Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch

Q: Who is the manufacturer of Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch?

Speciality Fibres and Materials, Ltd. filed the 510(k) submission for Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch (K222740).

Q: What is the FDA product code for Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch?

FRO. as a Class U device in the SU panel.

Q: What is the regulatory pathway for Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch?

Titan Ag 200 (K173844); Aquacel Ag Extra (K121275); Aquacel Ag+ Extra (K173675); Kerracel Ag (K162508).

Q: Who can help prepare an FDA 510(k) submission like Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K222740 · Speciality Fibres and Materials, Ltd. · FRO · Oct 21, 2024 · SU

Device Facts

Record ID	K222740
Device Name	Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch
Applicant	Speciality Fibres and Materials, Ltd.
Product Code	FRO · SU
Decision Date	Oct 21, 2024
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

Under the supervision of a healthcare professional, Venus Ag may be used for the management of: - wounds with moderate to heavy exudate - partial thickness burns - leg ulcers, pressure ulcers and diabetic ulcers - surgical wounds (e.g. post-operative, wounds left to heal by secondary intent and donor/graft sites) - traumatic wounds (e.g. abrasions and lacerations) - wounds that are prone to bleeding, such as wounds that have been mechanically debrided and donor sites. The product is for a single use only.

Device Story

Venus Ag (120, 160, 200) is a sterile, non-woven wound dressing composed of sodium carboxymethyl cellulose, strengthening cellulose fibers, and elemental silver nanoparticles. Used in clinical settings under healthcare professional supervision, the dressing is applied to wounds to manage exudate. Upon contact with wound fluid or blood, the dressing absorbs exudate and forms a gel, maintaining a moist environment that supports autolytic debridement and protects surrounding skin from maceration. The silver nanoparticles release ionic silver into the dressing, providing an antimicrobial effect that inhibits bacterial colonization within the dressing. The dressing retains debris and bacteria, which are removed during dressing changes. It can be cut to size when dry. The device benefits patients by managing exudate, reducing infection risk via antimicrobial action, and facilitating healing.

Clinical Evidence

No clinical testing performed. Evidence includes bench testing (antimicrobial efficacy per modified AATCC 100, silver release profiles, absorbency per BP/EN13726-1, tensile strength), biocompatibility (ISO 10993-1, -5, -10, -11, -17), and a porcine wound healing study (ISO 10993-6) comparing Venus Ag to Aquacel Ag+ Extra, showing no impairment of healing.

Technological Characteristics

Non-woven pad/ribbon dressing; materials: sodium carboxymethyl cellulose, strengthening cellulose fibers, elemental silver nanoparticles. Dimensions/weights vary. Sterilization: Gamma radiation. Packaging: Foil pouch. Connectivity: None (standalone).

Indications for Use

Indicated for management of moderate to heavy exudate wounds, partial thickness burns, leg/pressure/diabetic ulcers, surgical wounds (post-op, secondary intent, donor/graft sites), and traumatic wounds (abrasions/lacerations) prone to bleeding. Contraindicated in individuals with sensitivity or allergic reaction to dressing components.

Predicate Devices

Titan Ag 200 (K173844)
Aquacel Ag Extra (K121275)
Aquacel Ag+ Extra (K173675)
Kerracel Ag (K162508)

Related Devices

K173844 — Titan Ag 200 · Specialty Fibres and Materials, Ltd. · Aug 9, 2018
K013814 — ABSORBENT ANTIMICROBIAL WOUND DRESSING · Convatec, A Division of E.R. Squibb & Sons · Jun 21, 2002
K210466 — Silver Gelling Fiber Dressing · Winner Medical Co., Ltd. · Jan 14, 2022
K221720 — Extra Silver Gelling Fiber Dressing · Winner Medical Co., Ltd. · Dec 21, 2022
K081363 — NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING · Advanced Medical Solutions Limited · Sep 24, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. October 21, 2024 Speciality Fibres and Materials Ltd. Nyerngoor Hewitt Director of Regulatory Affairs and Ouality Galaxy House Binley Industrial Estate, 31 Herald Way Coventry, West Midlands CV6 5SF United Kingdom Re: K222740 Trade/Device Name: Venus Ag 120 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. Venus Ag 160 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. Venus Ag 200 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. Regulatory Class: Unclassified Product Code: FRO Dated: September 8, 2022 Received: September 9, 2022 Dear Nyerngoor Hewitt: 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. {1}------------------------------------------------ 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). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. {2}------------------------------------------------ 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/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-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, # 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 Enclosure {3}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K222740 #### Device Name Venus Ag 120 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. Venus Ag 160 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. Venus Ag 200 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. Indications for Use (Describe) Under the supervision of a healthcare professional, Venus Ag may be used for the management of: - · wounds with moderate to heavy exudate - · partial thickness burns - · leg ulcers, pressure ulcers and diabetic ulcers - · surgical wounds (e.g. post-operative, wounds left to heal by secondary intent and donor/graft sites) - · traumatic wounds (e.g. abrasions and lacerations) - wounds that are prone to bleeding, such as wounds that have been mechanically debrided and donor sites. The product is for a single use only. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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." {4}------------------------------------------------ # 510(k) Summary (Venus Ag) Details of the device Venus Ag herewith applied for is as follows: ## 5.1 Administrative Information | Applicant | Speciality Fibres and Materials Limited, Galaxy House, Binley Industrial Estate, 31 Herald Way, Coventry CV3 2RQ, United Kingdom | | |-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Official Correspondent and Contact Details | Nyerngoor Korda Hewitt Director of Regulatory Affairs and Quality Telephone: +44 (0) 2476 708 229, +44 (0) 7725 786 717 E-mail: nyerngoor.kordahewitt@sfm-limited.com | | | Date Prepared | Initial 29 October 2021, 1st October 2024 Updated | | | Device Details | 510(k) Number | K222740 | | | Product Name(s) | Venus Ag 120 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. Venus Ag 160 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. Venus Ag 200 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. | | | Classification Name | Unclassified | | | Product Code | FRO | | | Panel | General & Plastic Surgery | | | Combination | Yes, the device is a combination product | | Legally Marketed Predicate Device(s) | Primary Predicate Device: Titan Ag 200 K173844 Additional Predicate Devices: Aquacel Ag Extra K121275 Aquacel Ag+ Extra K173675 Kerracel Ag K162508 | | {5}------------------------------------------------ #### 5.2 Description of the Device Venus Ag 120, 160 and 200 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber are a soft, conformable non-woven fabrics made from sodium carboxymethyl cellulose and strengthening cellulose fiber(s) with antimicrobial silver. The silver in the wound dressing, when in contact with wound exudate or blood present in wound exudate, has an antimicrobial effect on bacteria held within the dressing, preventing it from being colonized. The absorption of exudate into the dressing forms a gel which assists in maintaining a moist wound environment, supporting autolytic debridement, protects the wound edge and surrounding skin from maceration. Through the gel formation the structure of the dressing remains intact. Debris and any bacteria found in the wound exudate can be retained inside the dressing and removed when the dressing is changed. When dry, Venus Ag can easily be cut to the size of the wound. The device is a combination product, code FRO. Venus Ag dressings are supplied in a variety of sizes, configurations, and weights. {6}------------------------------------------------ ## 5.3 Indications for Use Under the supervision of a healthcare professional, Venus Aq may be used for the management of: - Wounds with moderate to heavy exudate - Partial thickness burns ● - Leg ulcers, pressure ulcers and diabetic ulcers . - Surgical wounds (e.g. post-operative, wounds left to heal by secondary intent . and donor/graft sites) - . Traumatic wounds (e.g. abrasions and lacerations) - Wounds that are prone to bleeding, such as wounds that have been . mechanically or surgically debrided and donor sites The product is for a single use only. ## 5.4 Summary of Technological Characteristics Venus Ag technological characteristics are deemed comparable to those of the predicate devices. Venus Ag has the same intended use and general characteristics as the predicate devices as detailed in the table below. Minor technological differences are addressed in Table 5-1. {7}------------------------------------------------ | Device Name | Venus Ag | Titan Ag 200 | Aquacel Ag Extra | Aquacel Ag+ Extra | Kerracel Ag | Significant Differences / Justification for Equivalence | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | SFM Ltd | SFM Ltd | Convatec Inc | Convatec Inc | Crawford | N/A | | Identification | Subject Device | Primary Predicate Device | Additional Predicate Device | Secondary Predicate | Additional Predicate Device | N/A | | 510(k) Number | K222740 | K173844 | K121275 | K173675 | K162508 | N/A | | Product Code | FRO | FRO | FRO | FRO | FRO | Equivalent. | | Regulation Name | Dressing, Wound, Drug | Dressing, Wound, Drug | Dressing, Wound, Drug | Dressing, Wound, Drug | Dressing, Wound, Drug | Equivalent. | | Intended Use | Management of wounds with moderate to heavy exudate. The dressing absorbs wound exudate, forms a gel, and may retain bacteria in the wound exudate within the dressing. This ensures a moist wound healing environment. The dressing also has an antimicrobial action which is exerted by the silver released into the dressing. | Management of wounds with moderate to heavy exudate. The dressing absorbs wound exudate and may retain bacteria in the wound exudate within the dressing. This ensures a moist wound healing environment. The dressing contains silver, which limits the growth of bacteria within the dressing. | This conformable and highly absorbent dressing absorbs wound fluids, creating a soft gel which maintains a moist environment and supports the body's healing process. | This dressing absorbs wound fluid and creates a soft gel that conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement). A moist wound environment supports the body's healing process. The silver preservative in the dressing provides an effective barrier to bacterial penetration of the dressing as this may help reduce infection. | The silver in the dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing for up to seven days. Absorbs high amounts of wound fluid and creates a soft cohesive gel that intimately conforms to the wound surface and maintains a moist wound healing environment. | Substantially Equivalent. Venus Ag has an Antimicrobial claim which is addressed in Section 18. Risk of infection are not within the scope of the Venus Ag indications. | | Indications for Use | Management of wounds with moderate to heavy exudate | Management of wounds with moderate to heavy exudate | Management of wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection | Aquacel Ag+ Extra dressings are indicated for: | Management of acute and chronic, partial and full thickness wounds including pressure ulcers, leg ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, first and second degree burns. | Equivalent to primary predicate. Malignant wounds in the additional predicate are not within the scope of the Venus Ag indications. | | | Partial thickness burns | Partial thickness burns | Partial thickness (second degree) burns | Partial thickness burns | | | | | Leg ulcers, pressure ulcers and diabetic ulcers | Leg ulcers, pressure ulcers and diabetic ulcers | Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and | Leg ulcers, including: Venous stasis ulcers Arterial ulcers. Legs ulcers of mixed aetiology Diabetic foot ulcers. Pressure ulcers/injuries | and second degree burns. | | | Device Name | Venus Ag | Titan Ag 200 | Aquacel Ag Extra | Aquacel Ag+ Extra | Kerracel Ag | Significant Differences / Justification for Equivalence | | Manufacturer | SFM Ltd | SFM Ltd | Convatec Inc | Convatec Inc | Crawford | N/A | | | | | pressure ulcers/sores (partial and full thickness); | | | | | | Surgical wounds (e.g. post- operative wounds left to heal by secondary intent and donor/graft sites) | Surgical wounds (e.g. post- operative wounds left to heal by secondary intent and donor/graft sites) | Surgical wounds left to heal by secondary intention such as dehisced surgical incisions; Surgical wounds that heal by primary intent such as dermatological and surgical | Surgical wounds | | | | | | | incisions (e.g. orthopedic and vascular) | | | | | | Traumatic wounds (e.g. abrasions and lacerations) | Traumatic wounds (e.g. abrasions and lacerations) | Traumatic wounds | Traumatic wounds | | | | | Wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided and donor sites | Wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided and donor sites | Wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided and donor sites | Surgical wounds | | | | | | | Painful wounds; Infected wounds | | | | | | | | | Malignant wounds | | | | Contra indications | Should not be used on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components. | Should not be used on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components. | Should not be used on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components. | Aquacel Ag+ Extra dressings should not be used on individuals who are sensitive to or have had an allergic reaction to silver, sodium carboxymethyl cellulose ethylenediaminetetraacetic acid di-sodium salt (EDTA) or benzethonium chloride (BECI) | Individuals with a known allergy or hypersensitivity to any of the components of KerraCel® Ag should not use the dressing. | Equivalent with primary device. | | Prescription Use | Prescription Use | Prescription Use | OTC use Prescription Use | OTC use Prescription Use | Prescription Use | Equivalent with primary predicate device. | | Maximum Period of Use | Seven days per dressing and maximum repeat dressings of 30 days | Seven days per dressing and maximum repeat dressings of 30 days | Seven days per dressing and maximum repeat dressings of 30 days | Aquacel Ag+ Extra dressings can be worn for up to seven days. Dressings should be changed earlier if clinically indicated. On partial thickness (second degree) burns, dressings may remain in place for up to 14 days. The requirement for Aquacel Ag+ Extra dressings should be re- assessed after 14 days and alternative wound management considered where appropriate | The dressing can be left in place for up to seven days. | Equivalent with primary predicate device. | | Device Name | Venus Ag | Titan Ag 200 | Aquacel Ag Extra | Aquacel Ag+ Extra | Kerracel Ag | Significant Differences / Justification for Equivalence | | Manufacturer | SFM Ltd | SFM Ltd | Convatec Inc | Convatec Inc | Crawford…