Wound Care & NPWT Materials

The standard wound-interface material is an ISO 10993-referenced reticulated open-cell polyurethane. Its through-porous cell structure lets fluid move through it and, under negative pressure, lets that pressure distribute across the foam so it is spread across the contact area rather than concentrated at a point. That is a material job: the open-cell pore grade is what tunes how fluid and pressure move, so the same reticulated polyurethane is supplied across a pore-grade range and you state the grade or the target behavior for your design.

H-O the foam to the dressing footprint with clean converted edges that do not shed. The grade is referenced to ISO 10993 by designation for the breached-surface contact, evaluated by the material maker, and the foam is characterized per ASTM D3574. This is a fluid-management and pressure-distribution material; H-O makes no clinical claim and the device maker owns the finished-device file.

They do opposite jobs. An open-cell, through-porous foam (reticulated polyurethane) lets fluid and pressure move through it, so it is the choice for the wound-interface and wicking layers where fluid and (in NPWT) pressure need to distribute across the foam. A closed-cell or microcellular foam (crosslinked polyethylene, PORON Medical) does not move fluid through it but carries load and cushions, so it is the choice for the support and pressure-offloading pad.

Using a closed-cell foam at the interface means fluid and pressure will not distribute; using an open-cell foam in an offloading pad means it will collapse under load. Decide the layer first, then the cell structure follows. The dressing usually combines both, and H-O converts the layers in the order the drawing calls for. Foam properties for both are characterized per ASTM D3574.

The open-cell pore grade is the controlling property of a reticulated polyurethane wound foam. A more open, coarser pore moves fluid and distributes pressure quickly through the foam; a finer pore wicks more slowly and tends to hold more fluid. Reticulated polyurethane is supplied across a pore-grade range for exactly this reason, so the foam name alone does not fully specify the part.

State the fluid job, the volume and rate the layer is designed for, and the pore grade or the target behavior, and H-O converts the grade your drawing calls for. The pore grade and absorbency are material properties per the maker TDS, and this page frames them qualitatively rather than quoting numbers that vary by grade. Foam properties are characterized per ASTM D3574.

The dressing performance against the pore grade is the device maker's to validate.

Bottoming out means the foam compresses fully under load so pressure is no longer redistributed. The usual cause is the wrong foam: a soft, low-density single layer compresses all the way and loses its cushion. The fix is a stack that carries the load: a soft microcellular polyurethane such as PORON Medical on the comfort side, over a firmer crosslinked polyethylene that resists bottoming out, and laminated together.

Match the firmness and the stack thickness to the load and the offloading geometry. A low-compression-set microcellular polyurethane also holds its loft over wear rather than flattening. Firmness, force-deflection, and compression set are material properties per the maker TDS, characterized per ASTM D3574. State the load and the wear duration so the grade and the stack match the life; the offloading performance is the device maker's to validate.

An open-cell foam can leave loose particles or a ragged edge if the cut method or the material grade is not matched to it. A clean converted edge is a converting-side requirement, and H-O selects the cutting method and tooling for the open-cell grade, die-cutting, kiss-cutting, laser-cutting, or waterjet-cutting the reticulated polyurethane so the edge is clean and does not shed loose particles into the dressing stack.

State the edge requirement on the drawing so the right method is chosen. The edge quality is something H-O owns as the converter; the device maker validates the finished dressing for particulate. Foam properties that affect the cut are characterized per ASTM D3574, and grade-specific behavior is per the maker TDS.

H-O references material grades by designation and assembles documentation aligned to your requirements. A wound-contact foam is often a breached-surface contact, which is more stringent than intact-skin contact, so state the contact type, the duration, and the basis you need, ISO 10993 endpoints (for example cytotoxicity, sensitization, irritation), a USP Class VI designation, or an FDA contact basis, and H-O sources a grade whose maker evaluates it against those frameworks and provides the material TDS, certificate of conformance, and lot traceability.

The important distinction is who owns what: the material maker evaluates the grade at the material level, and the device maker owns the finished-device biocompatibility, the clinical evaluation, and the regulatory file. H-O is an ISO 9001:2015 certified converter; it does not independently certify materials, does not make clinical claims, and does not claim an ISO 13485 certification, an FDA device registration, or a cleanroom certification.

Customer-specified compliance packages are assembled on request.

Most wound-care and NPWT materials are single-use and are sterilized as part of the finished dressing or kit, commonly by ethylene oxide, gamma, or e-beam. The method matters to the material: polyethylene tolerates a high radiation dose, while reticulated polyurethane behavior under sterilization is method- and grade-dependent, and any radiation dose limit is a maker-TDS property to verify for the grade.

State the sterilization method and whether the part is single-use on the drawing, because that sets which grade and construction is chosen and how the part is packaged and converted. H-O converts the material and supplies the documentation; the sterilization validation of the finished device, and the choice and qualification of the sterilization cycle, belong to the device maker. This is a material-level consideration, not a device-level claim.

Yes. A dressing is a stack, and H-O converts the parts: the interface or absorbent foam, the drape film to the seal outline with its port or boss feature, and the skin-side adhesive border, laminated and kiss-cut on a release liner so the line can peel and place it. The skin-contact adhesive (a silicone, acrylic, or hydrocolloid type) is referenced to the relevant ISO 10993 parts, especially sensitization (-10) and irritation (-23), at the material level when specified, the same way the foam is referenced for its contact.

State the layer order, which face carries the adhesive, the drape film, and whether the part ships kiss-cut on liner. H-O laminates the stack, the parts, and kiss-cuts on liner to your drawing. The adhesive family is named only when it is catalog-verified; otherwise it is framed qualitatively and selected with you.

They are the two sides of an offloading stack and are usually used together rather than one instead of the other. PORON Medical is a microcellular polyurethane with controlled soft force-deflection and low compression set, so it is the soft comfort side that conforms gently and holds its loft over wear. Crosslinked polyethylene is a firm, fine-celled closed-cell foam that carries the load and resists bottoming out, so it is the firm base.

The common construction is a soft PORON Medical layer over a firmer crosslinked PE base, and laminated, so the pad is comfortable on the skin side and does not bottom out under load. If you need a single material, choose PORON Medical for a comfort-led light-load pad and crosslinked PE for a firm, durable, higher-load pad. Firmness and compression set are material properties per the maker TDS, characterized per ASTM D3574; the offloading performance is the device maker's to validate.

No. H-O Products is a precision converter of materials. It makes the foam, drape, and adhesive parts that wound-care dressings and NPWT kits are built from, framed as fluid-management, pressure-distribution, and cushioning materials. H-O makes no claim about wound healing, therapy outcomes, clinical efficacy, or treatment, and nothing on this page should be read as a clinical claim.

The clinical performance, the indications for use, the finished-device biocompatibility and clinical evaluation, the sterilization validation, and the regulatory file all belong to the device maker.

H-O references the material grades by designation to ISO 10993, USP Class VI, and FDA contact frameworks at the material level, where the material maker performs the evaluation, and supplies the converted parts, the material documentation, and lot traceability aligned to your requirements, as an ISO 9001:2015 certified organization.

No. H-O Products is a precision converter: it makes the wound-care and NPWT material parts (interface foams, wicking layers, offloading pads, drape films, adhesive borders) to your drawing from material grades commonly used in wound-care constructions, under an ISO 9001:2015 quality management system. H-O is an ISO 9001:2015 certified organization; that certification governs the converting process, not a device clearance.

H-O does not make finished medical devices and does not claim an ISO 13485 certification, an FDA device registration or clearance, or a cleanroom certification.

Material grades are referenced by designation to ISO 10993, USP Class VI, and FDA contact frameworks at the material level, where the material maker performs the evaluation. The finished-device file, the clinical claims, and the regulatory submissions belong to the device maker. H-O supplies the converted parts, the material documentation, and lot traceability aligned to your requirements.

Send the dressing or kit drawing or a sample, the layer, and four things: the layer and job (wound interface, wicking, offloading, or drape/port seal), the contact basis (intact skin, breached or compromised surface, or no contact, and the duration), the fluid or load job (distribute fluid or pressure, absorb or wick, cushion or offload) with the pore grade or firmness if known, and the sterilization method and whether the part is single-use.

If you need a biological basis documented, state the ISO 10993 endpoints, the USP Class VI designation, or the FDA contact basis. Add the geometry, the gauge or stack thickness, the edge requirement, the adhesive and drape construction, and prototype and annual volume. With that, engineering returns a material family, a converted-part approach, prototype lead time, and the documentation that can be aligned to your requirements.

The quote form below has fields for each of these. Samples typically ship in 3 to 5 business days; standard production in about 2 weeks.