Who is the manufacturer of LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001?

Medlogic Global Limited filed the 510(k) submission for LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001 (K031321).

What is the FDA product code for LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001?

KMF. It is classified under 21 CFR 880.5090 as a Class 1 device in the General Hospital panel.

What is the regulatory pathway for LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001?

510(k) clearance (submission type: Traditional).

What are the predicate devices for LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001?

LIQUIDERM™ Liquid Adhesive Bandage (K002338).

Who can help prepare an FDA 510(k) submission like LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001

K031321 · Medlogic Global Limited · KMF · Jan 21, 2004 · General Hospital

Device Facts

Record ID	K031321
Device Name	LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001
Applicant	Medlogic Global Limited
Product Code	KMF · General Hospital
Decision Date	Jan 21, 2004
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5090
Device Class	Class 1
Attributes	Therapeutic

Intended Use

LiquiShield™ Liquid Bandage is intended for over the counter (OTC) use to cover minor cuts and scrapes and minor irritations of the skin and help protect them from infection.

Device Story

LiquiShield™ Liquid Bandage is a biocompatible, cyanoacrylate-based liquid barrier film. Applied topically to minor skin wounds, it dries within approximately 45 seconds to form a transparent, flexible, waterproof film that adheres to skin contours. The device acts as a physical barrier to protect wounds from dirt and germs while the skin regenerates, eventually wearing off naturally. Supplied sterile for aseptic application, it is intended for OTC use by patients to manage minor cuts, scrapes, and irritations. It provides a protective, haemostatic, and flexible covering, facilitating wound protection without requiring traditional adhesive bandages.

Clinical Evidence

Biocompatibility testing performed per BSENISO 10993-1 confirms safety. Mechanical and performance testing demonstrate equivalence to the predicate. Clinical evaluations were conducted to confirm the device meets its intended use requirements.

Technological Characteristics

Cyanoacrylate-based liquid barrier film. Biocompatible. Sterile, liquid-to-film transformation upon skin contact. Dries in ~45 seconds. Flexible, transparent, waterproof. No electronic components or software.

Indications for Use

Indicated for OTC use to cover minor cuts, scrapes, and minor skin irritations to protect against infection. Contraindicated for burns, infected wounds, deep puncture wounds, animal bites, and serious burns.

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

LIQUIDERM™ Liquid Adhesive Bandage (K002338)

Related Devices

K032948 — ELASTIC SKIN LIQUID BANDAGE · Medpak, LLC · Jun 25, 2004
K053409 — 3M LIQUID BANDAGE · 3M Company · Jun 19, 2006
K171148 — Aleo BME Liquid Bandage · Aleo Bme, Inc. · Jan 12, 2018
K023163 — LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020 · Medlogic Global Limited · Jan 13, 2003
K031263 — 3M LIQUID BANDAGE, MODEL 120-LB · 3M Company · Oct 7, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ JAN 2 1 2004 031321 (P.1042) | Appendix 2 | | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Summary | | | Submitted by: | MedLogic Global Limited, Western Wood Way, Langage Science Park, Plymouth, Devon, PL7 5BG, England | | | Telephone: 44 1752 209955 Fax: 44 1752 209956 | | Contact name: | Richard Stenton, Managing Director | | Date prepared: | 23rd October 2003 | | Device trade name: | LiquiShield™ Liquid Bandage | | Common name: | Liquid Bandage | | Classification name: | Liquid Bandage | | Classification regulation no.: | 880.5090 | | Classification: | Class 1 | | Predicate device: | LIQUIDERM™ Liquid Adhesive Bandage manufactured by Closure Medical Corp., K002338, (Marketed as Johnson & Johnson Band-Aid® Liquid Bandage). | | Intended use: | LiquiShield™ Liquid Bandage is intended for over the counter (OTC) use to cover minor cuts and scrapes and minor irritations of the skin and help protect them from infection. | | Contraindications: | Application to: Burns or wounds with active signs of infection Deep puncture wounds Animal bites Serious burns | : {1}------------------------------------------------ 031321(P.2 of 2) | Description: | LiquiShield™ Liquid Bandage biocompatible cyanoacrylate-based, drying, liquid barrier film for the protection the skin. It is applied as a liquid and dries, within approximately 45 seconds, adhering to the contours of the skin to form a transparent, flexible film. LiquiShield™ Liquid Bandage wears off naturally as the skin regenerates. The applicator and contents are supplied sterile, and the device is, therefore, suitable for aseptic techniques. | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Substantial equivalence: | LiquiShield™ Liquid Bandage is substantially equivalent to the following predicate device: LIQUIDERM™ Liquid Adhesive Bandage manufactured by Closure Medical Corp., K002338, (Marketed as Johnson & Johnson Band-Aid® Liquid Bandage). LiquiShield™ Liquid Bandage is applied as a liquid, which, upon contact with the skin, dries to form a barrier film, which is substantially equivalent to the predicate device. Substantial equivalence is also based on intended use, application, product performance, haemostatic, quick drying, keeps out dirt and germs, waterproof and flexibility properties. | | Testing summary: | LiquiShield™ Liquid Bandage has been subjected to the appropriate biocompatibility testing in accordance with BSENISO 10993-1, the results of which confirm that the product is safe for its intended use. LiquiShield™ Liquid Bandage has also been subjected to mechanical and performance testing to demonstrate equivalence to the predicate device, with clinical evaluations conducted to demonstrate that LiquiShield™ Liquid Bandage meets its intended use requirements. | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines extending from its back, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 1 2004 Mr. Mel Longhurst MedLogic Global Limited Western Wood Way Langage Science Park Plymouth, Devon, PL7 5BG England Re: K031321 Trade/Device Name: Liquishield Liquid Bandage Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: November 7, 2003 Received: November 12, 2003 Dear Mr. Longhurst: 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 – Mr. Mel Longhurst This letter will allow you to begin marketing your device as described in your Scction 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 (301) 594-4659. Also, please note the regulation cntitled. "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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Miriam C. Provost ん( 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 {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): __ K031321 Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use: LiquiShield™ Liquid Bandage is intended to cover minor cuts and scrapes and minor irritations of the skin and help protect them from infection. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use OTC USE (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Muriam C. Provost : · Page 1 of *1* Neurological Devices K031321 ್ತಾರೆ. ಈ ದಿ, Pentorative