← Product Code FRO · K211123 # LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel (K211123) _Huizhou Foryou Medical Devices Co., Ltd. · FRO · Apr 22, 2022 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K211123 ## Device Facts - **Applicant:** Huizhou Foryou Medical Devices Co., Ltd. - **Product Code:** FRO - **Decision Date:** Apr 22, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Prescription: LUOFUCON® Silver Wound Gel is under the medical supervision of a healthcare professional for the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites. OTC: LUOFUCON® Silver Antimicrobial Wound Gel is indicated for the topical management of minor cuts, minor lacerations and minor burns. ## Device Story Sterile, water-based amorphous gel; composed of hydrophilic polymer and silver compound. Supplied in collapsible polypropylene tube with screw cap. Applied topically to wounds to maintain moist environment; silver compound acts as preservative to inhibit microorganism growth within gel during shelf storage. Used in clinical settings under medical supervision (Rx) or by patients for minor wounds (OTC). Output is physical barrier/moist environment; aids wound healing process; benefits patient by protecting wound site and managing moisture. ## Clinical Evidence No clinical studies conducted. Evidence includes bench testing (absorbency, pH, loss on drying, preservative effectiveness per USP <51>), biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, implantation, material-mediated pyrogenicity per ISO 10993), and a porcine wound healing study showing no inhibition of healing or adverse reactions. ## Technological Characteristics Water-based amorphous gel; ingredients: purified water, Carbopol, glycerol, polyethylene oxide, polyvinyl alcohol, silver compound. pH 5.0-7.5. Silver content 0.007%-0.012% w/w. Moisture donation ≥10%, absorption <10%. Sterile. Packaging: polypropylene tube. ## Predicate Devices - AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B / OTC: AcryDerm Wound Gel Model #B ([K083103](/device/K083103.md)) ## Reference Devices - ASAP OTC Wound Dressing Gel ([K140483](/device/K140483.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}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION". April 22, 2022 Huizhou Foryou Medical Devices CO., Ltd. Huiqi Huang R&D Engineer North Shangxia Rd., Dongjiang Hi-tech Industry Park Huizhou. Guangdong 516005 China Re: K211123 Trade/Device Name: LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: January 24, 2022 Received: February 2, 2022 Dear Huiqi Huang: 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. 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 located 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. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-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-device-advice-comprehensive-regulatoryassistance/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. for Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K211123 #### Device Name LUOFUCON® Silver Wound Gel (Prescription use) LUOFUCON® Silver Antimicrobial Wound Gel (OTC use) #### Indications for Use (Describe) Prescription: LUOFUCON® Silver Wound Gel is under the medical supervision of a healthcare professional for the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites. #### OTC: LUOFUCON® Silver Antimicrobial Wound Gel is indicated for the topical management of minor cuts, minor lacerations and minor burns. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) X 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." {3}------------------------------------------------ K211123 Page 1 of 7 ### 510(k) Summary This 510(k) Summary information is being submitted in accordance with Title 21, CFR Section 807.92. ### 1. SUBMITTER: Huizhou Foryou Medical Devices Co., Ltd. Address: No.1 Shangxia North Road., Dongjiang Hi-tech Industry Park, Huizhou, Guangdong, China. Phone: +86-0752-5302185 Fax: +86-0752-5302020 Contact Person: Huiqi Huang Date Prepared: April 12th, 2021 ### 2. SUBJECT DEVICE Device Name: LUOFUCON® Silver Wound Gel (Prescription use), LUOFUCON® Silver Antimicrobial Wound Gel (OTC use) Common Name or Usual Name: Silver Wound Gel Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Code: FRO ### 3. PREDICATE DEVICE: 510(k) Number: K083103 {4}------------------------------------------------ K211123 Page 2 of 7 Product Name: AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B, OTC: AcryDerm Wound Gel Model #B Manufacturer: AcryMed, Inc. ### 4. REFERENCE DEVICE: 510(k) Number: K140483 Product Name: ASAP OTC Wound Dressing Gel Manufacturer: ABL Medical, LLC ### 5. DEVICE DESCRIPTION: LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is a sterile, water-based amorphous gel composed of hydrophilic polymer and silver compound. The gel helps to maintain a moist wound environment. The silver compound acts as a preservative to inhibit the growth of microorganisms in the gel during shelf storage. LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is supplied in a tube (collapsible, polypropylene tube, sealed on one end and fitted with a screw cap on the other end). ### 6. INDICATIONS FOR USE: ### Prescription: LUOFUCON® Silver Wound Gel is under the medical supervision of a healthcare professional for the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, {5}------------------------------------------------ K211123 Page 3 of 7 surgical incision sites, device insertion site wounds, graft sites, and donor sites. OTC: LUOFUCON® Silver Antimicrobial Wound Gel is indicated for the topical management of minor abrasions, minor cuts, minor lacerations and minor burns. ### 7. COMPARISON WITH THE PREDICATE DEVICE LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel and the predicate device/reference device consist of different ingredients. However, they have the same intended use, similar designs and performance, and meet the biocompatibility requirements. The table below compares the subject device to the predicate and reference devices. | Item | Subject Device
(K211123) | Predicate Device
(K083103) | Reference Device
(K140483) | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | LUOFUCON® Silver
Wound Gel /
LUOFUCON® Silver
Antimicrobial Wound
Gel | AcryDerm Antimicrobial
Silver Gel Model #B /
OTC: AcryDerm Wound
Gel Model #B | ASAP OTC Wound
Dressing Gel | | Classification
Regulation | Unclassified | Unclassified | Unclassified | | Product Code | FRO | FRO | FRO | | Indications for
Use (Rx) | LUOFUCON® Silver
Wound Gel is under
the medical
supervision of a
healthcare professional
for the management of | Under the supervision
of a healthcare
professional, AcryDerm
Silver Antimicrobial
Wound Gel Model #B
is indicated for the | N/A | | | 1st and 2nd degree
burns, wounds such as
stasis ulcers, pressure
ulcers, diabetic ulcers,
lacerations, abrasions,
skin tears, surgical
incision sites, device
insertion site wounds,
graft sites, and donor
sites. | management of 1st and
2nd degree burns,
wounds such as stasis
ulcers, pressure ulcers,
diabetic ulcers,
lacerations, abrasions,
skin tears, surgical
incision sites, device
insertion site wounds,
graft sites, and donor
sites. | | | Indications for
Use (OTC) | LUOFUCON® Silver
Antimicrobial Wound
Gel is indicated for the
topical management of
minor abrasions, minor
cuts, minor lacerations
and minor burns. | AcryDerm Wound Gel
Model #B is indicated
for the management of
minor abrasions, cuts,
lacerations and scalds. | ASAP OTC Wound
Dressing Gel is
indicated for the
topical management
of minor cuts,
lacerations,
abrasions, 1st and
2nd degree burns,
and skin irritations. | | Composition | Purified water,
Carbopol, glycerol,
polyethylene oxide,
polyvinyl alcohol, silver
compound | Hydrophilic polymers
and silver salt | Carbopol ETD 2020,
triethanolamine,
proprietary silver
hydrosol suspension | | Mechanism | Hydrophilic polymer for
maintaining high
moisture content, ionic
silver for reducing
microorganism
colonization within the
dressing during shelf
storage. | Hydrophilic polymer for
maintaining high
moisture content, ionic
silver for reducing
microorganism
colonization within the
dressing during shelf
storage. | Hydrophilic polymer
for maintaining high
moisture content,
silver for reducing
microorganism
colonization within
the dressing during
shelf storage. | | Antimicrobial
agent | Silver compound | Silver compound | Element silver | | | | | | | Appearance | Colorless to light yellow, transparent to slightly cloudy | Slightly cloudy | Clear to golden yellow translucent gel | | pH Value | 5.0-7.5 | N/A | 6.5-8.0 | | Silver Content | $0.007\%-0.012\% w/w$ | N/A | 24ppm | | Moisture Donation | ≥10% | N/A | Greater than 5% | | Moisture Absorption | <10% | N/A | Greater than 5% | | Preservative Performance | USP <51> preservative effectiveness testing | USP <25> preservative assurance testing | USP <51> | | Sterilized | Sterile | N/A | Not provided sterile | {6}------------------------------------------------ # K211123 Page 4 of 7 {7}------------------------------------------------ ### K211123 Page 5 of 7 ### 8. SUBSTANTIAL EQUIVALENCE DISCUSSION LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel has been subjected to ISO 10993 biocompatibility studies to demonstrate the device is as safe as its predicate device. The performance tests were conducted to demonstrate that the subject device is as effective as its predicate device. ### Performance Testing The following performance tests were conducted on subject devices in comparison to the predicate device and the reference device: Appearance Fluid Affinity: EN 13726-1 Test methods for primary wound dressings - Part 1: Aspects of absorbency Loss on Drying: USP <731> Loss on Drying pH Value: USP <791> pH {8}------------------------------------------------ K211123 Page 6 of 7 Preservative Effectiveness: USP <51> Antimicrobial Effectiveness Testing ### Biocompatibility Testing Based on Table A.1 of ISO 10993-1 and Table A.1 of FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices -Part 1_Evaluation and testing within a risk management process", the subject device is categorized as a surface device in contact with breached or compromised surface with prolonged duration. The subject device was evaluated for: - Cytotoxicity Sensitization Irritation Systemic toxicity Implantation Material-mediated pyrogenicity ### Animal Study A Porcine Wound Healing Study was conducted to evaluate the effect of the subject device on the wound healing process. Under the conditions of the study, LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel did not inhibit normal wound healing and did not trigger adverse biological reactions. ### Clinical Studies No clinical study was conducted. {9}------------------------------------------------ # FORY↓↓ MEDICAL K211123 Page 7 of 7 ### 9. CONCLUSIONS Based on the comparison analysis, performance tests, biocompatibility tests and animal study provided in this submission, the subject device, LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is demonstrated to be as safe and effective as the legally marketed predicate device, AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B /OTC: AcryDerm Wound Gel Model #B (K083103). So, the subject device is considered Substantially Equivalent (SE) to the predicate device. --- **Source:** [https://fda.innolitics.com/device/K211123](https://fda.innolitics.com/device/K211123) **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