Written and maintained by CASRAI Editorial Board
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General product and regulatory information for laboratory, clinic and supply staff. It is not medical advice and does not describe how to use a drape in surgery.
Short answer
Ioban is a 3M brand name for antimicrobial incise drapes: sterile, single-use adhesive films applied to the skin at the surgical site. In the United States, FDA groups drapes of this kind under product code KKX, “Drape, Surgical, Antimicrobial” (class II, 21 CFR 878.4370). A Cochrane review of seven randomised trials found no evidence that plastic adhesive drapes reduce surgical site infection; iodine-impregnated drapes showed no effect, and plain drapes were associated with more infections.
Definition and scope
An incise drape is an adhesive film that sticks to the patient’s skin so the surgeon cuts through it. “Ioban” names one manufacturer’s line of these products, so it is a brand, not a generic term. The owner of the brand is 3M: the NLM AccessGUDID record for the Ioban 2 drape (catalogue number 6651EZ) lists the company as 3M Company and the description as “3M Ioban 2 Antimicrobial Incise Drape”.
The same record states that the device is single-use, is a combination product, and is labelled as not made with natural rubber latex. This page covers what the product category is and what independent evidence says about it. For the wider family of sterile surgical drapes, see what a sterile drape is; for a procedure pack that includes drapes, see the C-section kit guide.
How the products are described in regulatory records
FDA’s classification database lists product code KKX as “Drape, Surgical, Antimicrobial”, device class 2, regulation number 878.4370, and notes that such drapes are subject to 510(k) review. The Ioban 2 record in AccessGUDID carries the same KKX code, so a buyer reading the label and the FDA database is looking at the same regulatory category.
FDA’s 510(k) database shows how long the brand family has been in that category and that it is not one chemistry:
- K801550, “3M Germicidal Surgical Incise Drape”, applicant 3M Company, decision date 17 September 1981, substantially equivalent, product code KKX.
- K140250, “3M Steri-Drape CHG Antimicrobial Incise Drape”, applicant 3M Healthcare, decision date 25 July 2014, product code KKX.
- K222578, “3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)”, applicant 3M Company, decision date 18 May 2023.
Ioban, Steri-Drape and adhesive surgical drape: what the names mean
| Name | What it is | Source |
|---|---|---|
| Incise drape / adhesive surgical drape | Generic description of an adhesive film applied to the skin at the incision site | Cochrane review, CD006353 |
| Ioban, Ioban 2 | 3M brand names for antimicrobial incise drapes; one FDA record names a chlorhexidine variant (Ioban CHG) | AccessGUDID; FDA 510(k) K222578 |
| Steri-Drape | 3M brand name that appears in FDA records, for example “Steri-Drape CHG Antimicrobial Incise Drape” | FDA 510(k) K140250 |
| KKX | FDA product code and category, not a brand | FDA classification database |
So “Ioban drape”, “Steri-Drape” and “adhesive surgical drape” are not interchangeable searches for one product: two are brand names that FDA records attach to antimicrobial drapes, and one is the generic description of the whole film-drape category.
What the independent evidence says
Webster and Alghamdi’s Cochrane review, “Use of plastic adhesive drapes during surgery for preventing surgical site infection” (CD006353, published 22 April 2015, fourth update), compared adhesive drapes with no adhesive drapes in randomised trials. It included seven trials. Its results, as shown in the PubMed record (checked 31 October 2026):
| Comparison | Studies / participants | Result on surgical site infection |
|---|---|---|
| Plain plastic adhesive drape vs no adhesive drape | 5 / 3,082 | Higher with drapes: risk ratio 1.23 (95% CI 1.02 to 1.48), P = 0.03 |
| Iodine-impregnated adhesive drape vs no adhesive drape | 2 / 1,113 | No effect: risk ratio 1.03, P = 0.89 |
Length of hospital stay was similar between groups. The authors conclude there was no evidence from the seven trials that plastic adhesive drapes reduce surgical site infection rates and some evidence that they increase them, and that further blinded trials by wound classification could be justified. The review’s trials assessed drapes in general and iodine-impregnated drapes; the review summary does not test any one brand, so it should not be read as a result for or against Ioban specifically.
Where it matters for labs, clinics and supply decisions
- Read the regulatory category, not the brand. Antimicrobial drapes sit under product code KKX and 21 CFR 878.4370, class II, so a purchasing record or product file can be matched to FDA’s database by that code.
- The antimicrobial agent is a label detail. FDA records show both a germicidal drape (1981) and a chlorhexidine-containing Ioban variant (2023), so the brand name alone does not tell you the agent.
- Single-use and latex status are in the record. The Ioban 2 AccessGUDID entry lists single-use and “not made with natural rubber latex”.
- Efficacy claims need their own evidence. The Cochrane result above is the independent trial evidence for the category; manufacturer claims are a separate source.
Common misunderstandings
- “Antimicrobial drape” does not mean proven to prevent infection. The Cochrane review found no effect for iodine-impregnated drapes versus none.
- “Steri-Drape” is not a generic word. It appears in FDA records as a 3M product name.
- Ioban is not one formulation. The FDA records above include at least two different antimicrobial agents under the family name.
FAQ
Is Ioban the same as Steri-Drape?
No. Both are 3M brand names that appear in FDA’s 510(k) records for antimicrobial incise drapes (K222578 for Ioban CHG, K140250 for Steri-Drape CHG). They are separate product names in the same FDA category.
What does the Cochrane review say about iodine-impregnated drapes?
Across two studies and 1,113 participants, iodine-impregnated adhesive drapes had no effect on surgical site infection compared with no adhesive drape (risk ratio 1.03, P = 0.89).
How does FDA classify antimicrobial surgical drapes?
As product code KKX, “Drape, Surgical, Antimicrobial”, class II, regulation number 878.4370, subject to 510(k) review.
Is an adhesive surgical drape the same as an incise drape?
In the Cochrane review’s terms, an adhesive drape is a plastic film stuck to the skin; incise drape is the usual product name for the same kind of film. The sterile drape guide covers the wider drape family.
Related CASRAI pages
For the antiseptic background, see what an iodophor is, what an antiseptic is and what a medical device is.
Sources
- Webster J, Alghamdi A. Use of plastic adhesive drapes during surgery for preventing surgical site infection. Cochrane Database of Systematic Reviews 2015, Issue 4, CD006353 (doi 10.1002/14651858.CD006353.pub4), via PubMed, https://pubmed.ncbi.nlm.nih.gov/25901509/, checked 31 October 2026.
- FDA, openFDA device classification, product code KKX, and 510(k) records K801550, K140250 and K222578, https://open.fda.gov/apis/device/, data last updated 19 October 2026, checked 31 October 2026.
- NLM AccessGUDID, 3M Ioban 2 Antimicrobial Incise Drape 6651EZ (DI 30707387507382), https://accessgudid.nlm.nih.gov/devices/30707387507382, checked 31 October 2026.
