Redermax Antibacterial Wound Matrix

Redermax Antibacterial Wound Matrix is a sterile, absorbable wound matrix made of electrospun composite fibers (PLGA and PDO with Poloxamer 188 and PHMB) supplied as a soft, white sheet. It is intended for management of various wound types including pressure ulcers, venous ulcers, diabetic ulcers, surgical wounds, trauma wounds, and draining wounds. The device provides a healing environment and degrades completely within approximately 28 days.

Redermax uses electrospun composite fibers of PLGA and PDO with Poloxamer 188 and 2.5 wt% PHMB, whereas the predicate uses animal-derived collagen coated with PHMB at lower concentration. Both are biodegradable, absorbable matrices with comparable resorbability profiles, antimicrobial function, mechanical performance, absorbency, and biocompatibility. Redermax is sterilized via E-beam and demonstrates tensile strength >4.1 N and complete degradation within 28 days.

ISO 13485 (Design controls, nonconforming product, corrective and preventative action), ISO 10993 (Biocompatibility), ISO 10993-18 (Heavy metal content), ISO 11137-2 (E-beam sterilization), AATCC 100 (Antibacterial performance testing), and 21 CFR Parts 820, 801, 803, 807, 830.

Redermax is substantially equivalent to PuraPly® Antimicrobial Wound Matrix (K051647) because both are absorbable wound matrices with the same intended use for wound management. Despite differences in material composition (synthetic vs. collagen-derived), both devices demonstrate comparable safety and performance characteristics including biodegradability, antimicrobial function via PHMB, mechanical performance, and biocompatibility. Non-clinical testing confirms performance comparable to the predicate without raising different safety or effectiveness questions.