ELASTIC SKIN LIQUID BANDAGE

K032948 · Medpak, LLC · KMF · Jun 25, 2004 · General Hospital

Device Facts

• Record ID: K032948
• Device Name: ELASTIC SKIN LIQUID BANDAGE
• Applicant: Medpak, LLC
• Product Code: KMF · General Hospital
• Decision Date: Jun 25, 2004
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Elastic Skin Liquid Bandage provides a covering over minor cuts and scrapes that are dry and clean.

Device Story

Elastic Skin Liquid Bandage is a film-forming liquid polymer solution applied to minor cuts and scrapes via a brush applicator. Upon application, the solvent evaporates, leaving a clear, protective, flexible, and water-vapor-permeable film. The device is intended for over-the-counter use by patients to protect minor wounds from germs. The film is removed by peeling with mild soap and water. It functions as a physical barrier to external contaminants.

Clinical Evidence

Bench testing only. Testing included: USP<51> self-preservation study; mold and fungus identification; primary skin irritation (rabbits); Ames assay (bacterial mutagenicity); Buehler method (repeated patch dermal sensitization in guinea pigs); L-929 mouse fibroblast cytotoxicity (agarose overlay); and microbial film barrier testing against Pseudomonas aeruginosa ATCC 9027. All tests yielded satisfactory results.

Technological Characteristics

Liquid solution containing organic polymer and organic solvent. Form factor: container with brush applicator. Film-forming mechanism via solvent evaporation. Water vapor permeable. Non-sterile (implied by microbial testing).

Indications for Use

Indicated for covering minor wounds and scrapes 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 (K022645)

Submission Summary (Full Text)

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IJUN 2 5 2004

### 510K SUMMARY FOR

1022

## ELASTIC SKIN LIQUID BANDAGE

### Number K032948

# 1.Manufacturer and Applicant- Medpak LLC, 568 Parkside Court

Allentown, PA18104 Contact Person-Joseph G Sant'Angelo, Phone-484-225-5799; 610-530-0530 E-mail-MJMJJS97 @AOL.COM Date-June 4, 2004

#### 2. Device Name

Proprietary Name: Elastic Skin Liquid Bandage Common Name: Liquid Bandage Classification Information:

#### Class-1

| Name | Product Code | 21 CFR Ref. | Panel |
|----------------|--------------|-------------|---------------------------|
| Liquid Bandage | KMF | 880.5090 | General & Plastic Surgery |

# 3.Predicate Device

CURAD @ Spray Bandage, 510(k) No. K022645

### 4. Device Description

Elastic Skin is a liquid solution film-forming product. The product solution is packaged in a container with a brush applicator. A thin coating of solution is applied on the wound with the applicator forming a protective clear film in less than one minute. Additional coats may be applied if needed. The film may be removed by peeling away from the skin with the use of mild soap and water.

#### Elastic Skin Liquid Bandage composition is as follows:

The main component of Elastic Skin is an organic polymer dissolved in an organic solvent.

### 5. Intended Use

Elastic Skin Liquid Bandage provides a covering over minor cuts and scrapes that are dry and clean.

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The intended use of Elastic Skin Liquid Bandage and CURAD® are the same. Both products use a film forming liquid polymer solution to cover minor wounds on the skin, which forms a clear film on the skin when the solvent evaporates. Both products have many of the same functional characteristics such as helping to protect the minor wounds from germs, while providing flexibility and water vapor permeability.

# 7. Performance Testing

The following laboratory tests where conducted to establish the safety of Elastic Skin Liquid Bandage:

Self Preservation Study-Microorganisms listed in USP<51> Sterility-Mold and Fungus by Agar Plate Count and Identification PRJ Primary Skin Irritation-Rabbits Bacterial Mutagenicity Test-Ames Assay Repeated Patch Dermal Sensitization -Buehler Method. Guinea Pigs 1\$0 Agarose Overlay Using L-929 Mouse Fibroblast Cells (Cytotoxicity Test) Microbial Film Barrier- Psuedomonas Aeruginosa ATCC 9027

All tests gave satisfactory results, indicating that Elastic Skin Liquid Bandage is safe and effective.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2004

Mr. Joseph G. Sant'Angelo President Medpak, LLC 568 Parkside Court Allentown, Pennsylvania 18104

Re: K032948

Trade/Device Name: Elastic Skin Liquid Bandage Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: May 5, 2004 Received: May 6, 2004

Dear Mr. Sant'Angelo:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) premium is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars the Medical Device Amendments, or to commerce prior to May 20, 1978, the enature with the provisions of the Federal Food, Drug, devices that have been reclassified in assessment of a premarket approval application (PMA). allu Cosmetic 71ct (11ct) that do not request of the general controls provisions of the Act. The 1 ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the rist 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 If your device is classified (300 above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major Intay be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obas acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean FICASE be advised that I DPT 3 155aanse or our device complies with other requirements of the Act that TDA has made a decerminations administered by other Federal agencies. You must of ally reciclar statutes and regarations and limited to: registration and listing (21 comply with an the Act 3 requirements, mercansg, suctive requirements as set CTN Fart 807), facemig (21 CFR Part 820); and If applicable, the electronic forth in the quarty systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Joseph G. Sant'Angelo

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin harketing your as rates of your device to a legally premarket notification. The PDA midnig of substanted of the more
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 if you desire specific advice for your ac need and and and the regulation entitled, contact the Office of Complaned at (501) 377 at 807.97). You may obtain " Misbranding by Icierchee to promantee issultities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at the largements httpl Manufacturers, micriational and Ochsailer Press.
[phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

(4) 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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510(k) Number (if known): K032948

Device Name:

Elastic Skin Liquid Bandage

Indications for Use:

Elastic Skin Liquid Bandage is indicated for providing a covering over minor
wounds and scrapes that are gloan and d wounds and scrapes that are clean and dry.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

..

OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Division Division of General, Restorative, and Neurological Devices

**510(k) Number** K032948

(Optional Format 1-2-

December 29, 2003

Annendix D • Pas

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