MARATHON NO STING LIQUID SKIN PROTECTANT

K133443 · Advanced Medical Solutions (Plymouth), Ltd. · KMF · Jul 10, 2014 · General Hospital

Device Facts

• Record ID: K133443
• Device Name: MARATHON NO STING LIQUID SKIN PROTECTANT
• Applicant: Advanced Medical Solutions (Plymouth), Ltd.
• Product Code: KMF · General Hospital
• Decision Date: Jul 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Marathon No Sting Liquid Skin Protectant is intended to protect intact or damaged skin from the effects of moisture, friction, (rubbing) or shear (tearing).

Device Story

Marathon No Sting Liquid Skin Protectant is a topical liquid barrier film applied to skin. It forms a protective layer to shield skin from moisture, friction, and shear forces. Used in clinical or home settings to prevent irritation from bodily fluids, medical adhesives, or mechanical rubbing. Applied by clinicians or patients; dries to form a durable, breathable film. Benefits include skin integrity maintenance and prevention of maceration or mechanical damage.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Liquid barrier film; polymer-based formulation. Applied topically; forms a protective, breathable film upon drying. Class I medical device.

Indications for Use

Indicated for protection of intact or damaged skin against irritation from moisture (urine, feces, digestive juices, perspiration, wound drainage), friction/shear (bedding, clothing, shoes, or rubbing materials), and adhesive products.

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.

Predicate Devices

• Marathon Liquid Skin Protectant (K083566)

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 10, 2014

Advanced Medical Solutions (Plymouth) Ltd Ms. Rose Guang Quality and Regulatory Affairs Director Western Wood Way Plymouth, Devon PL7 5BG UNITED KINGDOM

Re: K133443

Trade/Device Name: Marathon No Sting Liquid Skin Protectant Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: Class I Product Code: KMF Dated: May 30, 2014 Received: June 6, 2014

Dear Ms. Guang:

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

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## Page 2 - Ms. Rose Guang

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# David Krause -S

- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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### Indications for Use Statement

| 510(k) Number (if known): | Not Assigned |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Marathon No Sting Liquid Skin Protectant |
| Intended Use: | Marathon No Sting Liquid Skin Protectant is intended to protect<br>intact or damaged skin from the effects of moisture, friction,<br>(rubbing) or shear (tearing). |

#### Indications for Use:

Marathon No Sting Liquid Skin Protectant helps protect skin exposed to irritation from moisture such as urine, faeces, digestive juices, perspiration and wound drainage. Marathon No Sting Liquid Skin Protectant can also be used in areas that are exposed to friction and shear from bedding, clothing, shoes, or any material that will rub against the skin. Marathon No Sting Liquid Skin Protectant helps protect the skin against irritation caused by adhesive products.

| Prescription Use | AND/OR | Over-The-Counter Use |
|-----------------------------|--------|------------------------|
| YES | | NO |
| (Part 21 CFR 801 Subpart D) | | (21 CFR 801 Subpart C) |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

# Jiyoung Dang -S