Verify the Cleared Label Before Buying Hemostatic Gauze

A hospital materials manager or emergency medical services (EMS) procurement specialist replacing expired bleeding-control consumables faces an immediate challenge. Vendor catalogs present an array of kaolin-impregnated and chitosan-based hemostatic gauzes under well-known trade names such as QuikClot, Celox, ChitoGauze, and Chito-SAM alongside newer market entrants. Product descriptions frequently emphasize clotting speed or tactical deployment and treat superficially similar rolls as interchangeable.

A defensible purchase starts with the regulatory filing, not the catalog slogan. In the United States, hemostatic gauze is a regulated medical device. Permitted kit placement depends on the cleared indication, the product code, and whether the SKU is prescription or over-the-counter.

Hemostatic gauze is medical gauze impregnated or coated with a hemostatic material, most often kaolin or chitosan. FDA describes the external-use category as acting predominantly by physical means: absorbing moisture so platelets clump, and providing a tamponade effect on topical wounds. That description is a regulatory identification, not a ranking of clinical performance.

In the regulatory framework of the U.S. Food and Drug Administration (FDA), marketed hemostatic gauzes fall into two primary, non-interchangeable pathways depending on the intended anatomical application and duration of contact:

• External-Use Hemostatic Wound Dressings (Product Code QSY): Cleared to temporarily control bleeding and cover external wounds. FDA identifies the technical method as predominantly physical. QSY is an unclassified pre-amendment category. Unclassified does not mean exempt from premarket review. Every QSY device requires 510(k) clearance and is not GMP-exempt, so the device quality-system regulation in 21 CFR Part 820 still applies. Many older clearances, GUDID listings, and recall notices still show legacy product code FRO (Dressing, Wound, Drug).

• Non-Absorbable Hemostatic Gauze for Temporary Internal Use (21 CFR 878.4454, Product Code POD): A Class II prescription device under 21 CFR 878.4454 for temporary control of severely bleeding wounds, including surgical wounds, traumatic injuries, and organ-space bleeding. The identification says the gauze is intended to be removed once the patient is stabilized. The category was created by the De Novo grant DEN160012, applicable June 30, 2017, and codified by final order on February 15, 2018 (83 FR 6794).

graph TD
  A["Hemostatic Gauze Buying Decision"] --> B{"Which labeled use is on the SKU?"}
  B -->|"External topical wounds"| C["FDA Product Code QSY"]
  B -->|"Temporary internal surgical use"| D["21 CFR 878.4454 / Product Code POD"]
  B -->|"Absorbable hemostatic agent"| E["21 CFR 878.4490 Class III PMA"]

  C --> F["Unclassified Pre-Amendment"]
  F --> G["510(k) still required"]
  F --> H["Not exempt from 21 CFR Part 820"]
  G --> I{"Which statement is on this SKU?"}
  I -->|"Traumatic external bleeding"| J["Confirm the Rx statement"]
  I -->|"Superficial cuts and abrasions"| K["Confirm the OTC statement"]

  D --> L["Class II prescription device"]
  L --> M["Special controls in 878.4454"]
  M --> N["Radiographic detection"]
  M --> O["Labeled maximum time in the body"]
  M --> P["Remove visible material by irrigation"]

  E --> Q["Absorbable agents such as cellulose or gelatin"]
  Q --> R["Different device, PMA required"]

QSY and POD are not interchangeable purchasing categories. An external-use QSY clearance does not include the temporary-internal-use identification in 21 CFR 878.4454, and it does not by itself supply the radiopacity, particulate, sterility, shelf-life, and labeling special controls that apply to POD devices. A tray or kit built for temporary internal use needs a SKU whose clearance is POD, not an external-only dressing with a similar brand name.

Understanding the landscape of commercial hemostatic gauze requires examining the foundational 510(k) clearances and De Novo orders upon which modern product lines are built. Manufacturers frequently iterate on packaging dimensions, folding styles, and branding while anchoring their regulatory claims to established clearances.

Kaolin-Based Dressings: The QuikClot Combat Gauze family traces to 510(k) K072474, cleared as QuikClot eX on October 16, 2007, and to K123387, QuikClot Hemostatic Dressing, cleared April 12, 2013. The K072474 summary describes standard non-woven gauze with kaolin bound by glycerin, and states that kaolin promotes hemostasis without the heat generation and burning risk of the earlier QuikClot hemostatic agent. That sentence is about the cleared gauze versus the earlier granular agent. It is not a performance claim for every later SKU. Temporary internal use of QuikClot Control+ follows the De Novo grant DEN160012, which created 21 CFR 878.4454.

Chitosan-Based Dressings: Chitosan dressings in this comparison are cleared external-use devices under QSY, not a separate clinical class. Celox Rapid (K110386) was cleared May 10, 2011. Celox Rapid X-Ray Gauze (K230589) was cleared November 17, 2023, with Celox Rapid and ChitoGauze XR Pro (K153582) as predicates. The K230589 indications text is temporary external use to control moderate to severe bleeding, and the same statement says it may also be used to control bleeding of lacerations, minor cuts, and abrasions. The summary introduces that text as the prescription-use statement. The comparison table does not copy a separate Rx and OTC split from the K110386 file. K133121, cleared May 22, 2014, names two configurations. Chito-SAM 100 is the prescription configuration: a temporary external dressing to control moderate to severe bleeding and to manage external abrasions and lacerations. Chito-SAM Active is the over-the-counter configuration, indicated to control bleeding of lacerations, minor cuts, and abrasions. Axiostat (K172324) was cleared February 23, 2018 as an OTC chitosan dressing substantially equivalent to Chito-SAM Active, with that same laceration, minor-cut, and abrasion indication. Match the instructions on the SKU in hand to the named configuration. The moderate-to-severe prescription statement on Chito-SAM 100 is not the traumatic-bleeding statement on K072474.

A product family is not uniformly prescription or over-the-counter. One 510(k) can carry two labeled-use statements, and individual SKUs can be distributed under only one of them. The GUDID record for QuikClot Combat Gauze model 0200, for example, is prescription yes and over-the-counter no, even though K072474 contains both statements.

The K072474 indications for use, cleared October 16, 2007, contain two statements:

• Prescription (Rx) Labeled Use: The prescription statement says QuikClot eX is intended for temporary external use to control traumatic bleeding. That is the labeled-use text. It does not, by itself, describe a technique or a patient population.

• Over-the-Counter (OTC) Labeled Use: The over-the-counter statement says QuikClot eX is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.

K133121 should be read by configuration, not by brand. Chito-SAM 100 is prescription use for moderate to severe bleeding and for external abrasions and lacerations. Chito-SAM Active is over-the-counter use for lacerations, minor cuts, and abrasions. Do not rewrite the Chito-SAM 100 statement as the K072474 traumatic-bleeding wording, and do not put the Active over-the-counter statement on a prescription SKU. Axiostat (K172324) is an OTC dressing for external wounds, cleared as substantially equivalent to Chito-SAM Active, for lacerations, minor cuts, and abrasions.

The distinction sets the purchasing boundary. A professional Combat Gauze SKU that carries the manufacturer's caution—CAUTION: Federal (USA) law restricts these devices to sale or use by or on the order of a physician—is being sold under a prescription restriction. A public-access kit needs a SKU whose own label and instructions carry the over-the-counter statement, not a prescription SKU from the same brand family.

A military or training recommendation is not an FDA labeled use. Reviews note that Combat Gauze, Celox gauze, and ChitoGauze have been recommended in U.S. military Tactical Combat Casualty Care guidelines. That selection status does not change the cleared indication printed on a civilian SKU.

Temporary internal use is a different purchase. 21 CFR 878.4454 identifies non-absorbable hemostatic gauze as a prescription device placed temporarily to control severely bleeding wounds, such as surgical wounds and traumatic injuries, and intended to be removed once the patient is stabilized. An external-only QSY dressing does not carry that identification.

Class II status under 21 CFR 878.4454 adds special controls. For a buyer, those controls are a file checklist, not a clinical protocol:

• Radiographic Detection: Animal performance testing must show that the device can be radiographically detected, and non-clinical testing must include radiopacity testing. Confirm the detectability evidence and the labeled marker for the SKU being bought.

• Comprehensive Biocompatibility: The device must be demonstrated to be biocompatible. The regulation does not list a fixed panel of ISO 10993 tests in the special control. Ask for the biocompatibility evaluation the sponsor used, and do not invent a test list the file does not contain.

• Mechanical and Particulate Characterization: Required non-clinical tests are in vitro clot assessment, particulate release, physical characterization including swelling percent and particulate size, chemical characterization, radiopacity, and mechanical integrity including tensile strength and tear strength.

• Sterility Assurance and Shelf Life: Performance data must demonstrate sterility, and shelf-life data must show continued sterility, package integrity, and device functionality over the identified shelf life. A sterility assurance level of 10^-6 appears in specific 510(k) summaries, including K072474 and K230589. It is not written into 21 CFR 878.4454 as a universal number, so request the sterility claim for the SKU rather than assuming 10^-6.

• Mandatory Labeling Cautions: Labeling must include instructions to remove all visible device components by irrigation, the maximum time the device may be left in the body, a shelf life, a contraindication for intravascular use, and a warning about the potential for adhesion formation.

Later clearances changed the labeled use of QuikClot Control+ only. K220971, cleared December 14, 2022, adds cardiac surgical procedures and bleeding from bone surfaces after sternotomy. The summary says the dressing may be left in place up to 48 hours and is not indicated for intraluminal vascular use. FDA's database record for K243553 shows a March 18, 2025 substantial-equivalence decision, regulation 878.4454, product code POD, and subsequent product code QSY. The broader indication wording—temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding—comes from Teleflex's April 30, 2025 release, which should be checked against the K243553 summary and the current instructions for use before it is copied into a specification.

Teleflex's same release says the EU label is worded differently and that the device was commercialized in the EU in 2024. That is a manufacturer statement, not an independent reading of EU MDR classification. A U.S. facility should stock the SKU whose instructions match the FDA clearance, and should treat a parallel EU label as a different labeled use until the two texts are compared.

To eliminate ambiguity during competitive tendering, procurement specialists should require suppliers to complete a standardized specification worksheet. Relying on vendor catalog summaries often leaves safety-critical fields unreported.

A rigorous procurement discipline requires treating any field omitted from a vendor's submission as Unknown / Needs Data. Shelf life is one of the fields vendors leave blank. In the K230589 comparison table, Celox Rapid X-Ray Gauze and its primary predicate, Celox Rapid, each list a five-year shelf life, and the secondary predicate ChitoGauze XR Pro lists shelf life as unknown. The same summary ties sterility of Celox Rapid X-Ray Gauze to a SAL of 10^-6 under BS EN 556-1:2001 and ISO 11137:2017. Those figures belong to that submission. An unrecorded field on another SKU stays unknown.

The purchase file is not the unit that arrives. Receiving is where the device identifier, the lot, and the pouch seal are checked against the clearance.

Representative clearances describe foil pouches: K072474 is a foil pouch irradiated to a SAL of 10^-6, and Axiostat is gamma-irradiated and foil-bagged. Those are packaging claims for those devices, not a universal pouch specification. What receiving can see is seal damage, crushing, and a lot number.

Two Class 2 recalls show why the lot and the seal belong on the receiving record:

• FDA Class 2 Recall Z-0211-2022: Z-Medica initiated the recall on September 22, 2021. FDA terminated it on June 11, 2024. The record covers QuikClot Combat Gauze for temporary external use to control traumatic bleeding, model or part 200, lot 12645, primary DI 00841495102004, 510(k) K072474, product code FRO. The manufacturer reason is lack of packaging seal integrity that may result in a sterile barrier breach.

• FDA Class 2 Recall Z-2612-2017: Z-Medica initiated the recall on May 17, 2017. FDA terminated it on June 15, 2018. The record covers QuikClot TraumaPad, a sterile, soft, white, X-ray detectable hemostatic dressing, part 460, lot 7313, 510(k) K123387, product code FRO. The manufacturer reason is that a packaging breach may compromise sterility. The recall text also repeats the topical-dressing indication for cuts, lacerations, and abrasions and for temporary treatment of severely bleeding surgical and traumatic wounds. It does not state a pad dimension.

Both recalls are lot-specific. Receiving should record the lot, check the device identifier in AccessGUDID, and set aside cartons with crushed corners or damaged foil pouches for the supplier-review path already used for sterile-pouch damage. A damaged pouch is evidence to record. It is not, by itself, a determination that the lot is unsterile.

For standardized receiving workflows, facilities should integrate the procedures detailed in MedDeviceGuide: Recording Sterile-Pouch Damage at Goods Receipt, and reference MedDeviceGuide: Tracing Mixed-Lot Consumables During a Recall to isolate suspect lots across tiered warehouse shelving without halting unaffected kit assembly lines.

The AccessGUDID record for primary DI 00841495102004 is QuikClot Combat Gauze, model 0200, from Z-MEDICA, LLC. It shows prescription use yes, over-the-counter no, single-use yes, packaged as sterile, 510(k) K072474, and product code FRO, Dressing, Wound, Drug. The GMDN term is non-organic haemostatic agent, code 47917. The same record has no storage-handling data and no device sizes, which is a reminder that GUDID does not replace the label. Barcode fields to capture are covered in UDI and GUDID for Medical Consumables: What Receiving Teams Should Capture from Labels.

Maintaining regulatory integrity requires drawing clear boundaries between non-absorbable hemostatic gauze and adjacent wound care technologies. Procurement documentation must not conflate distinct device classifications:

• Exclusion of Thrombin and Biologics: The QSY device name is hemostatic wound dressing without thrombin or other biologics. A dressing that adds thrombin or another biologic is outside that product code. This guide does not classify those combination products.

• Absorbable Hemostatic Agents (21 CFR 878.4490): 21 CFR 878.4490 identifies an absorbable hemostatic agent or dressing as a device intended to produce hemostasis by accelerating the clotting process of blood, and states that it is absorbable. The category is Class III, and a PMA approval has been required before commercial distribution since May 28, 1976. Brand examples such as oxidized cellulose or gelatin belong in that category only when their own approval matches it. Plain non-hemostatic dressings are a separate specification, covered in Specify Wound Dressings by FDA Identification, Not Catalog Name.

• Adjacent Expandable Sponges and GI Hemostats: 21 CFR 878.4452 is a separate Class II category: a nonabsorbable expandable hemostatic sponge for temporary internal use, placed in junctional, non-compressible wounds not amenable to tourniquet use. It is a sponge, and it may include an applicator. It is not hemostatic gauze, and a junctional wound is not a reason to buy a QSY dressing. Intraluminal gastrointestinal hemostatic devices are a further adjacent category in Part 878. They are outside this comparison.

• Clinical Equivalence and Comparative Ranking: This guide does not rank products or give application instructions. The American Red Cross Scientific Advisory Council's June 2019 advisory says there is a well-established body of evidence for hemostatic gauze and that hemostatic dressings appear effective for bleeding control compared with regular gauze where a tourniquet is not amenable. It also says data quality makes it difficult to determine whether any individual product is superior, and that the review did not cover cost, material, or shelf life. Cost, material degradation, and shelf-life economics stay outside this page. What this page adds is the labeled-use and clearance evidence a buyer can check.

Long-term procurement reliability depends on the quality terms in the supply agreement. Sourcing teams can use the quality-agreement article for purchasing information, change control, and outsourced processes, as outlined in Quality Agreements for Consumable Suppliers: Purchasing Information, Change Control, and Outsourced Processes, and use Labeled Storage and Transport for Medical Consumables: Temperature, Humidity, and Distribution Evidence for how to read the temperature, humidity, and distribution conditions printed on the label.