CARE BAND ANTIBACTERIAL BANDAGES

K983368 · Aso Corp. · KGX · Feb 17, 1999 · General Hospital

Device Facts

• Record ID: K983368
• Device Name: CARE BAND ANTIBACTERIAL BANDAGES
• Applicant: Aso Corp.
• Product Code: KGX · General Hospital
• Decision Date: Feb 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5240
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Antibacterial bandages are to be applied topically to the skin to help prevent infoctlon in minor cuts, scrapes, and burns.

Device Story

Care Band Antibacterial Bandages are adhesive wound dressings designed for topical application to minor cuts, scrapes, and burns. The device functions as a physical barrier to protect wounds from external contaminants while delivering antibacterial agents to the wound site to aid in infection prevention. Intended for over-the-counter use by patients or caregivers in home or clinical settings. The bandage consists of an adhesive backing and an absorbent pad treated with antibacterial components. By maintaining a clean, protected environment, the device supports the natural healing process of minor skin injuries.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Adhesive bandage with antibacterial-treated absorbent pad. Class I device (Product Code: KGX).

Indications for Use

Indicated for topical application to the skin to help prevent infection in minor cuts, scrapes, and burns in the general population.

Regulatory Classification

Identification

A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 1999

Ms. Joan Rubendall Director, Quality Assurance and Regulatory Affairs ASO Corporation 300 Sarasota Center Boulevard Sarasota, Florida 34240

Re: K983368

> Trade Name: Care Band Antibacterial Bandages Regulatory Class: Class I Product Code: KGX Dated: January 6, 1999 Received: January 6, 1999

Dear Ms. Rubendall:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 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 above) into either class II (Special Controls) or class III (Premarket Approval), 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 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 device 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 - Ms. Joan Rubendall

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 your 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 vours.

Sincerely yours,

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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07 Dec 98 0:03PM;Job 74; Page 7/10

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Aso Corporation 510(k) Submission - Antibacterial Bandages Page 4 of 7 Revised: 10/8/1998

## INDICATIONS PAGE

K983368 510(k) Number:

Device Name: Care Band Antibactarial Bandages, as well as other private label brands identified with the customer's name or trade name, such as XYZ Antibacterial Bandages or XYZ Antibacterial Strips.

## INDICATIONS FOR USE:

Antibacterial bandages are to be applied topically to the skin to help prevent infoctlon in minor cuts, scrapes, and burns.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Usc OR Over-the-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Divisit Division of General Restorativ 510(k) Number