← Product Code [KMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF) · K961452 # LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING (K961452) _Acme United Corp. · KMF · May 31, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF/K961452 ## Device Facts - **Applicant:** Acme United Corp. - **Product Code:** [KMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF.md) - **Decision Date:** May 31, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5090 - **Device Class:** Class 1 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is intended for the treatment of moderately to heavily exuding wounds while the Modified Lyofoam® Wound Dressing would be used to treat lightly to moderately exuding, wounds. Lyofoam® Extra "A" provides a waterproof barrier for the wound which is moisture vapor permeable and helps to prevent bacterial contamination of the wound. ## Device Story Lyofoam® Extra "A" is a sterile, adhesive, polyurethane foam island dressing; combines extra-absorbent foam pad with adhesive border. Device functions as a waterproof, moisture vapor permeable barrier to prevent bacterial contamination; absorbs excess wound fluid. Used in clinical or home settings for wound management. Healthcare providers apply dressing over wound; adhesive border secures device in place. Benefits include enhanced fluid management for heavily exuding wounds and protection against external contaminants. ## Clinical Evidence No clinical data. Performance and safety data rely on previously submitted files K952565 and K895764. ## Technological Characteristics Polyurethane foam island dressing; adhesive border; waterproof and moisture vapor permeable; sterilized via gamma radiation (SAL 10⁻⁶); packaged in paper/foil peel pouch. ## Regulatory Identification A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. ## Predicate Devices - Modified Lyofoam® Wound Dressing ([K895764](/device/K895764.md)) - Lyofoam® Extra Absorbent Wound Dressing ([K952565](/device/K952565.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} Page 12 K961452 Page 1 of 3 Acme United Corporation MAY 31 1996 510(K) SUMMARY Submitter's Name: Acme United Corporation 75 Kings Highway Cutoff Fairfield, CT 06430 Contact Person: Thomas E. Flynn, Director of Regulatory Affairs and Quality Assurance Telephone Number: 203-332-7330 Fax Number: 203-576-0007 Date of Submission: "This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92." The assigned 510(K) number is: Proprietary Name of Device: Lyofoam® Extra "A" Sterile Adhesive Wound Dressing Common/Usual Name: Extra absorbent, polyurethane foam island dressing. Classification Name: Dressing, Class I Product Claiming Equivalence To: Modified Lyofoam® Wound Dressing and Lyofoam® Extra Absorbent Wound Dressing Description of Device: Lyofoam® Extra "A", Extra Absorbent, Non-Adherent Polyurethane Foam Dressing with adhesive boarder. ) Medical Products Division • 75 Kings Highway Cutoff, Fairfield, Connecticut 06430 • Phone (203) 332-7330 {1} Page 13 K961452 Page 2 of 3 # Acme United Corporation Intended Use, Comparison To Predicate Device: The Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is a combination of the Lyofoam® Extra product and the Modified Lyofoam® Dressing Product (Lyofoam® "A"). The main difference between them is that Lyofoam® Extra Foam Dressing is used in place of the regular Lyofoam® for the wound dressing pad segment of this product. The third layer of thin foam is extended beyond the wound pad and has a adhesive coating which is used to hold the product in place over the wound. The inner absorbent layer of Lyofoam® Extra Wound Dressing Pad holds more excess wound fluid than the Modified Lyofoam® Wound Dressing Pad which is made from regular Lyofoam®. The Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is intended for the treatment of moderately to heavily exuding wounds while the Modified Lyofoam® Wound Dressing would be used to treat lightly to moderately exuding, wounds. Lyofoam® Extra "A" provides a waterproof barrier for the wound which is moisture vapor permeable and helps to prevent bacterial contamination of the wound. Medical Products Division • 75 Kings Highway Cutoff, Fairfield, Connecticut 06430 • Phone (203) 332-7330 {2} Page 14 K961452 Page 3 of 3 Acme United Corporation Performance data for this product can be found in the Lyofoam® Extra 510(K) File K952565. Safety: Safety test data can be found in both the Lyofoam® Extra 510(K) file K952565 and Modified Lyofoam® Dressing file; K895764. All safety data is summarized in those files and indicates product is safe for use. Sterility and Packaging: Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is packaged in a paper/foil peel pouch and is sterilized using gamma radiation and has a SAL 10⁻⁶. Medical Products Division • 75 Kings Highway Cutoff, Fairfield, Connecticut 06430 • Phone (203) 332-7330 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF/K961452](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF/K961452) **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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