Who is the manufacturer of Medline Burn and Wound Dressing?

Medline Industries, Inc. filed the 510(k) submission for Medline Burn and Wound Dressing (K173911).

What is the FDA product code for Medline Burn and Wound Dressing?

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

What is the regulatory pathway for Medline Burn and Wound Dressing?

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

What are the predicate devices for Medline Burn and Wound Dressing?

Prontosan Wound Gel (K101882); Manuka Fill (K131796).

Who can help prepare an FDA 510(k) submission like Medline Burn and Wound Dressing?

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.

Medline Burn and Wound Dressing

K173911 · Medline Industries, Inc. · FRO · Jul 19, 2018 · SU

Device Facts

Record ID	K173911
Device Name	Medline Burn and Wound Dressing
Applicant	Medline Industries, Inc.
Product Code	FRO · SU
Decision Date	Jul 19, 2018
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

Medline Burn and Wound Dressing is intended to cleanse and moisten the wound bed and for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used to provide a moist environment that supports autolytic debridement of necrotic tissue.

Device Story

Translucent, odorless, semisolid gel; contains surfactant and polyhexanide (PHMB) preservative. Applied to wound bed to cleanse, moisten, and protect against desiccation; supports autolytic debridement. Used in clinical settings by healthcare professionals; provided non-sterile for single-patient, multiple-use. Water-soluble formulation aids debris removal during dressing changes. Benefits include optimal moist healing environment and reduced mechanical trauma during cleansing.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993-1), shelf-life testing, USP <51> antimicrobial effectiveness testing, and a GLP-compliant animal wound healing study.

Technological Characteristics

Semisolid, water-soluble gel. Ingredients: Poloxamer, Purified Water, Glycerin, Sucrose, Sodium Phosphate Dibasic, Citric Acid, PHMB (preservative). Non-sterile, single-patient, multiple-use configuration. No electronic components or software.

Indications for Use

Indicated for management of ulcers (diabetic foot, leg, pressure), 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions in patients requiring wound cleansing and moist environment maintenance for autolytic debridement.

Predicate Devices

Prontosan Wound Gel (K101882)
Manuka Fill (K131796)

Related Devices

K223259 — coactiv+ Antimicrobial Wound Gel · Kane Biotech, Inc. · May 24, 2023
K252028 — LUOFUCON® Antimicrobial Wound Gel · Huizhou Foryou Medical Co., Ltd. · Mar 11, 2026
K233151 — PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) · Medline Industries, LP · Mar 26, 2024
K190224 — Medline Burn and Wound Dressing (OTC) · Medline Industries, Inc. · Mar 8, 2019
K192527 — Rochal Antimicrobial Wound Gel · Rochal Industries, LLC · Feb 7, 2020

Submission Summary (Full Text)

{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" followed by the words "U.S. FOOD & DRUG ADMINISTRATION". July 19, 2018 Medline Industries, Inc. Bethany Benoit-DiMaria Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093 Re: K173911 Trade/Device Name: Medline Burn and Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 13, 2018 Received: June 14, 2018 Dear Bethany Benoit-DiMaria: 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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov {1}------------------------------------------------ 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # David Krause -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K173911 Device Name Medline Burn and Wound Dressing #### Indications for Use (Describe) Medline Burn and Wound Dressing is intended to cleanse and moisten the wound bed and for the management of ulcers (including diabetic foot and leg ulcers), 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used to provide a moist environment that supports autolytic debridement of necrotic tissue. | 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image features the Medline logo, which is set against a blue square. The word "MEDLINE" is prominently displayed in white, sans-serif font. A white, stylized starburst symbol is positioned to the right of the text, adding a visual element to the logo. A gray bar is visible on the right side of the image. Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093 ## K173911 510(k) Summary [AS REQUIRED BY 21CFR807.92(c)] ### Submitter / 510(k) Sponsor Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592 ## Contact Person Bethany Benoit-DiMaria Senior Regulatory Affairs Specialist Phone: 847-643-3256 Email: BBenoit-Dimaria@medline.com Summary Preparation Date December 21, 2017 Type of 510(k) Submission Traditional ### Device Name / Classification Name of Device: Medline Burn and Wound Dressing Proprietary Name: Medline Burn and Wound Dressing Common Name: Wound Cleanser, Wound Dressing Classification Name: Dressing, Wound, Drug Product Code: FRO Classification Panel: General & Plastic Surgery Regulatory Class: Unclassified Primary Predicate Device Prontosan Wound Gel K101882 Secondary Predicate Device Manuka Fill K131796 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in bold, sans-serif font, stacked on top of a white star-like shape. The star shape has four points, resembling a compass rose. ledline Industries. Inc hree Lakes Drive ### Device Description Medline Burn and Wound Dressing is a translucent, biocompatible, odorless, semisolid gel intended to cleanse and moisten the wound bed. The dressing maintains moisture in the wound and protects the wound from dessication to provide an optimal moist wound environment conducive to wound healing. Medline Burn and Wound Dressing contains a gentle surfactant and is water soluble to aid in the removal of wound debris in between dressing changes. Medline Burn and Wound Dressing is provided non-sterile for single patient use. Polyhexanide (PHMB) acts as a preservative to inhibit the growth of microorganisms within the product. #### Indications for Use For Prescription Use: Medline Burn and Wound Dressing is intended to cleanse and moisten the wound bed and for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used to provide a moist environment that supports autolytic debridement of necrotic tissue. ### Summary of Technological Characteristics Medline Burn and Wound Dressing was developed for the management of wounds that benefit from a moist wound environment and cleansing without unnecessary mechanical trauma. Polyhexanide (PHMB) acts as a preservative to inhibit the growth of microorganisms within the product. | DEVICE CHARACTERISTIC | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | SECONDARY PREDICATE DEVICE | COMPARISON ANALYSIS | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | Product Name | Medline Burn and Wound Dressing | Prontosan Wound Gel | Manuka Fill | N/A | | 510(k) Reference | K173911 | K101882 | K131796 | N/A | | Product Code | FRO | FRO | FRO | Same as Primary Predicate (K101882) Same as Secondary Predicate (K131796) | | Intended Use | Professional Use: Medline Burn and Wound Dressing is intended to cleanse and moisten the | Professional Use: Prontosan Wound Gel is intended to cleanse and moisten the wound bed and | Under the supervision of a healthcare professional, Manuka Fill wound dressing is | Same as Primary Predicate | | | wound bed and for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used to provide a moist environment that supports autolytic debridement of necrotic tissue. | for the management of ulcers, 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used during wound dressing changes to soften encrusted wound dressings. | indicated for the management of: Leg Ulcers, Pressure Ulcers, 1st and 2nd Degree Burns, Diabetic Foot Ulcers, Surgical Wounds, Trauma Wounds. Manuka Fill wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue | (K101882) Same as Secondary Predicate (K131796) | | Regulation Number | Unclassified | Unclassified | Unclassified | Same as Primary Predicate (K101882) Same as Secondary Predicate (K131796) | | Configurations | 1.75 oz tube | 30 ml tube | Individual tubes in a variety of sizes | Similar to Primary Predicate (K101882) Similar to Secondary Predicate (K131796) | | Design Features | Clear to translucent, water soluble, virtually odorless, amorphous wound gel with a surfactant and PHMB as a preservative | Clear, colorless, and virtually odorless aqueous wound gel with a surfactant and PHMB as a preservative | Wound gel with honey, helps maintain a moist wound environment conducive to wound healing | Similar to Primary Predicate (K101882) Similar to Secondary Predicate (K131796) | | Materials | Poloxamer, Purified Water, Glycerin, Sucrose, Sodium Phosphate Dibasic, Citric Acid, PHMB | Purified Water, Glycerol, Hydroxyethylcellulose, Undecylenamidopropyl Betaine, PHMB | 100% Leptospermum scoparium honey from New Zealand | Similar to Primary Predicate (K101882) | | | | | | Secondary Predicate (K131796) | | Non-Clinical Testing | -Biocompatibility in accordance to 10993-1 -Shelf Life -USP<51>Antimicrobial Effectiveness -Wound Healing Study | -Biocompatiblity in accordance to 10993-1 (breached or compromised surfaces with prolonged contact (>24h to 30d) -Shelf Life -USP<51>Antimicrobial Effectiveness -USP<85> Bacterial Endotoxin Testing | -Biocompatibility in accordance to 10993-1 (breached or compromised surfaces with prolonged contact (>24h to 30d) -Sterilization Validation -Packaging Validation -Shelf Life -Wound Healing Study | Similar to Primary Predicate (K101882) Similar to Secondary Predicate (K131796) | | Sterile vs. Non- Sterile | Non-sterile | Sterile by aseptic filtration until first opened | Sterile by gamma irradiation | Different than Primary Predicate (K101882) Different than Secondary Predicate (K131796) | | Reusable vs. Single Use | Single patient, multiple use | Single patient, multiple use | Single use | Same as Primary Predicate (K101882) Similar to Secondary Predicate (K131796) | #### Proposed and Predicate Device(s) Comparison {5}------------------------------------------------ Image /page/5/Picture/0 description: The image features the Medline logo, which is set against a blue square background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a white, stylized starburst or cross-like symbol. The starburst is vertically oriented, with its pointed ends extending upwards and downwards from the word "MEDLINE." Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Medline logo. The logo is white text on a blue background. The text "MEDLINE" is in a sans-serif font. There is a white starburst-like shape to the right of the text. Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093 ### Summary of Non-Clinical Testing Medline Burn and Wound Dressing and the predicate device have the same intended use, and similar technological characteristics that do not raise different questions of safety and effectiveness. In order to address the same questions of safety and effectiveness and demonstrate that the differences in technological characteristics do not introduce new issues of safety and effectiveness, biocompatibility testing in accordance to ISO 10993-1, shelf-life testing to finished product specifications, and nonclinical performance testing (animal wound healing study) were conducted in accordance with GLP (21 CFR 58). Summary of Clinical Testing Not applicable. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked vertically, with a white starburst symbol to the right of the text. The background is a solid dark blue color. There is a gray bar on the right side of the image. Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 #### Conclusion In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Burn and Wound Dressing is as safe and as effective for its intended use as the predicate devices [Prontosan Wound Gel (K101882) and Manuka Fill (K131796)].