CURAD ANTIBACTERIAL BANDAGE

K113583 · Medline Industries, Inc. · FRO · Apr 12, 2012 · SU

Device Facts

• Record ID: K113583
• Device Name: CURAD ANTIBACTERIAL BANDAGE
• Applicant: Medline Industries, Inc.
• Product Code: FRO · SU
• Decision Date: Apr 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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

Device Story

Curad Antibacterial Bandage is a topical wound dressing applied to minor cuts, scrapes, and burns. It functions as a physical barrier to protect wounds from external contaminants while delivering antibacterial agents to the wound site to help prevent infection. Intended for over-the-counter use by patients or caregivers in home or clinical settings. The device provides a protective covering that aids in the healing process of minor skin injuries.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Adhesive bandage incorporating antibacterial agents. Materials include standard medical-grade adhesive, absorbent pad, and backing material. Non-sterile or sterile (as per standard bandage manufacturing). No electronic components or software.

Indications for Use

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

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Medline Industries, Inc. % Mr. Matt Clausen Regulatory Affairs Specialist One Medline Place Mundelein. Illinois 60060

Re: K113583

Trade/Device Name: Curad Antibacterial Bandage Regulatory Class: Unclassified Product Code: FRO Dated: March 23, 2012 Received: March 27, 2012

Dear Mr. Clausen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Of FC Parting (21 CFR 803); good manufacturing practice requirements as set

APR 1 2 2012

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director . Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name:

## Curad Antibacterial Bandage

Indications For Use:

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

Prescription Use (Part 21 CFR 801 Subpart D) OR

Over-the-Counter Use_ ਮ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daide Kimefer NxM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113583