← Product Code [MGQ](/productcode/MGQ) · K961067

# BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKET (K961067)

_Medtrak Intl., Inc. · MGQ · May 16, 1996 · SU · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K961067

## Device Facts

- **Applicant:** Medtrak Intl., Inc.
- **Product Code:** [MGQ](/productcode/MGQ.md)
- **Decision Date:** May 16, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic, Pediatric

## Indications for Use

The BURN-AID Hydrogel, Burn Dressing and Burn Blanket are indicated for single use as a pre-medical first aid for first- and second-degree burns and scalds to cool, soothe and moisturize the burn area.

## Device Story

BURN-AID consists of water-based hydrogel containing Melaleuca alternifolia (tea tree oil), stabilizers, emulsifiers, and preservatives; antiseptic properties. Available as gel in single-use packets, foam sheet dressings, or virgin wool blankets saturated with hydrogel. Used for pre-medical first aid; applied directly to skin by patients or first responders. Cools, soothes, and moisturizes burn sites; aids in immediate burn management.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Hydrogel composition: water, Melaleuca alternifolia extract, stabilizers, emulsifiers, preservatives. Formats: single-use gel packets, foam sheet dressings, virgin wool blankets. Non-sterile/single-use application.

## Predicate Devices

- BurnFree Hydrogel, Dressing & Blanket
- Burnshield Hydrogel, Dressing & Blanket

## Submission Summary (Full Text)

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BURN-AID
MedTrak International, Inc
510(k) Premarket Notification
Appendix VI, 510(k) Summary of Safety and Effectiveness Data
Page 1 of 2

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

## I. General Information

K 961067

A. Submitted By: MedTrak International, Inc.
9841 Broken Land Parkway, Suite 107
Columbia, MD 21406
Tel: (410) 381-6488
Fax: (410) 381-6496
MAY 16 1996

Contact Person: Harold Jaynes at address above

B. Device Trade Name: BURN-AID Hydrogel
BURN-AID Hydrogel Burn Dressing
BURN-AID Hydrogel Burn Blanket

Common Name: Burn Dressing, Blanket, & Gel

Classification Name: Burn Dressing, Blanket, & Gel

C. Predicate Device: BurnFree Hydrogel, Dressing & Blanket
Burnshield Hydrogel, Dressing & Blanket

D. Device Description:

BURN-AID Hydrogel is a water-based gel containing extract of *Melaleuca alternifolia* (tea tree oil) and various stabilizers, emulsifiers and preservatives. The tea tree oil acts as an antiseptic. This gel is available in single-use packets for direct application to the skin. The BURN-AID Burn Dressing is composed of a soft foam sheet impregnated with the BURN-AID Hydrogel. The BURN-AID Burn Blanket is composed of pure virgin wool saturated with the BURN-AID Hydrogel.

E. Indications for Use:

The BURN-AID Hydrogel, Burn Dressing and Burn Blanket are indicated for single use as a pre-medical first aid for first- and second-degree burns and scalds to cool, soothe and moisturize the burn area.

F. Device Comparison:

The BURN-AID products are substantially equivalent to various other currently legally marketed burn products, including those marketed under the name BurnFree and Burnshield. Each of these products are available as a

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BURN-AID
MedTrak International, Inc
510(k) Premarket Notification
Appendix VI, 510(k) Summary of Safety and Effectiveness Data
Page 2 of 2

hydrogel containing tea tree oil, as a burn dressing impregnated with the hydrogel, or as a burn blanket impregnated with the hydrogel.

II. Testing: No additional testing necessary

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**Source:** [https://fda-staging.innolitics.com/device/K961067](https://fda-staging.innolitics.com/device/K961067)

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