← Product Code FRO · K032462

# CURAD SILVER ACTIVE GEL BANDAGE (K032462)

_Beiersdorf AG · FRO · Feb 10, 2004 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K032462

## Device Facts

- **Applicant:** Beiersdorf AG
- **Product Code:** FRO
- **Decision Date:** Feb 10, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Intended Use

The CURAD® Silver Active Gel Bandage is indicated for first aid to help in minor abrasions, cuts, lacerations, scrapes, and scalds.

## Device Story

CURAD® Silver Active Gel Bandage is a polyurethane occlusive wound dressing; incorporates silver oxide within the polyurethane matrix. Device provides moist healing environment; silver ions reduce bacterial growth in wound pad. Intended for first aid use on minor abrasions, cuts, lacerations, scrapes, and scalds. Used in home or clinical settings; applied by patient or caregiver. Output is physical barrier and antimicrobial protection; aids in wound management and infection prevention.

## Clinical Evidence

Bench testing only. Performance testing evaluated silver release and antimicrobial effect, demonstrating acceptable results. Biocompatibility assessment performed on patient-contacting and fluid-path materials with satisfactory results.

## Technological Characteristics

Polyurethane occlusive bandage; silver oxide embedded in polyurethane matrix. Provides moist healing environment and antimicrobial silver ion release. Biocompatible materials.

## Predicate Devices

- Silver Strips™ Adhesive Strips ([K023609](/device/K023609.md))
- Actisorb™ Silver 220 Antibacterial Binding Dressing ([K022483](/device/K022483.md))
- Acticoat™ Composite Wound Dressing ([K002466](/device/K002466.md) & [K983833](/device/K983833.md))
- Aquacel® Ag with Hydrofiber Silver Impregnated Antimicrob Dressing ([K013814](/device/K013814.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}------------------------------------------------

K032462

# 510(k) Summary for CURAD® Silver Active Gel Bandage

#### 1. SPONSOR

Beiersdorf AG Hamburg, Germany

Contact Person: Mr. Volker Holle Date Prepared: May 7, 2004

#### 2. Device Name

CURAD® Silver Active Gel Bandage Proprietary Name: Common/Usual Name: Occlusive wound dressings with added drug Classification Information:

Occlusive wound dressings with added drugs have not yet been classified by the FDA or given a Product Code. Occlusive wound dressings without added drugs have been designated as Class I devices and exempt from 510(k) submission requirements. Other types of wound dressings with added drugs have been given a product code but not classified and several of the predicate products have been classified under the Product Code, "FRO." See below.

|                                                                                            | Product |             |                         |
|--------------------------------------------------------------------------------------------|---------|-------------|-------------------------|
| Names of Related Products                                                                  | Code    | 21 CFR Ref. | Panel                   |
| Occlusive Wound Dressing                                                                   | NAD     | 878.4020    | General/Plastic Surgery |
| Hydrogel Wound and Burn Dressing with a Drug<br>and/or Biologic                            | MGQ     | None        | General/Plastic Surgery |
| Nonabsorbable Gauze, Surgical Sponge, and Wound<br>Dressing for External Use (with a Drug) | MXI     | None        | General/Plastic Surgery |
| Dressing                                                                                   | FRO     | None        | General/Plastic Surgery |

Beiersdorf AG 510(k) No. K032462 CURAD® Silver Active Gel Bandage

Appendix E · Page 1

{1}------------------------------------------------

## PREDICATE DEVICES 3.

CURAD® Silver Active Gel Bandage is substantially equivalent to the following devices:

| Product                                                               | Submitter          | 510(k)            |
|-----------------------------------------------------------------------|--------------------|-------------------|
| Silver Strips™ Adhesive Strips                                        | Argentum Medical   | K023609           |
| Actisorb™ Silver 220 Antibacterial Binding Dressing                   | J & J Medical      | K022483           |
| Acticoat™ Composite Wound Dressing                                    | Westaim Biomedical | K002466 & K983833 |
| Aquacel® Ag with Hydrofiber Silver Impregnated Antimicrob<br>Dressing | ConvaTec           | K013814           |

#### 4. DEVICE DESCRIPTION

The CURAD® Silver Active Gel Bandage is a polyurethane occlusive bandage that includes silver oxide in the polyurethane matrix. The polyurethane provides a moist healing environment. At the same time, silver ions reduce bacterial growth in the wound pad.

#### 5. INTENDED USE

The CURAD® Silver Active Gel Bandage is indicated for first aid to help in minor abrasions, cuts, lacerations, scrapes, and scalds.

## 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

CURAD® Silver Active Gel Bandage has similar materials to other wound dressings with silver and equivalent concentrations of silver are released. A biocompatibility assessment was performed on the patient-contacting and fluid-path materials of CURAD® Silver Active Gel Bandage with satisfactory results.

### 7. PERFORMANCE TESTING

CURAD® Silver Active Gel Bandage was tested for silver release and antimicrobial effect and was demonstrated to have acceptable results.

Beiersdorf AG 510(k) No. K032462 CURAD® Silver Active Gel Bandage May 7, 2004

Appendix E · Page 2

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three human figures, represented by curved lines, overlapping each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2004

Beiersdorf AG c/o Mr. Daniel Dillon Medial Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K032462

Trade/Device Name: CURAD® Silver Gel Bandage Regulatory Class: Unclassified Product Code: FRO Dated: November 14, 2003 Received: November 17, 2003

Dear Mr. Dillon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see ahove) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if anplicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CIFR 1000-1050.

{3}------------------------------------------------

Page 2 - Mr. Daniel Dillon

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark M Millissen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known):

K032462

CURAD® Silver Gel Bandage Device Name:

Indications for Use:

The CURAD® Silver Gel Bandage is indicated for first aid to help in minor abrasions, cuts, lacerations, scrapes, and scalds.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

f. Mark A. Milbern

Rostorative VICES

K032462

---

**Source:** [https://fda.innolitics.com/device/K032462](https://fda.innolitics.com/device/K032462)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com