ANTIBACTERIAL ADHESIVE BANDAGE

K992817 · William Feinstein & Associates, Inc. · FRO · Nov 5, 1999 · SU

Device Facts

• Record ID: K992817
• Device Name: ANTIBACTERIAL ADHESIVE BANDAGE
• Applicant: William Feinstein & Associates, Inc.
• Product Code: FRO · SU
• Decision Date: Nov 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Antibacterial Adhesive Bandages are to be applied to the skin for topical application. The bandages help prevent infection with minor cuts and scrapes.

Device Story

Antibacterial Adhesive Bandage is a topical dressing applied to skin to cover minor cuts and scrapes. Device functions as a physical barrier to protect wounds while delivering antibacterial agents to prevent infection. Used in home or clinical settings by patients or healthcare providers. Simple adhesive bandage form factor.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on administrative review of device classification.

Technological Characteristics

Adhesive bandage for topical application. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for topical application to the skin to help prevent infection in minor cuts and scrapes in the general population.

Submission Summary (Full Text)

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William Feinstein & Associates, Inc. William Feinstein President 330 East 75th St., Suite 9f New York, New York 10021

Re: K992817 Trade/Device Name: Antibacterial Adhesive Bandage Regulatory Class: Unclassified Product Code: FRO

Dear William Feinstein:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 5, 1999. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code FRO.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, Ph.D., OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, [e-mail].

Sincerely,

Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

November 15, 2021

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 1999

William Feinstein, Ph.D. President William Feinstein & Associates, Inc. 330 East 75th Street, Suite 9F New York, New York 10021

K992817 Re: Trade Name: Antibacterial Adhesive Bandage Regulatory Class: Unclassified Product Code: MXE Dated: August 19, 1999 Received: August 20, 1999

Dear Dr. Feinstein:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - William Feinstein, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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William Feinstein & Associates, Inc. 330 East 75th Street Suite 9F New York, NY 10021

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RE: 510(k) Notification Antibacterial Adhesive Bandage

Page 18

510(k) NUMBER (IF KNOWN): ____________________________________________________________________________________________________________________________________________________

DEVICE NAME: _________________________________________________________________________________________________________________________________________________________________

INDICATIONS FOR USE:

Antibacterial Adhesive Bandages are to be applied to the skin for topical application. The bandages help prevent infection with minor cuts and scrapes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992817