← Product Code [MGQ](/productcode/MGQ) · K961085

# DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING (K961085)

_Debusk Knitting Mills, Div. Deroyal Industries · MGQ · May 21, 1996 · SU · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K961085

## Device Facts

- **Applicant:** Debusk Knitting Mills, Div. Deroyal Industries
- **Product Code:** [MGQ](/productcode/MGQ.md)
- **Decision Date:** May 21, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Indications for Use

The DeRoyal Industries, Inc. Multidex® Plus Gel is indicated for use for chronic, non-healing wounds, ulcers, and over burns to provide a protective film and a moist wound environment conducive to healing.

## Device Story

Multidex® Plus Gel is a topical wound dressing; formulation of Multidex® Plus Powder with glycerin. Applied by clinicians or patients to chronic wounds, ulcers, and burns. Functions as a protective film; maintains moist wound environment; controls odor; reduces purulent exudate. Glycerin additive improves solubility, elasticity, and flexibility compared to powder form; facilitates application to difficult-to-reach areas. Non-toxic, non-antigenic, non-allergic; biocompatible with human tissue.

## Clinical Evidence

No clinical data provided. Equivalence based on material composition, intended use, and established safety profile of glycerin.

## Technological Characteristics

Hydrophilic gel dressing; contains Multidex® Plus Powder and glycerin. Glycerin acts as solvent, humectant, plasticizer, and emollient. Non-toxic, non-antigenic, non-allergic. Physical form: gel for improved application compared to powder.

## Predicate Devices

- Multidex® Gel
- Lange, Multidex® Plus Powder

## Reference Devices

- Southwest Technologies, Elasto-gel

## Submission Summary (Full Text)

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05/02/1996 17:08 9386662
SARAH COUGHLIN
PAGE 03
K961085

DeRoyal Industries, Inc.
DEROYAL INDUSTRIES, INC., MULTIDEX® PLUS GEL
510(k) Summary
MAY 21 1996

SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION
UPON WHICH
AN EQUIVALENCE DETERMINATION COULD BE BASED

SUBMITTER INFORMATION
NAME: DeRoyal Industries, Inc.
ADDRESS: 200 DeBusk Lane
ADDRESS: Powell, TN 37849
TELEPHONE: (423) 938-7828
CONTACT: Debra F. Manning
DATE OF PREPARATION: May 2, 1996

DEVICE NAMES
NAME: DeRoyal Industries, Inc., Multidex® Plus Gel
COMMON/USUAL NAME: Multidex® Plus Gel
CLASSIFICATION NAME (if known): Unclassified

PREDICATE OR LEGALLY MARKETED DEVICES
DeRoyal Industries, Inc., Multidex® Gel
Lange, Multidex® Plus Powder

DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Multidex® Plus Gel is the same as Multidex® Plus Powder formulated into a gel; therefore, it functions in the same manner as Multidex® Plus Powder. Like the powder, it is used in cases of chronic, non-healing wounds, ulcers, and over burns as a protective film. Like predicate devices, the gel is used to cover and protect wounds and to provide a moist environment conducive to healing. The basic scientific concepts that form the basis for the device is also like others in that the gel protects against wound dehydration and controls wound odors while decreasing the amount of purulent exudate.

Device Design/Materials Used/Physical Properties: The proposed DeRoyal Industries, Inc. Multidex® Plus Gel includes the same materials as Multidex® Plus Powder. The concept of use is that it can be easily applied to a wound or burn difficult to cover with the powder.

DEVICE INTENDED USE
The DeRoyal Industries, Inc. Multidex® Plus Gel is indicated for use for chronic, non-healing wounds, ulcers, and over burns to provide a protective film and a moist wound environment conducive to healing.

TECHNOLOGICAL COMPARISON WITH MULTIDEX® PLUS POWDER
|  Characteristics | Multidex® Plus Powder | Multidex® Plus Gel | Rationale  |
| --- | --- | --- | --- |
|  Form | Powder | Gel | The gel allows easier application to difficult to reach areas. Also, see explanation below.  |

The combination of glycerin with Multidex® Plus Powder allows a more soluble, elastic, plastic and flexible dressing that mixes better with wound and ulcer fluids.

Glycerin has been known since 600 AD, but was not chemically defined until 1741 by Scheele. It is a non-toxic, non-antigenic, non-allergic substance that is not rejected by human tissues and does not produce inflammatory responses or scarring reactions.

The Merck Manual (11th ed., 1988) lists the properties of glycerin including its use as a solvent, humectant, plasticizer, and emollient. Glycerin is also used in the fermentation of nutrients, in production of antibiotics, and in the chemical and pharmaceutical industries. It is also found in all human tissues either in pure form or in combination with other substances.

Additionally, as previously indicated, glycerin is used by other manufacturers of gel devices, including Southwest Technologies, in their Elasto-gel.

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**Source:** [https://fda-staging.innolitics.com/device/K961085](https://fda-staging.innolitics.com/device/K961085)

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