Direct comparison
PluroGel vs Hydrogel: FDA Class and Differences
PluroGel vs hydrogel dressings: FDA product codes FRO and NAE, 510(k) K233151, cleared Rx and OTC indications, and what to request from a supplier.
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How do PluroGel (510(k) K233151), Hydrogel wound dressing (21 CFR 878.4022) compare side by side?
The table below compares PluroGel (510(k) K233151), Hydrogel wound dressing (21 CFR 878.4022) across 12 procurement-relevant dimensions, from what the record says it is through source.
Side-by-side comparison
| Dimension | PluroGel (510(k) K233151) | Hydrogel wound dressing (21 CFR 878.4022) |
|---|---|---|
| What the record says it is | A "translucent, biocompatible, odorless, semisolid gel" that "contains a surfactant, and is water soluble to aid in the removal of wound debris in between dressing changes" (K233151 summary). | A device "intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination" (21 CFR 878.4022(a)). |
| Defining material | Ingredients listed in the 510(k) summary: poloxamer, purified water, phenoxyethanol, sodium phosphate dibasic, potassium sorbate, citric acid. | A nonresorbable matrix of hydrophilic polymers or other material combined with water (at least 50 percent) and capable of absorbing exudate. |
| FDA product code and class | Product code FRO, "Dressing, Wound, Drug"; regulatory class Unclassified (no regulation number in the openFDA classification record). | Product code NAE, "Dressing, Wound, Hydrogel Without Drug And/Or Biologic"; Class I, regulation 878.4022. |
| 510(k) status | K233151, Medline Industries, LP: received 2023-09-27, cleared 2024-03-26 (substantially equivalent) against predicate Sonafine Wound Dressing, K110172. | Class I (general controls); exempt from premarket notification (510(k)) subject to the limitations in 21 CFR 878.9. |
| Stated use (cleared labeling vs regulation) | Rx version: management of full and partial thickness wounds including surgically created wounds, dermal ulcers (pressure ulcers), leg ulcers (diabetic foot ulcers), superficial wounds, first degree burns, partial thickness burns and donor sites; maintains a moist wound and skin environment that supports autolytic debridement of necrotic tissue. OTC version: management of minor cuts, minor burns and minor lacerations. | The regulation describes the device type (cover a wound, absorb exudate, control bleeding or fluid loss, protect). Specific wound indications come from each product's own labeling, not from the regulation. |
| Sterility | Provided non-sterile; a preserved formulation (phenoxyethanol and potassium sorbate inhibit microbial growth within the product). | The regulation covers "a sterile or non-sterile device". |
| Added agents | Two antimicrobial preservative agents are listed in the formulation. The Rx labeling is named "Antimicrobial Burn and Wound Dressing". | The 878.4022 classification does not include a hydrogel dressing with added drugs such as antimicrobial agents, added biologics such as growth factors, or materials derived from animal sources. |
| Exudate absorption | The 510(k) summary makes no exudate-absorption statement; it describes moisture maintenance and water solubility to aid debris removal. | Absorbing exudate is part of the regulatory definition ("capable of absorbing exudate"). |
| Packaging in the cleared record | 50 g jars (the predicate is provided in 28 g, 45 g and 90 g tubes). | Not specified by the regulation. |
| Biocompatibility basis | Categorised as a surface device for breached or compromised skin with prolonged contact (more than 24 hours to 30 days), evaluated under ISO 10993-1 and FDA guidance; period-of-use testing supports preservative effectiveness. | Not specified by the regulation; each product's file addresses it. |
| When the distinction matters | Choose by the labeled indication in the cleared instructions for use of the specific product (Rx or OTC version), not by the word "gel". | Choose by the labeled indication and the product code on the specific product's own listing, not by the word "hydrogel". |
| Source | FDA 510(k) K233151 decision letter and summary (https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233151.pdf), read 2026-11-02; openFDA classification record, product code FRO. | 21 CFR 878.4022 (https://www.law.cornell.edu/cfr/text/21/878.4022) and openFDA classification record, product code NAE (https://api.fda.gov/device/classification.json?search=product_code:NAE), read 2026-11-02. |
Common questions
Common questions about PluroGel (510(k) K233151) vs Hydrogel wound dressing (21 CFR 878.4022)
Is PluroGel a hydrogel?
+
FDA lists PluroGel (K233151) under product code FRO, "Dressing, Wound, Drug", class Unclassified, as a poloxamer and water semisolid gel with a surfactant. The hydrogel wound dressing regulation, 21 CFR 878.4022, defines the category as a hydrophilic polymer matrix with at least 50 percent water that can absorb exudate, listed under product code NAE. The records classify them separately; they do not rate one above the other.
What FDA product code does PluroGel have?
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FRO, "Dressing, Wound, Drug", regulatory class Unclassified, per 510(k) K233151 (cleared 2024-03-26) and the openFDA classification record.
Is a hydrogel dressing exempt from 510(k)?
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A hydrogel wound dressing without added drugs, biologics or animal-derived materials is Class I under 21 CFR 878.4022 and exempt from premarket notification, subject to the limitations in 21 CFR 878.9. A dressing outside that description, such as one cleared under another product code, is assessed on its own record.
Going deeper
