← Product Code [NTC](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NTC) · K030901 # MEDTRADE PRODICT'S SOOTHING GEL PATCH (K030901) _Medtrade Products , Ltd. · NTC · Nov 26, 2004 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NTC/K030901 ## Device Facts - **Applicant:** Medtrade Products , Ltd. - **Product Code:** [NTC](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NTC.md) - **Decision Date:** Nov 26, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5630 - **Device Class:** Class 1 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use To relieve nipples that are sore and cracked from breastfeeding. ## Device Story Soothing Gel Patch is a topical hydrogel dressing applied to the nipple area. It provides a moist environment to soothe and protect sore or cracked nipples resulting from breastfeeding. The device is intended for over-the-counter use by breastfeeding individuals. It functions as a physical barrier and moisture-retaining dressing to facilitate comfort and skin relief. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Hydrogel-based dressing; topical application; non-sterile or sterile (as per standard manufacturing); form factor is a patch designed for nipple coverage. ## Regulatory Identification A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains 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. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 26 2004 Mr. Jonathan Ranfield Director, Quality Assurance & Regulatory Affairs MedTrade Products, Limited Electra House, Crewe Business Park Crewe, Cheshire CW1 6GL United Kingdom Re: K030901 Trade/Device Name: Soothing Gel Patch Regulation Number: 880.5630 Regulation Name: Nursing Pad, Hydrogel Regulatory Class: I Product Code: NTC Dated: September 27, 2004 Received: September 27, 2004 Dear Mr. Ranfield: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Ecderal Register. {1}------------------------------------------------ Page 2 - Mr. Ranfield Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Carls Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ KOCX-1( ## Indications for Use 510(k) Number (if known) K030901 Device Name: MedTrade Product's Soothing Gel Patch Indications for Use: To relieve nipples that are sore and cracked from breastfeeding. Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Anton Drmic (Division Sign-Off) Division of Anesthesiology, General Ho Infection Control, Dental Device 510(k) Number: K --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NTC/K030901](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NTC/K030901) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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