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What Is DuoDERM? Hydrocolloid Dressing Explained

What DuoDERM hydrocolloid dressings are, with FDA 510(k) clearance dates, listed sizes and the maker’s description of how they work.

Written and maintained by CASRAI Editorial Board

Last updated

DuoDERM is ConvaTec’s brand of hydrocolloid wound dressings and related hydroactive gels. It is a physical product line used by clinic staff, wound care buyers and students who need to know what the name covers, how the product is cleared by the FDA and what sizes exist.

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

What DuoDERM is

DuoDERM is a family of hydrocolloid dressings made by ConvaTec. ConvaTec states that DuoDERM dressings were the first to incorporate hydrocolloid technology, and describes them for light to moderate exudate (wound fluid). Who uses it: clinic and wound care staff, and the buyers who stock them. For the general class, see our guide to hydrocolloid wound care; for the wider category, see what a wound dressing is.

How DuoDERM works

ConvaTec says that on contact with a moist wound surface, DuoDERM dressings form a gel that creates a moist wound healing environment, and that a honeycomb matrix of hydrocolloid particles absorbs exudate into a soft, moist gel. DuoDERM CGF is described by the maker as a hydrocolloid, moisture-retentive wound dressing. The maker states that the CGF product does not contain latex.

DuoDERM product variants and FDA clearances

The FDA’s openFDA 510(k) database lists many DuoDERM clearances from ConvaTec (formerly a division of E.R. Squibb and Sons, later Bristol-Myers Squibb). The table shows several of the main dressing and gel clearances. A 510(k) clearance is not an endorsement of performance for any individual patient.

Product (as named in the FDA record) 510(k) number Decision date
DuoDERM flexible hydroactive dressings K841287 1984-08-20
DuoDERM CGF K881050 1988-04-01
DuoDERM Extra Thin CGF dressing K925990 1993-10-28
DuoDERM CGF Control Gel Formula dressing and border K925991 1993-10-28
DuoDERM Extra Thin CGF dressing K973716 1997-12-17
DuoDERM Hydroactive Gel K973806 1997-12-29

For DuoDERM CGF (K881050) the FDA record carries product code NAD. Under the FDA’s classification database, NAD is “Dressing, Wound, Occlusive”, a Class I device under 21 CFR 878.4020. The FDA’s UDI database (AccessGUDID) held 31 DuoDERM-branded records when checked on 2026-10-30. Those records are single-use and not labelled as containing natural rubber latex. Product lines named in them include DuoDERM CGF, CGF Border, Signal, Extra Thin (XTHIN) and H/ACTIVE GEL.

Sizes listed for DuoDERM

Two sources give sizes: ConvaTec’s ordering table for DuoDERM CGF (US wording), and size values in FDA UDI records.

Line Sizes (cm) Source
DuoDERM CGF, rectangle 15 x 20 (5 per box); 20 x 30 (5 per box) ConvaTec product page
DuoDERM CGF, square 10 x 10 (20 or 5 per box); 15 x 15 (20 or 5 per box); 20 x 20 (5 per box) ConvaTec product page
CGF Border 6 x 6; 10 x 10; 15 x 15; 15 x 18; triangle 10 x 13 FDA UDI records
Extra Thin 5 x 10; 7.5 x 7.5; 10 x 10; 15 x 15; 5 x 20; oval 10 x 15; triangle 15 x 17.5 FDA UDI records
Hydroactive Gel (tube) 15 g; 30 g FDA UDI records

How to apply DuoDERM

Application and removal steps are in the manufacturer’s package insert (instructions for use), which ConvaTec links from the product page. Follow it, and the instruction of the treating clinician, for the specific product in hand; steps differ between product lines, so this page does not reproduce them. The package insert is the authority for how long a given product is intended to stay in place.

Labelled uses

Intended uses are set out in each product’s labelling and package insert, and they can differ between DuoDERM lines and between regional ConvaTec pages. Read the labelling of the exact product.

Safe use and handling basics

  • Use the product within its package insert and the clinician’s plan; do not use a different line as a substitute without checking its labelling.
  • The records are single-use, sterile-labelled products; check the package before use.
  • ConvaTec states that using a DuoDERM dressing neither guarantees nor warrants against transmission of HIV or HBV.

Common mistakes

  • Treating “DuoDERM” as one product: the name covers dressings, borders, extra thin versions and gels with different sizes.
  • Assuming a generic hydrocolloid has identical labelling; compare the package insert for each product.
  • Reading FDA clearance as a clinical recommendation; it is a regulatory decision about the device.
  • Following steps from a general web page instead of the package insert.

FAQ

What is DuoDERM?

DuoDERM is ConvaTec’s brand of hydrocolloid wound dressings and hydroactive gels, which form a gel on contact with a moist wound surface according to the maker.

How do you apply DuoDERM?

Follow the manufacturer’s package insert for the exact product and your clinician’s instructions. Wear time is also stated there.

Is DuoDERM latex-free?

ConvaTec states DuoDERM CGF does not contain latex, and FDA UDI records for DuoDERM products are not labelled as containing natural rubber latex. Check the label of the specific product.

Is DuoDERM cleared by the FDA?

The openFDA 510(k) database lists multiple DuoDERM clearances from ConvaTec, with decision dates from 1982 to 1999 (see table).

Related products

Other dressing classes covered on CASRAI include calcium alginate, honey dressings and barrier film. Facilities that stock these items can browse wound dressings.

Sources

  • ConvaTec, DuoDERM Dressings, https://www.convatec.com/advanced-wound-care/duoderm-dressings/ (checked 2026-10-30)
  • ConvaTec, DuoDERM CGF Sterile Dressing, https://www.convatec.com/products/advanced-wound-care/wound-type/pc-wound-leg-ulcers/duoderm-cgf-sterile-dressing/ (checked 2026-10-30)
  • FDA openFDA 510(k) database, https://api.fda.gov/device/510k.json (queried 2026-10-30)
  • FDA openFDA device classification, product code NAD, https://api.fda.gov/device/classification.json (queried 2026-10-30)
  • FDA openFDA UDI database, https://api.fda.gov/device/udi.json (queried 2026-10-30)

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