Direct comparison
Xeroform vs Vaseline Gauze: FDA Labeling Compared
Xeroform vs vaseline (petrolatum) gauze: how FDA records word composition, product code, class and use, and where to look up each product record.
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How do Xeroform petrolatum gauze and Plain petrolatum (vaseline) gauze compare side by side?
The table below compares Xeroform petrolatum gauze and Plain petrolatum (vaseline) gauze across 9 dimensions, from composition as worded in the records to when to match each name to a product.
Side-by-side comparison
| Dimension | Xeroform petrolatum gauze | Plain petrolatum (vaseline) gauze |
|---|---|---|
| Composition as worded in the records | Absorbent gauze impregnated with Xeroform in a petrolatum blend (Kendall Xeroform Petrolatum Dressing, 510(k) K973507). Current AccessGUDID listing: fine mesh gauze impregnated with 3% bismuth tribromophenate in a petrolatum blend. | Absorbent gauze impregnated with white petrolatum (Kendall Curity Petrolatum Gauze Dressing, 510(k) K973511). |
| Added ingredient beyond petrolatum | Bismuth tribromophenate (3% on the AccessGUDID listing reviewed). | None named in the clearance summary; petrolatum is the impregnating material. |
| Form and sterility | Sterile, single-use dressing (K973507); AccessGUDID: packaged sterile, single-use. | Sterile, single-use dressing (K973511). |
| FDA product code on the clearances reviewed | FRO ("Dressing, Wound, Drug"), decision date 12/15/1997. | FRO ("Dressing, Wound, Drug"), decision date 12/16/1997. |
| Device class on the clearances reviewed | Unclassified (Class U in FDA data). | Unclassified (Class U in FDA data). |
| Intended-use wording in the clearance summary | Primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. | Primary contact layer in dressing wounds such as minor burns, skin grafts and skin donor sites; initial layer in surgical dressings; protective layer for injured body sites; seal around tubes and drains leading from the body. |
| Product code on a current device listing | AccessGUDID listing for Xeroform Petrolatum (Derma Sciences Canada) shows product code GER and GMDN term 48132 "Petrolatum woven gauze pad"; prescription use: yes, over the counter: no. | Not a separate record in this comparison; the 1997 clearance code is FRO, so confirm the code on the specific product listing in hand. |
| Where to look up the product record | FDA 510(k) database by K number; NLM AccessGUDID by device identifier. | FDA 510(k) database by K number; NLM AccessGUDID by device identifier. |
| When to match each name to a product | Use "Xeroform" or "bismuth tribromophenate gauze" when the product labeling names bismuth tribromophenate as an ingredient. | Use "petrolatum gauze" or "vaseline gauze" when the product labeling names white petrolatum only. Which product is appropriate for a patient is a clinician decision, not covered here. |
Sources
- FDA 510(k) database K973507 (read 2026-11-01)
- NLM AccessGUDID device 10381780471325 (read 2026-11-01)
- openFDA classification record for product code FRO (read 2026-11-01)
- FDA 510(k) summary K973511 as reproduced at fda.innolitics.com/device/K973511 (read 2026-11-01)
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Common questions
Common questions about Xeroform petrolatum gauze vs Plain petrolatum (vaseline) gauze
What is the difference between Xeroform and vaseline gauze?
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In the records reviewed, Xeroform gauze is gauze impregnated with bismuth tribromophenate in a petrolatum blend, while plain vaseline (petrolatum) gauze is gauze impregnated with white petrolatum. Both 1997 FDA clearances reviewed are sterile, single-use, non-adherent dressings under product code FRO.
What is a petrolatum gauze dressing?
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The FDA clearance summary for Kendall Curity Petrolatum Gauze Dressing (K973511) describes it as a sterile, single-use, non-adherent dressing of absorbent gauze impregnated with white petrolatum. The GMDN term used on AccessGUDID, "Petrolatum woven gauze pad", describes woven material impregnated with petrolatum to increase its nonadherent properties.
Is Xeroform gauze the same as petrolatum gauze?
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Not by composition. Xeroform adds bismuth tribromophenate (3% on the AccessGUDID listing reviewed) to the petrolatum blend. Both belong to the petrolatum gauze family and both 1997 clearances reviewed use FDA product code FRO.
Does FDA classify these dressings?
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The two 1997 clearances reviewed (K973507 and K973511) are listed under product code FRO, "Dressing, Wound, Drug", with device class Unclassified in FDA data. A current AccessGUDID listing for a Xeroform product shows product code GER and prescription-use status, so the code and status depend on the specific product record.
Which one should be used on a wound?
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That is a clinical decision and this page does not give medical advice. Ask the treating clinician or follow the product instructions for use.
Going deeper
