR 876.5900.
Definition and scope
An ostomy skin barrier is the part of an ostomy appliance that sits between the skin and the pouch. The Stomahesive name has been applied to several forms of barrier product rather than one. This page maps what the name covers and how the products are classified; it does not give care instructions. For the pouch itself, see what is an ostomy bag, and for the barrier category, solid skin barriers.
How the paste is used in practice (manufacturer’s description)
ConvaTec’s application card for Stomahesive Paste (document AP-007806-US, June 2009) describes the paste as designed for use together with Stomahesive and Durahesive skin barriers or wafers. It states that the paste is not a glue or adhesive. It is described as a filler or caulking substance that increases skin-barrier wear time by providing a flat pouching surface and helping to prevent leakage under the barrier. The card covers use with both pre-cut and cut-to-fit barriers. Application steps are in the manufacturer’s current instructions and are not reproduced here; see also how to use stoma paste and Eakin rings, a different type of barrier accessory.
Types: the Stomahesive items in the FDA UDI database
The FDA’s Global Unique Device Identification Database (GUDID), queried through openFDA on 2026-11-08 for brand name Stomahesive, returns six ConvaTec records. All are flagged single use.
| Product (as listed) | Form | Size or quantity listed | GUDID distribution status |
|---|---|---|---|
| Skin Barrier, item 021712 | Wafer | 4 in x 4 in | In commercial distribution |
| Skin Barrier, item 021715 | Wafer | 8 in x 8 in | In commercial distribution |
| Strips (moldable adhesive), item 025542 | Strips | As listed in the record | In commercial distribution |
| Paste, item 183910 | Paste | 2 oz tube | In commercial distribution |
| Protective Powder, item 025510 | Powder | 1 oz | In commercial distribution |
| Wafer, item 021901 | Wafer | 10 cm x 10 cm, pack of 5 | Not in commercial distribution |
The table lists database records, not a current catalogue. Which items a given supplier stocks changes over time.
The FDA regulatory trail
openFDA’s 510(k) records for the name Stomahesive (read 2026-11-08) show four premarket notifications:
| 510(k) | Device name | Applicant | Product code | Decision date |
|---|---|---|---|---|
| K792382 | Stomahesive Powder | E. R. Squibb and Sons | EXB | 1979-12-20 |
| K800750 | Stomahesive Sterile Wafer | E. R. Squibb and Sons | EXB | 1980-05-08 |
| K803100 | Stomahesive Paste Protective Skin Barrier | E. R. Squibb and Sons | EZR | 1981-01-08 |
| K851840 | Stomahesive Skin Barrier Sterile | ConvaTec (a division of E. R. Squibb and Sons) | EXB | 1985-06-24 |
The classification database defines product code EXB as “Collector, Ostomy” and EZR as “Cement, Stomal Appliance, Ostomy”. Both are Class 1 devices under 21 CFR 876.5900 (ostomy pouch and accessories), reviewed by the Gastroenterology and Urology panel. The paste therefore sits in a different product code from the wafers and powder, which is a useful detail when matching a product to a catalogue category.
Where it matters for clinics and supply teams
- Match the form to the record: wafer, strip, paste and powder are separate items with separate identifiers, so a purchase order or formulary entry that says only “Stomahesive” is ambiguous.
- Check distribution status: at least one wafer record is marked not in commercial distribution in GUDID.
- Paste is a companion to a barrier, per ConvaTec, not a substitute for one.
- For coverage questions on ostomy supplies, see does Medicare cover ostomy supplies.
Common misunderstandings
- “Stomahesive is the paste.” The name covers wafers, strips, paste and powder.
- “The paste is an adhesive.” The manufacturer states it is not a glue or adhesive but a filler.
- “A 510(k) clearance means a current product.” The clearances listed date from 1979 to 1985 and show regulatory history, not current stock.
FAQ
What is Stomahesive?
A ConvaTec brand family of ostomy skin-barrier products: wafers, strips, paste and powder.
Is Stomahesive paste an adhesive?
No. ConvaTec’s application card describes it as a filler or caulking substance used with a skin barrier, and states it is not a glue or adhesive.
How does the FDA classify Stomahesive products?
As Class 1 ostomy devices under 21 CFR 876.5900, with product code EXB (collector, ostomy) for the wafers and powder and EZR (cement, stomal appliance, ostomy) for the paste.
Sources
- openFDA device 510(k) API, search for device name Stomahesive: https://api.fda.gov/device/510k.json (read 2026-11-08)
- openFDA device classification API, product codes EXB and EZR: https://api.fda.gov/device/classification.json (read 2026-11-08)
- openFDA device UDI API (GUDID), brand name Stomahesive: https://api.fda.gov/device/udi.json (read 2026-11-08)
- 21 CFR 876.5900, Ostomy pouch and accessories: https://www.law.cornell.edu/cfr/text/21/876.5900
- ConvaTec, “How to Use Stomahesive Paste”, AP-007806-US, June 2009 (read 2026-11-08)
