← Product Code [MGQ](/productcode/MGQ) · K962513

# DERMAPLEX HYDROGEL WOUND DRESSING (K962513)

_Maxxim Medical · MGQ · Sep 12, 1996 · SU · SN_

**Canonical URL:** https://fda-staging.innolitics.com/device/K962513

## Device Facts

- **Applicant:** Maxxim Medical
- **Product Code:** [MGQ](/productcode/MGQ.md)
- **Decision Date:** Sep 12, 1996
- **Decision:** SN
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Indications for Use

For the local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds.

## Device Story

Dermaplex Hydrogel Wound Dressing; solid hydrogel dressing with polyester liner; supplied sterile in sealed aluminum/plastic laminate pouches; available in 3"x3", 5"x5", and 6"x10" sizes. Applied by clinician to wound site for local management of ulcers and burns. Provides moist wound environment. Biocompatibility established via rabbit dermal irritation, guinea pig sensitization, and USP Cytotoxicity (Agarose Diffusion) testing.

## Clinical Evidence

Bench testing only. Biocompatibility established via primary dermal irritation (rabbits), sensitization (guinea pigs), and USP Cytotoxicity (Agarose Diffusion) testing.

## Technological Characteristics

Solid hydrogel dressing; polyester liner; supplied in aluminum/plastic laminate pouches; sterile. Biocompatibility per USP Cytotoxicity (Agarose Diffusion), rabbit dermal irritation, and guinea pig sensitization tests.

## Predicate Devices

- Curagel Hydrogel Wound Dressing ([K950412](/device/K950412.md))

## Submission Summary (Full Text)

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# 510 (k) SUMMARY

## I. ADMINISTRATIVE

Submitter: Maxxim Medical, Inc.
104 Industrial Boulevard
Sugar Land, Texas 77478
713-240-2442

Contact Person: Ernest J. Henley

Date of Preparation: July 8, 1996

## II. DEVICE NAME

Proprietary Name: Dermaplex Hydrogel Wound Dressing

Common Name: Wound Dressing

Classification Name: Hydrogel wound and burn dressing

## III. PREDICATE DEVICE

Curagel Hydrogel Wound Dressing; Kendall Healthcare Products Co.; K950412

## IV. DEVICE DESCRIPTION

The Dermaplex Hydrogel Wound Dressing is a solid hydrogel dressing covered with a polyester liner which is removed prior to application. The product is available in three sizes (3" × 3", 5" × 5", and 6" × 10") and is supplied sterile in sealed aluminum/plastic laminate pouches.

Biocompatibility of the device has been established by a primary dermal irritation test in rabbits and a sensitization test in guinea pigs. The product meets the requirements of the USP Cytotoxicity Test (Agarose Diffusion).

## V. INTENDED USE

For the local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds.

Premarket Notification: K962513

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# 510 (k) SUMMARY

## VI. COMPARISON TO PREDICATE DEVICE

The Dermaplex Hydrogel Wound Dressing is similar in composition, function and intended use to the Curagel Hydrogel Wound Dressing (Kendall Healthcare Products Co.) and other legally marketed wound dressing products consisting of solid hydrogel.

Accordingly, Maxxim Medical, Inc. concluded that the Dermaplex Hydrogel Wound Dressing is as safe and effective for its intended use and performs at least as well as legally marketed predicate devices, such as the Curagel Hydrogel Wound Dressing.

Premarket Notification K962513

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**Source:** [https://fda-staging.innolitics.com/device/K962513](https://fda-staging.innolitics.com/device/K962513)

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