3M LIQUID BANDAGE, MODEL 120-LB

K031263 · 3M Company · KMF · Oct 7, 2003 · General Hospital

Device Facts

• Record ID: K031263
• Device Name: 3M LIQUID BANDAGE, MODEL 120-LB
• Applicant: 3M Company
• Product Code: KMF · General Hospital
• Decision Date: Oct 7, 2003
• 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.

Device Story

3M™ Liquid Bandage is a sterile, clear, n-2-butyl cyanoacrylate liquid supplied in an aluminum tube. Applied topically by the consumer to minor cuts, scrapes, and skin irritations, the liquid polymerizes upon contact with skin to form a protective mechanical bond. This thin film acts as a physical barrier to cover the wound, allowing natural healing to occur. The polymer coating naturally sloughs off as dead skin cells are shed during the healing process. The device is intended for home use by the general population.

Clinical Evidence

No clinical trials were performed. Safety evidence consists of bench testing: an In-Vitro Cytotoxicity Test (reactivity grade 1) and a Human Repeat Insult Patch Test (HRIPT) to evaluate contact sensitization, which showed no evidence of induced delayed contact hypersensitivity.

Technological Characteristics

Material: n-2-butyl cyanoacrylate (CAS 6606-65-1). Form factor: Liquid in aluminum tube. Principle: Polymerization upon skin contact to form a mechanical bond/film. Sterilization: Sterile.

Indications for Use

Indicated for over-the-counter (OTC) consumer use to cover minor cuts, scrapes, and skin irritations.

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

• Johnson & Johnson BAND-AID® Liquid Bandage

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most complete and the bottom profile being the least complete.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 2 1 2003

Ms. Anna E. McRight Product Regulation Manager 3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul. Minnesota 55144-1000

Re: K031263

Trade/Device Name: 3MTM Liquid Bandage Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid Bandage Regulatory Class: I Product Code: KMF Dated: July 9, 2003 Received: July 10, 2003

Dear Ms. McRight:

This letter corrects our substantially equivalent letter of October 7, 2003, regarding the Indications for Use Statement.

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 (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 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 - Ms. Anna E. McRight

This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Miriam C. Provost
for S.M. Williams, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological 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): K031263

Device Name: 3M™ Liquid Bandage

### Indications for Use:

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

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter-Use X

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K631263

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K031263

OCT = 7 2003

# Premarket Notification Summary

#### 1. Sponsor Information:

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

Contact Person: Anna E. McRight Product Regulation Manager 3M Health Care

Telephone Number: 651-733-7948 Fax Number: 651-737-5320

#### 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

Johnson & Johnson BAND-AID®1 Liquid Bandage was selected as the predicate device for 3M™Liquid Bandage.

#### Description of Device র্ব

3M™ Liquid Bandage is a sterile, clear, n-2-butyl cyanoacrylate liquid used to cover minor cuts, scrapes, and minor skin irritations. The device is packaged in an aluminum tube with a reusable cap.

Chemical name: n-2-butyl cyanoacrylate CAS registry number: 6606-65-1 Molecular formula: CBH11NO2 Molecular weight (g/mole): 153 Structural formula:

CH3 CN O ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------H2C = C -- C -- O -- CH -- CH2 - CH2 -- CH3

¹ BAND-AID® is a registered trademark of Johnson & Johnson

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#### Indications for Use 5.

3M™ Liquid Bandage is indicated for use as an over-the-counter (OTC) device for consumer use to cover minor cuts, scrapes, and skin irritations.

#### Description of Safety and Substantial Equivalence 6.

Technological Characteristics:

The liguid bandage is applied to the wound and polymerizes to forms a mechanical bond with the skin, typically within one minute. This thin film acts as a 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.

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

A Human Cumulative Irritation Patch Test (HCIPT) was not performed because irritation was adequately tested in the induction phase of the HRIPT. The material was mildly to moderately irritating in a small number of the subjects.

Substantial Equivalence:

3M™ Liquid Bandage is similar to Johnson & Johnson BAND-AID® Liquid Bandage, in that both are cyanoacrylate liquid bandages. They provide the same function and are for over-the-counter (OTC) consumer use. The 3M™ Liquid Bandage is n-2-butyl cyanoacrylate, whereas Johnson & Johnson BAND-AID® Liquid Bandage is 2-octyl cyanoacrylate. The two products are substantially equivalent.