BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING

K990180 · Nortrade Medical, Inc. · MGQ · Aug 13, 1999 · SU

Device Facts

• Record ID: K990180
• Device Name: BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING
• Applicant: Nortrade Medical, Inc.
• Product Code: MGQ · SU
• Decision Date: Aug 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

1. First aid for burns, scalds, cuts, and abrasions. 2. Relieves Pain. 3. Cools and Soothes. 4. Moistens. 5. Non-Adherent 6. Bacteriostatic

Device Story

Burnfree Sterile Wound and Burn Dressing is a sterile, non-adherent dressing used for first aid of burns, scalds, cuts, and abrasions. The dressing provides a moist environment to cool and soothe the affected area while offering bacteriostatic properties. It is intended for over-the-counter use. The dressing must remain sealed until use; it is applied directly to the wound site to provide protection and pain relief. The packaging may serve as an outer cover. Patients are advised to seek medical attention after initial application.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile, non-adherent wound dressing. Bacteriostatic properties. Form factor includes various sizes (4"x 4", 8"x 8", 16"x 24").

Indications for Use

Indicated for first aid treatment of burns, scalds, cuts, and abrasions in patients requiring pain relief, cooling, soothing, and moistening of the wound site.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three horizontal lines forming its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 1999

Mr. Jay W. Taylor Executive Vice President Nortrade Medical, Inc. 9382 South 670 West Sandy, Utah 84070

Re: K990180

Trade Name: Burnfree Sterile Wound and Burn Dressing K990179 Trade Name: Burnfree 1/8 oz. Sterile Pain Relieving Gel, Model SD K990178 Trade Name: Burnfree Pain Relieving Gel, Model 4B Regulatory Class: Unclassified Product Code: MGQ Dated: July 20, 1999 Received: July 26, 1999

Dear Mr. Taylor:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Jay W. Taylor

This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

[signature]

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

Enclosure

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| Form | B |
|------|---|
|------|---|

## Indications for Use Form

510 (k) Number (if known):

Device Name: BURNFREE STERILE BURN AND WOUND DRESSING (4"x 4", 8"x 8", 16"x 24")

Indications for Use:

- 1. First aid for burns, scalds, cuts, and abrasions.
- 2. Relieves Pain.
- 3. Cools and Soothes.
- 4. Moistens.
- 5. Non-Adherent
- 6. Bacteriostatic

Instructions:

This dressing has been sterilized and must remain sealed until required for use. Do not use if package has been opened or dressing appears dehydrated. Avoid extreme temperatures. Using this package as an outer cover will provide further protection and can easily and painlessly be removed for medical attention.

Warning:

Seek medical attention.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | or |
|------------------------------------------|---------|
| | 4.1 |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | E990180 |

Over-the .- Counter Use X