SENSITIVE SKIN ANTIBACTERIAL BANDAGES

K032983 · Scivolution, Inc. · FRO · Jun 1, 2004 · SU

Device Facts

• Record ID: K032983
• Device Name: SENSITIVE SKIN ANTIBACTERIAL BANDAGES
• Applicant: Scivolution, Inc.
• Product Code: FRO · SU
• Decision Date: Jun 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

SciVolutions Antibacterial Gentle Care Bandages are to be applied to the skin for topical application for minor cuts and scrapes.

Device Story

Antibacterial Gentle Care Bandages are adhesive bandages for minor cuts and scrapes. The device consists of a non-woven, hydrophobic, latex-free backing and a central absorbent pad impregnated with 1% benzalkonium chloride solution. The pad is covered with an anti-adherent polyethylene veil. The bandage is packaged in a latex-free, cold-sealed kraft paper wrapper. The device is intended for over-the-counter use by patients for self-care. It functions as a physical barrier to protect wounds while delivering a topical antibacterial agent.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-woven hydrophobic backing (latex-free); central absorbent pad impregnated with 1% benzalkonium chloride; anti-adherent polyethylene veil; latex-free kraft paper packaging. Dimensions: 0.75" x 3" and 1" x 3".

Indications for Use

Indicated for topical application on minor cuts and scrapes for the general population.

Predicate Devices

• SciVolutions Various Antibacterial Bandages (K020318)

Submission Summary (Full Text)

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Page 1 of 2

# JUN - 1 2004

### K032983 510(K) SUMMARY (as required by 807.92(c))

| Submitter of 510(k): | SciVolutions, Inc.<br>268 Tosca Dr.<br>Stoughton, MA 02072<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Contact Person: | Alan Nash |
| Date of Summary: | May 14, 2004 |
| Trade Name: | SciVolutions Antibacterial Gentle Care Bandages |
| Classification Name: | Tape and bandage, Adhesive (with disinfectant) |

### Predicate Device:

SciVolutions Various Antibacterial Bandages K020318

#### Indications for Use:

SciVolutions Antibacterial Gentle Care Bandages are to be applied to the skin for topical application for minor cuts and scrapes.

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K032983

### Page 2 of 2 510(k) Summary

#### Device Description

The Antibacterial Gentle Care Bandages uses the identical BZC antibacterial pad as on The Antibactional Gentre Garden ander K020318. Only the backing (non-woven) our providually clours providing a higher water vapor permeability and soft feel.

### Antibacterial Gentle Care Bandages

Non-woven skin color treated hydrophobic backing (Latex Free)

Central pad: High absorption capacity, covered with an anti adherent polyethylene veil, Ochtral pad. Figh abound, impregnated with 1% benzalkonium chloride solution.

Encased in Latex Free Kraft Paper Cold Sealed to make a envelope wrapper

Sizes: .75" x 3" / 1" x 3"

Uses: Gentle Care 25

| In mm-inch | Backing (mm-Inch) | Pad in mm |
|----------------|-------------------|-----------|
| 20x72 - 0.75x3 | 20x72 - 0.75x3 | 10.8x25 |
| 25x72 - 1x3 | 25x72 - 1x3 | 13.6x25 |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a three-tiered wave-like design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2004

SciVolutions, Inc. c/o Mr. Arthur J. Ward RMS. Inc. 962 Allegro Lane Apollo Beach, Florida 33572

Re: K032983

Trade/Device Name: SciVolutions, Inc. Antibacterial Gentle Care Bandages Regulatory Class: Unclassified Product Code: FRO Dated: April 15, 2004 Received: April 26, 2004

Dear Mr. Ward:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becally be device 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 encreatinent date of the Medical Device Amendments, or 10 conninered pror to that 20, 2017) in accordance with the provisions of the Federal Food, Drug, de rices that have been resuire approval of a premarket approval application (PMA). and Cosmetic Act (110) that de nevice, subject to the general controls provisions of the Act. The Tou may, therefore, mailes 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 If your de vice is enashined (soral controls. Existing major regulations affecting your device can may be subject to sach added a legulations, 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 I loast of advised that I Drivieran that your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any it cach stututed and regulations .
comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Hot 010 cm . 10 cm (01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality of evelsions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Arthur J. Ward

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/dsma/dsmamain.html

Sincerely vours,

Miriam C. Provost

(accelia 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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K032983

## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: SciVolutions, Inc. Antibacterial Gentle Care Bandages

Indications For Use:

SciVolutions Antibacterial Gentle Care Bandages are to be applied to the skin for topical application for minor cuts and scrapes.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter 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)

Miriam C. Provost

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

510(k) Number_103298