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For the local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds.

The Dermaplex Hydrogel Wound Dressing consists of a 12-ply cotton gauze pad dressing impregnated with a clear, viscous hydrogel. The product is available in four sizes (2" x 2", 4" x 4", 4" x 8" and 6" x 10") and is supplied sterile in sealed aluminum/plastic laminate pouches.

This 510(k) summary (K962439) for the Dermaplex Hydrogel Wound Dressing does not contain any information about acceptance criteria, device performance metrics, or a study proving the device meets specific criteria related to clinical effectiveness or diagnostic accuracy.

The summary focuses on:

• Administrative details: Submitter, contact, date, device name.
• Device description: Composition, sizes, sterility, and biocompatibility testing (which is a safety assessment, not a performance study in the context of clinical outcomes).
• Intended use: The types of wounds the dressing is meant to treat.
• Comparison to predicate device: Stating similarity in composition, function, and intended use to a previously cleared device (MPM GelPad). This is the basis for claiming substantial equivalence, implying it is "as safe and effective" as the predicate.

Therefore, I cannot provide the requested information, particularly items 1 through 9, because the provided text does not include any clinical study data or performance metrics for the Dermaplex Hydrogel Wound Dressing itself, beyond biocompatibility tests. The device's claim of safety and effectiveness is based on its similarity to a predicate device, not on a new study demonstrating specific performance criteria.

To answer your questions, such information would need to be present, detailing a study that measured outcomes for the Dermaplex Hydrogel Wound Dressing against defined acceptance criteria.

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