← Product Code [NAD](/productcode/NAD) · K254246 # LT Antibacterial Foam with Silver Dressing (K254246) _Zhejiang Longterm Medical Technology Co., Ltd. · NAD · Sep 10, 2026 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K254246 ## Device Facts - **Applicant:** Zhejiang Longterm Medical Technology Co., Ltd. - **Product Code:** [NAD](/productcode/NAD.md) - **Decision Date:** Sep 10, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4020 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use LT Antibacterial Foam with Silver Dressing is indicated for management acute and chronic wounds with moderate to heavy exudate, including stage II, III and IV pressure ulcers, leg ulcers and diabetic foot ulcers. The dressing can also be used for partial thickness burns (including first- and superficial second-degree burns), donor sites, post operative wounds and skin abrasions. LT Antibacterial Foam with Silver Dressing is intended for external use only. ## Device Story Advanced wound care dressing; porous polyurethane foam structure; silver-impregnated for antimicrobial activity; activated carbon for odor control; optional polyurethane film backing. Absorbs and retains wound exudate; maintains moisture balance; silver inhibits bacterial growth (4-log activity for up to 7 days). Used in clinical or home settings; applied by healthcare professionals or patients. Output is physical wound coverage and exudate management; aids healing by maintaining optimal environment and reducing bacterial load. ## Clinical Evidence Bench testing included antimicrobial performance (AATCC 100), physical performance (EN 13726-1, ASTM D3574), and biocompatibility (ISO 10993). Animal testing: GLP-compliant porcine wound healing study compared subject device to Biatain Ag Foam and dry gauze control; demonstrated comparable wound healing with no adverse tissue response. ## Technological Characteristics Materials: Polyurethane film, silver-impregnated polyurethane foam, activated carbon. Energy: None. Form factor: Multi-size foam sheets with/without film backing. Sterilization: Gamma irradiation (ISO 11137-2). Connectivity: None. Mechanical properties: Water absorbency (EN 13726-1), wet tensile strength (ASTM D3574). ## Regulatory Identification An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources. ## Predicate Devices - Biatain Ag Foam Dressing ([K100218](/device/K100218.md)) ## 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} FDA U.S. FOOD & DRUG ADMINISTRATION September 10, 2026 Zhejiang Longterm Medical Technology Co., Ltd. Claudia Zsang Director of Regulatory Affairs Shuangshan Rd. 277, Fuxi St. Deqing, Zhejiang 313200 China Re: K254246 Trade/Device Name: LT Antibacterial Foam with Silver Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 8, 2026 Received: August 10, 2026 Dear Claudia Zsang: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254246 - Claudia Zsang Page 2 Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. {2} K254246 - Claudia Zsang Page 3 For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, MUSTAFA A. MAZHER -S For 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 Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K254246 Device Name LT Antibacterial Foam with Silver Dressing Indications for Use (Describe) LT Antibacterial Foam with Silver Dressing is indicated for management acute and chronic wounds with moderate to heavy exudate, including stage II, III and IV pressure ulcers, leg ulcers and diabetic foot ulcers. The dressing can also be used for partial thickness burns (including first- and superficial second-degree burns), donor sites, post operative wounds and skin abrasions. LT Antibacterial Foam with Silver Dressing is intended for external use only. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. **\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} 510(k) #: k254246 # 510(k) Summary Prepared on: 2026-08-08 ## Contact Details 21 CFR 807.92(a)(1) Applicant Name Zhejiang Longterm Medical Technology Co., Ltd Applicant Address ShuangShan Road 277, Fuxi Street Deqing Zhejiang 313200 China Applicant Contact Telephone 1-647-991-3316 Applicant Contact Ms. Claudia Zsang Applicant Contact Email claudia.zsang@gmail.com ## Device Name 21 CFR 807.92(a)(2) Device Trade Name LT Antibacterial Foam with Silver Dressing Common Name Foam dressing with silver Classification Name Occlusive wound dressing Regulation Number Unclassified Product Code(s) FRO ## Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K100218 Biatain Ag Foam Dressing FRO ## Device Description Summary 21 CFR 807.92(a)(4) LT Antibacterial foam with Silver Dressing is an advanced wound care dressing and is available in two configurations: with or without a polyurethane film backing. Multiple sizes are available to accommodate various wound dimensions. The porous structure provides rapid absorption and retention of wound exudate, helping to maintain an optimal moisture balance. The activated carbon incorporated in the foam absorbs wound odor. Upon contact with wound fluid, the silver inhibits bacterial growth within the dressing. The soft, elastic foam conforms to wound contours. The presence of silver can provide 4-log antibacterial activity for up to 7 days within the dressing against gram-negative and gram-positive bacteria, such as Klebsiella pneumoniae, Pseudomonas Aeruginosa, Escherichia coli, Streptococcus epidermidis, Enterococcus faecium and Staphylococcus aureus. ## Intended Use/Indications for Use 21 CFR 807.92(a)(5) LT Antibacterial Foam with Silver Dressing is indicated for management acute and chronic wounds with moderate to heavy exudate, including stage II, III and IV pressure ulcers, leg ulcers and diabetic foot ulcers. The dressing can also be used for partial thickness burns (including first- and superficial second-degree burns), donor sites, post operative wounds and skin abrasions. LT Antibacterial Foam with Silver Dressing is intended for external use only. {5} # Indications for Use Comparison 21 CFR 807.92(a)(5) The subject device has the following indications for use, which are similar to those of the predicate device (Biatain Foam Silver, K100218):Indications for Use:LT Antibacterial Foam with Silver Dressing is indicated for management acute and chronic wounds with moderate to heavy exudate, including stage II, III and IV pressure ulcers, leg ulcers and diabetic foot ulcers. The dressing can also be used for partial thickness burns (including first- and superficial second-degree burns), donor sites, post operative wounds and skin abrasions. The device is intended for external use only. # Technological Comparison 21 CFR 807.92(a)(6) Both devices share similar indications for use, fundamental scientific technology, major materials composition, and performance characteristics. Indications for Use: Both the subject and predicate devices are indicated for the management of moderate to heavily exuding acute and chronic wounds, including pressure ulcers (Stage II, III, and IV), leg ulcers, diabetic foot ulcers, donor sites, postoperative wounds, skin abrasions, and partial-thickness burns. Both devices are intended for external use only and provide antimicrobial activity within the dressing. Technological Characteristics: The subject device is composed of Polyurethane film and silver-impregnated polyurethane foam with activated carbon for odor control, and the predicate consists of PU film and silver-impregnated PU foam. Both devices utilize the same antimicrobial agent (silver), and the same base material (polyurethane foam). The subject device is available in two configurations—with and without polyurethane film backing—to accommodate different wound types, identical to the predicate device's product line. The configuration with film backing provides a semi-permeable barrier to prevent exudate strike through. These design features and clinical applications are identical to those of the predicate device. The minor difference in material composition, specifically the inclusion of activated carbon, does not impact the foam's ability to absorb wound exudate or the antibacterial activity of silver within the dressing. Activated carbon is a well-established safe material with a history of safe use in wound dressings, where it is commonly incorporated for wound odor management. Performance Characteristics: Comparative performance testing demonstrates that the subject device performs equivalently to the predicate device across all critical performance parameters, including absorption capacity, fluid retention under pressure, silver elution rate, antimicrobial efficacy, and tensile strength. Biocompatibility evaluation: The biocompatibility evaluation for the LT Antibacterial Foam Dressing with Silver was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices-part1: Evaluation and testing within a risk management process'", both devices are categorized as prolonged contact with breached/ compromised skin. Sterility: Both devices are terminally sterilized using gamma irradiation in accordance with ISO 11137. The devices are packaged in sealed pouches that maintain sterility throughout the labeled shelf life. The LT Antibacterial Foam with Silver Dressing is substantially equivalent to the predicate device Biatain Foam Silver (K100218) based on similar indications for use, the similar fundamental scientific technology, comparable materials composition, equivalent performance characteristics, and similar biocompatibility profiles. The minor differences in material composition and sizes do not alter the device's fundamental technological characteristics or raise different questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate device and is as safe and effective as the legally marketed predicate for its intended use. # Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Antimicrobial Performance Testing - Pass - Antimicrobial Activity (AATCC 100) - Minimum Effective Concentration (AATCC 100) - Silver Content (AAS) - Silver Elution (AAS) Physical Performance Testing - Pass - Water Absorbency (EN 13726-1) - Fluid Retention - Wet Tensile Strength (ASTM D3574:2008)- - pH Value (USP <791>, ISO 10993-12) Animal Testing A GLP-compliant porcine wound healing study compared the subject device to the predicate device (Biatain Ag Foam) and a dry gauze control. The subject device demonstrated wound healing comparable to the predicate device with adequate performance and no evidence of delayed healing or adverse tissue response. {6} # Sterilization and Packaging - Sterilization Method (ISO 11137-2:2013, VDmax25) - Sterility Assurance Level (ISO 11137-2:2013) - Package Seal Strength (ASTM F88/F88M-23) - Package Integrity (ASTM F3039-15) # Biocompatibility Testing - Pass The LT Antibacterial Foam with Silver Dressing was evaluated for biocompatibility per ISO 10993-1 requirements for a surface device with prolonged contact. Testing included: - Cytotoxicity (ISO 10993-5:2009, MEM Elution) - Sensitization (ISO 10993-10:2010, Guinea Pig Maximization Test) - Irritation (ISO 10993-10:2010, Intracutaneous) - Implantation (ISO 10993-6:2016, 4-week intramuscular) - Acute Systemic Toxicity (ISO 10993-11:2017) - Subacute/Subchronic Toxicity (ISO 10993-11:2017, 28-day rat study) - Pyrogenicity (ISO 10993-11:2017 / USP <151>) --- **Source:** [https://fda.innolitics.com/device/K254246](https://fda.innolitics.com/device/K254246) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com