← Product Code [KMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF) · K031263 # 3M LIQUID BANDAGE, MODEL 120-LB (K031263) _3M Company · KMF · Oct 7, 2003 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF/K031263 ## Device Facts - **Applicant:** 3M Company - **Product Code:** [KMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF.md) - **Decision Date:** Oct 7, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5090 - **Device Class:** Class 1 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ### 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. {1}------------------------------------------------ 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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 {2}------------------------------------------------ # 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 {3}------------------------------------------------ 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 {4}------------------------------------------------ #### 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. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF/K031263](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF/K031263) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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