← Product Code [FRL](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRL) · K121898 # STAY FRESH SKIN FOLD MANAGEMENT TEXTILE (K121898) _Quick-Med Technologies, Inc. · FRL · May 24, 2013 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRL/K121898 ## Device Facts - **Applicant:** Quick-Med Technologies, Inc. - **Product Code:** [FRL](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRL.md) - **Decision Date:** May 24, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5300 - **Device Class:** Class 1 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The Stay Fresh Skin Fold Management Textile is a skin protectant intended to be used between skin folds and in other skin-to-skin contact areas to provide moisture management and reduce friction. The Stay Fresh Skin Fold Management Textile contains hydrogen peroxide, which reduces bacterial populations in the fabric. ## Device Story Stay Fresh Skin Fold Management Textile is a non-sterile, single-patient-use polyester fabric designed for placement between skin folds or contact areas. Device functions by wicking moisture away from skin and providing a low-friction surface to prevent irritation. Fabric is impregnated with hydrogen peroxide to reduce bacterial populations within the textile. Intended for use in clinical or home settings to manage skin fold environments. Healthcare providers or patients cut the fabric from a multi-use package to fit the specific area. By maintaining a dry, low-friction, and reduced-bacteria environment, the device aids in skin protection and management of skin-to-skin contact issues. ## Clinical Evidence Bench testing only. Performance testing assessed biocompatibility, moisture management capabilities, and antimicrobial properties of the textile. ## Technological Characteristics Polyester fabric; non-sterile; single-patient use; contains hydrogen peroxide as an antimicrobial agent; moisture-wicking and low-friction surface properties; dimensions 25.4 cm x 365.8 cm. ## Regulatory Identification A medical absorbent fiber is a device intended for medical purposes that is made from cotton or synthetic fiber in the shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category. ## Predicate Devices - Milliken Interdry Textile with Silver ([K110715](/device/K110715.md), [K061615](/device/K061615.md)) - ConvaTec SurePress® Absorbent Padding ## 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}------------------------------------------------ K121898 ## 510(k) Summary for the Quick-Med Technologies, Inc. Stay Fresh Skin Fold Management Textile MAY 2 4 2013 ### 1. SUBMITTER/510(K) HOLDER Quick-Med Technologies, Inc. 902 NW 4th Street Gainesville, FL 32601 352-379-0611 352-379-1099 (fax) Contact Person: Susan Leander Telephone: 352-379-0611 Date Prepared: May 24, 2013 #### 2. DEVICE NAME | Proprietary Name: | Stay Fresh™ Skin Fold Management Textile | |----------------------------|------------------------------------------| | Common/Usual Name: | Skin Protectant | | Classification Name: | Medical absorbent fiber | | Classification Regulation: | 21 CFR 880.5300 | | Product Code: | FRL | ### 3. PREDICATE DEVICES - · Milliken Interdry Textile with Silver subject of K110715, K061615 - · ConvaTec SurePress® Absorbent Padding which is listed with the FDA by Convatec #### 4. DEVICE DESCRIPTION Stav Fresh Skin Fold Management Textile is a non-sterile skin protectant indicated for management of skin folds and other skin-to-skin contact areas, such as extremities, and is offered as a 25.4 cm x 365.8 cm fabric piece (other sizes may also be available). The device provides moisture management to keep skin dry and the device's low coefficient of friction reduces skin-to-skin friction. Stay Fresh Skin Fold Management Textile is a single patient use product that is custom cut from a multiuse package. Polyester fabrics are well known to wick moisture away from skin as well as provide a low friction surface. {1}------------------------------------------------ #### 5. INTENDED USE The Stay Fresh Skin Fold Management Textile is a skin protectant intended to be used between skin folds and in other skin-to-skin contact areas to provide moisture management and reduce friction. The Stay Fresh Skin Fold Management Textile contains hydrogen peroxide, which reduces bacterial populations in the fabric. ### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE The Stay Fresh Skin Fold Management Textile is substantially equivalent to the predicate devices with respect to material composition, device characteristics and intended use. ### 7. PERFORMANCE TESTING The Stay Fresh Skin Fold Management Textile has been subjected to extensive testing to assess the biocompatibility and the performance of the Stay Fresh Skin Fold Management Textile was shown to provide moisture management and antimicrobial properties. {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 24, 2013 Quick-Med Technologies, Incorporated Ms. Susan E. Leander, M.S. Regulatory Affairs Coordinator 902 North West, 4th Street GAINESVILLE, FL 32601 Re: K121898 Trade/Device Name: Stay Fresh Skin Fold Management Textile (SFMT) Regulation Number: 21 CFR 880.5300 Regulation Name: Medical Absorbent Fiber Regulatory Class: I Product Code: FRL Dated: May 15, 2013 Received: May 17, 2013 Dear Ms. Leander: 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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Federal Register. {3}------------------------------------------------ Page 2 - Ms. Leander 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm. Image /page/3/Picture/7 description: The image shows a signature and some text. The text includes the phrase "Sincerely yours," followed by a signature that is difficult to read. To the right of the signature, the text "Tejashri" and "Clinical D" are visible, along with the word "DAGRID". Tejashri Purohit-Sheth, M.D. Clinical Deputy Director Anthony D. Watson, B.S., M.S., M.B.A. . Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health #### Enclosure {4}------------------------------------------------ # QMT K121898 # Indications for Use #### 510(k) Number (if known): K121898 Device Name: Stay Fresh Skin Fold Management Textile (SFMT) Indications for Use: The Stay Fresh Skin Fold Management Textile is a skin protectant intended to be used between skin folds and in other skin contact areas to provide moisture management and reduce friction. The Stay Fresh Skin Fold Management Textile contains hydrogen peroxide, which reduces bacterial populations in the fabric. | Prescription Use | X | |-----------------------------|---| | (Part 21 CFR 801 Subpart D) | | . AND/OR Over-The-Counter Use X (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) · | | | | Date: | Division Sign-Off) livision of Anesthesiology, General Hospital infection Control, Dental Devices . 2013.05.24 13:20:56 -04'00' 510(k) Number: KI21898 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRL/K121898](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRL/K121898) **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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