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Xeroform Gauze: Types, Sizes and FDA Standards

A comprehensive guide to Xeroform gauze dressings, covering 3% bismuth tribromophenate formulation, sizes, FDA regulatory limits, and handling guidelines.

Written and maintained by CASRAI Editorial Board

Published · Last updated

This page describes products and general use; it is not medical advice.

On this page

Who uses it: Clinical staff, surgical teams, wound care specialists, and medical supply buyers managing non-adherent primary wound contact layers.

What it is

Xeroform gauze is a sterile, non-adherent primary wound contact dressing consisting of fine-mesh absorbent gauze saturated with a petrolatum blend containing 3% bismuth tribromophenate. Its clinical purpose is to provide a soothing, moisture-retentive contact layer that protects exposed tissue beds, prevents secondary dressing adherence, and reduces wound odor through the mild bacteriostatic action of its bismuth compound.

Under U.S. Food and Drug Administration (FDA) device classifications, Xeroform dressings are categorized primarily under Product Code FRO (“Dressing, Wound, Drug”) as an Unclassified Pre-Amendment device, or under Product Code NAD (“Dressing, Wound, Occlusive”, 21 CFR 878.4020, Class 1). FDA evaluates these products via traditional 510(k) premarket notifications to confirm equivalence in materials, biocompatibility, and clinical indications.

How it works or is built

Xeroform gauze combines a textile substrate with an active impregnating ointment blend:

  • Fine-Mesh Textile Substrate: Finely woven cotton or absorbent gauze mesh prevents granulating tissue from growing into fabric interstices, eliminating trauma during dressing changes.
  • Active Impregnating Blend: USP petrolatum creates a moisture-retentive hydrophobic barrier, while 3% bismuth tribromophenate (CAS 5175-83-7) imparts a characteristic yellow color and provides bacteriostatic deodorization.
  • Sterility Assurance: Manufacturing follows ANSI/AAMI/ISO 11137 standards, using gamma radiation sterilization to achieve a Sterility Assurance Level (SAL) of 10-6. Dressings are sealed in chevron peel pouches.

Types and variants

Authentic Xeroform dressings share the 3% bismuth tribromophenate formulation across four main clinical configurations:

Dressing Variant Carrier Base Typical Clinical Use Key Distinguishing Feature
Occlusive Petrolatum Gauze Fine-mesh woven cotton in petrolatum blend Donor sites, skin grafts, abrasions, minor burns Occlusive moisture barrier; conforms closely to flat beds
Non-Occlusive Oil Emulsion Gauze Knitted cellulose acetate in oil emulsion Surgical incisions and draining wounds Porous weave allows exudate to pass into secondary pads
Packing Strips Narrow woven ribbon (e.g., 1″ × 8″) Nasal packing, fistulas, tunneling wounds High tensile strength prevents tearing during extraction
Continuous Rolls Continuous roll (e.g., 4″ × 9 ft) Extensive burns, circumferential limb wraps Permits rapid coverage without overlapping seams

Clinicians evaluating contact layers frequently consult our Xeroform vs Vaseline gauze comparison to verify if bismuth is required, or review Adaptic and oil emulsion dressings when exudate drainage through knitted fabrics is necessary.

Sizes or specifications that matter

FDA 510(k) clearances (Dynarex K152970, Roosin K181478, Kendall/Cardinal Health K973507) and FDA AccessGUDID records specify standard clinical sizes and HCPCS billing codes:

Format Dimensions Sourced Catalog Numbers CMS HCPCS Code
Square Patch 2″ × 2″ (5.1 cm × 5.1 cm) Dynarex #3051; Cardinal #8884433400; Roosin K181478 A6222 (Impregnated gauze, pad ≤ 16 sq in)
Packing Strip 1″ × 8″ (2.5 cm × 20.3 cm) Dynarex #3052; Cardinal #8884433301; Roosin K181478 A6222 (Impregnated gauze, pad ≤ 16 sq in)
Square Patch 4″ × 4″ (10.2 cm × 10.2 cm) Dynarex #3053; Cardinal #8884433500; Roosin K181478 A6222 (Impregnated gauze, pad ≤ 16 sq in)
Oblong Sheet 5″ × 9″ (12.7 cm × 22.9 cm) Dynarex #3054; Cardinal #8884433605; Roosin K181478 A6223 (Impregnated gauze, pad > 16 to ≤ 48 sq in)
Continuous Roll 4″ × 9 ft (10.2 cm × 2.7 m) Cardinal #8884432000 A6266 (Impregnated gauze, per linear yard)

Cleared dressings are sterile, single-use, and latex-free, maintaining a 3 to 5 year shelf life while peel pouch seals remain intact.

How to choose

Selection should follow manufacturer instructions for use, drainage volume, and wound contours:

  • Exudate Volume: Use occlusive petrolatum gauze for dry to minimally draining wounds and donor sites where moisture retention is desired. Select non-occlusive oil emulsion gauze for draining wounds to allow fluid transfer into secondary absorbent layers.
  • Wound Anatomy: Use 1″ × 8″ strips for narrow tracks, sinus packing, or dry sockets. Select 2″ × 2″ or 4″ × 4″ patches for localized cuts. Use 5″ × 9″ sheets or rolls for circumferential limb wrapping.
  • Patient Sensitivity: Confirm the patient has no hypersensitivity to bismuth or petrolatum. If sensitivities exist, switch to non-medicated non-stick sterile wound dressings or silicone contact layers.
  • Layering Requirements: Recognize the distinction between a primary dressing and a secondary bandage. Xeroform serves strictly as a non-absorbent contact layer and requires secondary absorbent pads and securing wraps.

Safe use and handling basics

Observe standard clinical handling derived from manufacturer IFUs and regulatory clearances:

  • Storage Conditions: Store at 15°C to 30°C (59°F to 86°F). Avoid temperatures above 40°C, which cause petrolatum melting and pouch leakage.
  • Aseptic Application: Inspect the peel pouch before opening; discard if punctured. Using sterile gloves or forceps, drape or pack the dressing smoothly over the wound bed without tension.
  • Secondary Coverage: Cover with sterile secondary absorbent gauze and secure with medical tape or cohesive wraps.
  • Atraumatic Removal: Peel back gently. If dried drainage causes adherence, moisten with sterile saline before lifting.
  • Mandatory FDA 510(k) Limitations: Under FDA clearance terms (e.g., K152970, Section 8), labeling is legally restricted:
    1. Must not be labeled for use on third-degree burns.
    2. Must not be labeled as accelerating the rate of wound healing or epithelization.
    3. Must not be labeled as a permanent dressing or artificial skin.
    4. Must not be labeled as a treatment or cure for any wound.

Common mistakes

  • Using as an Absorptive Dressing: Petrolatum gauze cannot absorb fluids. Applying it to heavily exuding wounds traps fluid and causes periwound maceration.
  • Confusing with Dental Bite Gauze: Dental extraction hemostasis requires plain sterile cotton sponges bitten firmly to form a clot, not medicated petrolatum gauze.
  • Attempting Resterilization: Leftover strips cannot be resterilized. Exposure compromises sterility; discard unused portions.
  • Overlooking Pouch Expiration: Degraded packaging risks barrier breach. Always verify pouch expiration stamps (see whether gauze expires).

Frequently asked questions

How long to keep a gauze after tooth extraction?

Following a standard tooth extraction, bite firmly on a sterile cotton gauze sponge for 30 to 60 minutes to establish an initial hemostatic clot. If oozing continues, place a fresh dry cotton sponge for another 30 to 45 minutes. Xeroform gauze is an impregnated surgical dressing, not routine dental bite gauze; it is used in oral surgery only when packed by a clinician for dry socket care.

How long to leave gauze on after tooth extraction?

Standard dental gauze should remain compressed over the extraction site for 30 to 60 minutes before gentle removal. Leaving dental gauze in place for extended hours after bleeding stops is unnecessary and risks dislodging the stabilizing clot during dry removal.

What is gauze?

Gauze is a lightweight fabric with an open weave or nonwoven structure, made from bleached cotton, rayon, or synthetic fibers. In healthcare, it is used for fluid absorption, wound coverage, cleansing, and anatomical packing. For structural details, see our guide on classification of medical gauze types.

What is a gauze?

In clinical practice, “a gauze” refers to an individual piece of gauze fabric, such as a sterile 2″ × 2″ or 4″ × 4″ sponge, pad, or strip designed for a specific clinical task.

What category of dressing is Xeroform?

Xeroform is categorized as an impregnated, non-adherent primary wound contact dressing. Under FDA classifications, it is regulated under Product Code FRO (“Dressing, Wound, Drug”) as an Unclassified Pre-Amendment device or Product Code NAD (“Dressing, Wound, Occlusive”, 21 CFR 878.4020).

What is Curad used for?

Curad is a medical brand produced by Medline Industries that supplies first-aid supplies, sterile pads, and Curad Xeroform Petrolatum Gauze dressings. Curad Xeroform dressings are used as non-adherent primary contact layers for donor sites, minor burns, lacerations, and sutured wounds.

What can I use instead of Xeroform dressing?

Alternatives include non-medicated petrolatum gauze (such as Vaseline gauze) for non-adherent moisture retention without bismuth, porous oil emulsion dressings (such as Adaptic), silicone contact layer sheets (such as Mepitel) for fragile skin, or non-stick pads (such as Telfa).

What is another name for an oil emulsion dressing?

An oil emulsion dressing is also known as a non-adherent emulsion dressing or a knitted cellulose acetate dressing impregnated with an emulsion blend. Well-known commercial examples include Adaptic and Kendall Xeroform Non-Occlusive Oil Emulsion Dressing.

Sources

  • U.S. Food and Drug Administration. (2016-10-03). 510(k) Premarket Notification K152970: Dynarex Xeroform Petrolatum Dressing. Center for Devices and Radiological Health. https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152970.pdf
  • U.S. Food and Drug Administration. (2019-09-13). 510(k) Premarket Notification K181478: Roosin Xeroform Petrolatum Dressing. Center for Devices and Radiological Health. https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181478.pdf
  • U.S. Food and Drug Administration. (1997-12-15). 510(k) Premarket Notification K973507: Kendall Xeroform Petrolatum Dressing. Center for Devices and Radiological Health. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K973507
  • U.S. Food and Drug Administration. (2026-10-26). Global Unique Device Identification Database (AccessGUDID): Cardinal Health 200, LLC Xeroform Device Listings. openFDA UDI Endpoint. https://api.fda.gov/device/udi.json
  • U.S. Food and Drug Administration. (2026-10-26). Product Classification Database: Code FRO (Dressing, Wound, Drug) & Code NAD (21 CFR 878.4020). CDRH Classification Database. https://api.fda.gov/device/classification.json
  • Centers for Medicare & Medicaid Services. (2026). Healthcare Common Procedure Coding System (HCPCS): Codes A6222, A6223, and A6266 (Impregnated Gauze Dressings). U.S. National Library of Medicine Clinical Tables API. https://clinicaltables.nlm.nih.gov/api/hcpcs/v3/search

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