BAND-AID(R) BRAND LIQUID BANDAGE

K062602 · Johnson & Johnson Consumer Companies, Inc. · KMF · Dec 11, 2006 · General Hospital

Device Facts

• Record ID: K062602
• Device Name: BAND-AID(R) BRAND LIQUID BANDAGE
• Applicant: Johnson & Johnson Consumer Companies, Inc.
• Product Code: KMF · General Hospital
• Decision Date: Dec 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The intended use of the BAND-AID® brand solvent based Liquid bandage is for providing a covering over minor cuts and scrapes that are clean and dry.

Device Story

Single-use liquid bandage; consists of polymer solution, foam applicator, and aluminum foil pouch. User tears pouch notch; applies solution to minor cuts/scrapes. Solvents evaporate; polymer forms clear, flexible, breathable, waterproof film. Film remains on skin for several days; wears off naturally as wound heals. Used in home/consumer setting. Provides protective barrier to facilitate healing.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Genotoxicity). Bovine Corneal Opacity and Permeability Assay conducted for eye irritancy. Human scarification study performed to assess irritation potential; results showed very low irritation potential.

Technological Characteristics

Solvent-based polymer solution; foam applicator; aluminum foil pouch. Film is clear, flexible, breathable, waterproof. Biocompatible per ISO 10993. Sterilized in bulk or retail carton.

Indications for Use

Indicated for covering minor cuts and scrapes that are clean and dry in general population.

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

• CURAD® Spray Bandage (K022645)
• BAND-AID® Brand Liquid Bandage (K002338)

Submission Summary (Full Text)

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### ડ. 510(k) Summary or 510(k) Statement

page 1 of 2
K062602

## 510(k) Summary

DEC | | 2006

Submitted by: Johnson & Johnson Consumer & Personal Products Company Worldwide, Division of Johnson & Johnson Consumer Companies, Inc. 199 Grandview Road Skillman, NJ 08558 Contact Person: Michelle R. Turk Associate Director, Regulatory Affairs Phone: [phone]

FAX: [phone]

August 21, 2006

Liquid Bandage

Date of Summary Preparation:

Proprietary Name:

Classification (Common) Name:

Device Classification:

Marketed Device(s) to which Equivalency is Claimed:

Description of Device:

21 CFR 880.5090 Regulation Name: Liquid Bandage Regulatory Class: Class I Product Code: KMF

Johnson and Johnson Liquid Bandage

CURAD® Spray Bandage, K022645 Johnson and Johnson LIQUIDERM 110 BAND-AID® Brand Liquid Bandage, K002338

Solvent based liquid bandages are single- use liquid bandages that have three components: polymer solution, a foam applicator and aluminum foil pouch. Inside pouch, the swab is vertically situated with foam head down and saturated by the polymer The pouch is sealed prior to use. solution. The pouch will be open by tearing the notch. Upon

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| | application, the solvents will quickly evaporate and<br>the polymer will form a clear and flexible film to<br>cover skin /wound. The pouches will be sterilized<br>either in bulk or in retail carton. |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The intended use of the BAND-AID® brand<br>solvent based Liquid bandage is for providing a<br>covering over minor cuts and scrapes that are clean<br>and dry. |
| Technological Characteristic: | The liquid bandage is applied to the wound to form<br>a protective barrier. The thin film is clear, flexible,<br>breathable, and waterproof and acts as a protective<br>covering allowing the wound to heal. The film<br>remains on skin for several days, and naturally<br>wears off as wound heals. |
| Evaluation of Substantial<br>Equivalence: | Just as the Curad product, the BAND-AID® brand<br>solvent based Liquid bandage is in liquid form prior<br>to use. Both are a polymeric film formed upon<br>solvent evaporation, have a film that is clear,<br>flexible, breathable, and waterproof, and the film<br>will remain on skin for several days, and naturally<br>wears off as wound heals. If desired, they both can<br>be removed by rubbing alcohol.<br><br>The materials for the BAND-AID® brand solvent<br>based Liquid bandage is biocompatible Per ISO<br>10993 Cytotoxicity, Sensitization,<br>Irritation/Intracutaneous Reactivity, Systemic<br>Toxicity, and Genotoxicity. Additionally, a Bovine<br>Corneal Opacity and Permeability Assay study was<br>conducted to assess potential eye irritancy.<br><br>A Scarification study on humans to assess irritation<br>potential was performed. Both the new and<br>predicate and BAND-AID® Liquid bandage were<br>categorized as being very low for irritation<br>potential. |
| Conclusions | The proposed new Johnson and Johnson Liquid<br>Bandage is substantially equivalent. |

### CONFIDENTIAL

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Johnson & Johnson Consumer Companies % Ms. Michelle R. Turke Associate Director, Regulatory Affairs 199 Grandview Road Skillman, New Jersey 08858

DEC 1 1 2006

Re: K062602

Trade/Device Name: Johnson & Johnson Liquid Bandage Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: November 13, 2006 Received: November 14, 2006

Dear Ms. Turke:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Codc 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); 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.

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Page 2 -- Ms. Michelle R. Turke

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 4. Indications for Use Statement

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# Indications for Use

510(k) Number (if known): Unknown Device Name: Johnson & Johnson Liquid Bandage Indications for Use: The intended use of the BAND-AID® brand solvent based Liquid bandage is for providing a covering over minor cuts and scrapes that are clean and dry

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use <span style="text-decoration: overline;">X</span><br>(21 CFR 801 Subpart C) |
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| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER<br>PAGE OF NEEDED) | | |

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices Page_1_of_1_

| 510(k) Number | L062602 |
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CONFIDENTIAL