HYDROGEL SKIN DRESSING

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION February 25, 2025 North American Sterilization & Packaging Company Charles E. Meisch President 18 White Lake Road P.O. Box 558 Sparta, New Jersey 07871 Re: K962352 Trade/Device Name: Hydrogel Skin Dressing Regulation Number: 21 CFR 878.4022 Regulation Name: Hydrogel wound dressing and burn dressing Regulatory Class: Class I Product Code: NAE Dear Charles E. Meisch: 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 August 2, 1996. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code NAE. 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 {1} [LOGO] DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG - 2 1996 Mr. Charles E. Meisch President North American Sterilization and Packaging Company 18 White Lake Road P.O. Box 558 Sparta, New Jersey 07871 Re: K962352 Hydrogel Skin Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: June 10, 1996 Received: June 18, 1996 Dear Mr. Meisch: 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations: 1. This device may not be labeled for use on third degree burns. 2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization. 3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin. 4. This device 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 device and would require a premarket notification submission (21 CFR 807.81). {2} Page 2 - Mr. Charles E. Meisch 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 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 (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 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. 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597. Sincerely yours, for 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 {3} Page 1 of 1 510(k) Number (if known): K962352 Device Name: Hydrogel Skin Dressing Indications For Use: NAS&P Hydrogel is a crosslinked, water swollen hydrogel polymer consisting of 96% water and 4% crosslinked polyethylene oxide. It is centered by a low density high open area polyethylene net which gives it strength, but does not interfere with transmission of fluids and vapors. It is backed on both sides with an inert low density polyethylene film which controls water vapor transmission during storage and makes the product easy to handle. NAS&P Hydrogel is intended to be used in the management of: 1. Partial thickness draining and non-draining wounds (minor cuts, scrapes, donor sites, etc.) 2. Stage I thru IV chronic wounds such as pressure sores. This hydrogel retains cold temperature. Its high specific heat due to its high water content, allows it to have a cooling effect which may be helpful in relieving pain and itching. It is hydrophilic and will absorb at least 2 times its own weight again in water. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General Restorative Devices 510(k) Number K962352 Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)