DERMAGRAN WOUND DRESSING CLEANER W/ZINC
Device Facts
| Record ID | K954743 |
|---|---|
| Device Name | DERMAGRAN WOUND DRESSING CLEANER W/ZINC |
| Applicant | Derma Sciences, Inc. |
| Product Code | FRO · SU |
| Decision Date | Nov 2, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
Device Story
Dermagran Wound Dressing Cleaner with Zinc is a topical wound cleanser. It is intended for use in wound care management. The device is applied to wounds to facilitate cleaning. It is not indicated for use on third-degree burns, nor is it labeled to accelerate wound healing, epithelization, or act as a long-term/permanent dressing or artificial skin. It is not labeled as a treatment or cure for any specific wound type.
Clinical Evidence
No clinical data provided; substantial equivalence determination based on administrative review of 510(k) notification.
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
January 10, 2025
Derma Sciences, Inc.
Howard Enfiejian, Ph.D.
Director of Research and Medical Communications
121 West Grace Street
Old Forge, Pennsylvania 18518
Re: K954743
Trade/Device Name: Dermagran Wound Dressing Cleaner with Zinc
Regulatory Class: Unclassified
Product Code: FRO
Dear Howard Enfiejian, Ph.D.:
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 2, 1995. 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 Yu-Chieh Chiu, OHT4: Office of Surgical and Infection Control Devices, 301-796-6196, Yu-Chieh.Chiu@fda.hhs.gov.
Sincerely,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D.
Assistant Director
DHT4B: Division of Plastic and Reconstructive Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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[LOGO]
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856
NOV - 2 1995
Howard Enfiejian, Ph.D.
Director of Research and
Medical Communications
Derma Sciences, Inc.
121 West Grace Street
Old Forge, Pennsylvania 18518
Re: K954738
Dermagran Hydrophilic Wound Dressing
K954739
Dermagran Hydrophilic Ointment
K954743
Dermagran Wound Cleanser with Zinc
Product Code: KMF
K954740
Dermagran Wound Dressing
K954742
Dermagran Wet Dressing (Zinc-Saline)
Product Code: MGP
Regulatory Class: Unclassified
Dated: October 5, 1995
Received: October 16, 1995
Dear Dr. Enfiejian:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined the devices are substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market your devices subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
1. These devices may not be labeled for use on third degree burns.
2. These devices may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
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3. These devices may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
4. These devices may not be labeled as a treatment or a cure for any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the devices and would require a premarket notification submission (21 CFR 807.81).
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval) they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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 devices in the Federal Register. Please note: this response to your premarket notification submissions 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.
This letter immediately will allow you to begin marketing your devices as described in your 510(k) premarket notifications. An FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and permits your devices to proceed to the market, but it does not mean that FDA approves your devices. Therefore, you may not promote or in any way represent your devices or their labeling as being approved by FDA. If you desire specific advice regarding labeling for your devices in accordance with 21 CFR Part 801, promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Other general information on your responsibilities under the Act may
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be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Kimber C. Richter, M.D.
Acting Director
Division of General and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health
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