3M LIQUID BANDAGE

K053409 · 3M Company · KMF · Jun 19, 2006 · General Hospital

Device Facts

• Record ID: K053409
• Device Name: 3M LIQUID BANDAGE
• Applicant: 3M Company
• Product Code: KMF · General Hospital
• Decision Date: Jun 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

3M™ Liquid Bandage is intended to cover minor cuts, scrapes, and skin irritations that are clean and dry.

Device Story

3M™ Liquid Bandage is a sterile, clear, liquid topical product designed for OTC consumer use. It is applied to clean, dry minor cuts, scrapes, and skin irritations. Upon application, the liquid forms a mechanical polymer film barrier that protects the wound site. This film allows the wound to heal and naturally sloughs off as dead skin cells are shed and replaced. The device is supplied in an aluminum tube, a spray pump bottle, or an individually wrapped swab. It functions as a protective covering to facilitate healing.

Clinical Evidence

No clinical trials were performed. Safety was established via bench testing: In-Vitro Cytotoxicity Test (reactivity grade 1), Human Repeat Insult Patch Test (HRIPT) for contact sensitization (no evidence of induced hypersensitivity), and Human Cumulative Irritation Patch Test (HCIPT) (mild material, no evidence of experimental irritation).

Technological Characteristics

Organic polymer-based liquid bandage. Forms a mechanical barrier film. Sterile. Packaging includes aluminum tube, spray pump bottle, or swab. No electronic components or software.

Indications for Use

Indicated for OTC consumer use to cover minor cuts, scrapes, and skin irritations that are clean and dry.

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

Submission Summary (Full Text)

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### Premarket No on Summary

#### 1. Sponsor Information:

3M Consumer Health Care 3M Center: 275-5W-06 St. Paul, MN 55144-1000

Bryan Becker Contact Person: Senior Regulatory Affairs Associate 3M Health Care

651-733-3373 Telephone Number: 651-737-5320 Fax Number:

#### 2. Device Name

| Common or Usual Name: | Liquid Bandage |
|-----------------------|-----------------------------------|
| Proprietary Name: | 3M™ Liquid Bandage |
| Classification Name: | Liquid Bandage (21 CFR §880.5090) |

#### 3. Predicate Device

Curad® Spray Bandage was selected as the predicate device for 3M ™Liquid Bandage.

#### 4. Description of Device

3M™ Liguid Bandage is a sterile, clear, liquid that covers minor cuts and scrapes that are clean and dry. The device is packaged in an aluminum tube with a reusable cap, a bottle with spray pump, or an individually wrapped swab.

#### 5. Indications for Use

3M™ Liquid Bandage is indicated for use as an over-the-counter (OTC) device for consumer use to cover minor cuts and scrapes that are clean and dry.

### 6. Description of Safety and Substantial Equivalence

#### Technological Characteristics

The liquid bandage is applied to the wound to form a mechanical barrier. This thin film acts as a protective covering allowing the wound to heal. During wound healing, the polymer coating sloughs off naturally, as dead skin cells are shed and replaced with new cells.

#### Safety

An In-Vitro Cytotoxicity Test was completed on 3M™ Liquid Bandage to determine the cytotoxicity of the product. The test result was a reactivity grade of 1. In this test the liquid bandage was considered safe for its use.

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A Human Repeat Insult Patch Test (HRIPT) was conducted to evaluate 3M™ Liguid Bandage for the induction of contact sensitization. No evidence of induced delayed contact hypersensitivity was observed.

A Human Cumulative Irritation Patch Test (HCIPT) was performed to evaluate 3M™ Liquid Bandage for the induction of cumulative irritation. The studies that the 3M™ Liquid Bandage is a mild material with essentially no evidence of experimental irritation.

### Substantial Equivalence

3M™ Liquid Bandage is similar to Curad® Spray Bandage, in that both are organic polymer liquid bandages. They provide the same function, are for over-the-counter (OTC) consumer use, have similar claims, and they have the same indications for use. The two products are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, with three lines representing the branches of government and a staff entwined by a serpent, representing healing and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 19 2006

3M Company % Mr. Bryan Becker Senior Regulatory Affairs Associate 3M Center, Building 275-05-W-06 St. Paul, Minnesota 55144-1000

Re: K053409

Trade/Device Name: 3M™ Liquid Bandage Regulatory Number: 21 CFR 880.5090 Regulatory Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: May 17, 2006 Received: May 23, 2006

Dear Mr. Becker:

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 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); 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 -- Mr. Bryan Becker

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,

Hulu Lemus
Mark N. Melkerson

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

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# Indications for Use Statement

510(k) Number (if known): Kos3409 Device Name: 3M™ Liquid Bandage

Indications for Use:

3M™ Liquid Bandage is intended to cover minor cuts, scrapes, and skin irritations that are clean and dry.

Prescription Use

OR

Image /page/4/Picture/7 description: The image contains the text 'Over-The-Counter-Use' in a simple, sans-serif font. To the right of the text is a large 'X' symbol, which is underlined. The text and symbol are black against a white background.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulin Lewis

(Division Division of General, Restorative. and Neurological Devices

3409 510(k) Number.

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