← Product Code [NAD](/submissions/SU/subpart-e%E2%80%94surgical-devices/NAD) · K955863 # ALLDRESS MULTI LAYERED WOUND DRESSING (K955863) _Molnlycke/Scott Health Care · NAD · Mar 13, 1996 · General, Plastic Surgery · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAD/K955863 ## Device Facts - **Applicant:** Molnlycke/Scott Health Care - **Product Code:** [NAD](/submissions/SU/subpart-e%E2%80%94surgical-devices/NAD.md) - **Decision Date:** Mar 13, 1996 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4020 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use For the dressing and management of chronic/open wounds. ## Device Story Sterile multi-layered wound dressing; absorbent layer with non-adherent contact surface; adhesive backing layer secures dressing to skin. Used in clinical settings for wound management. Modified version of predicate; improved backing layer composition enhances wound barrier properties. Applied by clinicians to cover wounds; provides barrier against bacteria and viruses. Benefits patient by protecting wound site and managing exudate. ## Clinical Evidence Bench testing only. Biocompatibility: intracutaneous toxicity, systemic toxicity, muscle implantation, primary skin irritation, hemolysis, cytotoxicity, and delayed hypersensitivity. Performance: bacterial strike-through (S. aureus, P. aeruginosa) and viral penetration (phiX174 bacteriophage) testing conducted. ## Technological Characteristics Multi-layered sterile dressing; absorbent layer; adhesive backing layer. Dimensions: 2.25"x2.25", 4"x4", 6"x6", 6"x8". Scored siliconized release paper. Barrier performance validated via ASTM viral penetration testing. ## 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 - AllDress® Multi Layered Wound Dressing ([K945206](/device/K945206.md)) ## Reference Devices - Comfeel® Plus Ulcer Dressing ([K941263](/device/K941263.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} MAR 13 1996 510 (k) SUMMARY K955863 # 1. ADMINISTRATIVE Submitter: Mölnlycke/Scott Health Care 500 Baldwin Tower Eddystone, PA 19022 Contact Person: Mike Drummond (610) 499-3375 Date of Preparation: December 26, 1995 # II. DEVICE NAME Proprietary Name: AllDress® Common Name: Sterile Multi-Layered Wound Dressing Classification Name: Wound Dressing Regulatory Class: Unclassified Product Code: 79FRO # III. PREDICATE DEVICE AllDress® Multi Layered Wound Dressing (Scott Health Care; K945206) # IV. DEVICE DESCRIPTION The AllDress® Multi Layered Wound Dressing is a sterile wound dressing composed of an absorbent layer with a non-adherent wound contact surface. The absorbent layer is bonded to an adhesive backing layer which secures the dressing to the skin around the wound. Dressings are supplied in sizes of 2¼" x 2¼" (1" x 1" wound contact surface); 6" x 6" (4" x 4" wound contact surface); 4" x 4" (2" x 2" wound contact surface); and 6" x 8" (4" x 6" wound contact surface). The wound contact side of the dressing is covered with scored siliconized release paper to permit aseptic application. The AllDress® Multi Layered Wound Dressing represents a modified version of the currently marketed AllDress® Multi Layered Wound Dressing (K945206) and is identical to the predicate device with respect to function and intended use. to the Comfeel® Plus Ulcer Dressing (K941263). The composition of the backing layer of the modified product has been changed to improve the wound barrier properties of the dressing. Biocompatibility of the modified device has been established by intracutaneous toxicity test (rabbit), systemic toxicity test (mice), muscle implantation test (rabbit), primary skin irritation test (rabbit), hemolysis test (In Vitro), cytotoxicity test (In Vitro), and delayed hypersensitivity test (guinea pig). In addition, bacterial penetration (strike-through) studies with S. aureus and P. aeruginosa and ASTM Premarket Notification: AllDress Multi-Layered Wound Dressing (modified) 11 {1} IV. DEVICE DESCRIPTION (continued) viral penetration test with $\phi X174$ bacteriophage were conducted to demonstrate the effective performance of the dressing as a bacterial and viral barrier. V. INTENDED USE For the dressing and management of chronic/open wounds. VI. CONCLUSION The technological characteristics of the modified AllDress™ Multi Layered Wound Dressing are the same as to those of the predicate device, except for compositional changes intended to improve its wound barrier properties of the product. Biocompatibility and performance testing of the modified device have demonstrated safety as well as effective wound barrier performance. Accordingly, Mölnlycke/Scott Health Care has concluded that the modified device is safe and effective for its intended use and performs at least as well as the legally marketed predicate device. Premarket Notification: AllDress Multi Layered Wound Dressing (modified) 12 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAD/K955863](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAD/K955863) **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