SKIN BARRIER FILM

K092712 · Lodestar Products, Inc. · KMF · Feb 23, 2010 · General Hospital

Device Facts

• Record ID: K092712
• Device Name: SKIN BARRIER FILM
• Applicant: Lodestar Products, Inc.
• Product Code: KMF · General Hospital
• Decision Date: Feb 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Skin Barrier Film is a liquid intended for use as a film-forming product. Upon application to intact or damaged skin, this product forms a long-lasting waterproof barrier, which acts as a protective interface between the skin and bodily wastes, fluids, adhesive products, and friction. It is intended as a primary barrier against irritation from body fluids.

Device Story

Skin Barrier Film is a liquid, film-forming product applied topically to intact or damaged skin. It creates a long-lasting, waterproof protective interface. The barrier shields skin from bodily wastes, fluids, adhesives, and friction, preventing irritation. It is intended for OTC use by patients or caregivers. The device functions as a physical barrier; no complex processing or clinical decision-making is required.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid film-forming product; topical application; waterproof barrier properties.

Indications for Use

Indicated for use on intact or damaged skin to form a waterproof barrier protecting against irritation from bodily wastes, fluids, adhesive products, and friction. Suitable for OTC use.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

FEB 2 3 2010

Lodestar Products, Inc. % Mr. Eric Luo President 6833 Saint Lawrence Street Plano, Texas 75024

Re: K092712

Trade/Device Name: Skin Barrier Film Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: Class I Product Code: KMF Dated: January 19, 2010 Received: January 21, 2010

Dear Mr. Luo:

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 misJeading.

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

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## Page 2 - Mr. Eric Luo

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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): K092712

Device Name: Skin Barrier Film

Indications for Use:

Skin Barrier Film is a liquid intended for use as a film-forming product. Upon application to intact or damaged skin, this product forms a long-lasting waterproof barrier, which acts as a protective interface between the skin and bodily wastes, fluids, adhesive products, and friction. It is intended as a primary barrier against irritation from body fluids.

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use X

(Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krence

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092712