Disposable Surgical Isolation Gown (FYC)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Isolation gown EUDAMED
- Device Name
- isolation gown EUDAMED
- Model / Reference
- 356164 EUDAMED509342 EUDAMED356406 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973122512277 EUDAMED06973122512598 EUDAMED06973122512291 EUDAMED
- Basic UDI-DI
- 697312251IG10073 EUDAMED
- 510(k) Number
- K212422 FDA 510(k)
- FDA Product Code
- FYC FDA 510(k)
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4040 FDA 510(k)
- Regulation Number
- 878.4040 FDA 510(k)
- Market of Registration
- Norway EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Disposable Surgical Isolation Gown is a single-use protective garment designed to prevent contamination from blood, body fluids, and infectious agents during surgical and medical procedures. It provides a barrier to protect both healthcare workers and patients from cross-infection, adhering to regulatory standards for surgical isolation attire.
Supplied as a sterile, disposable item, this gown is intended for use in controlled clinical environments such as operating rooms and surgical suites. Authorized under FDA 510(k) clearance (K212422) and MDR compliance, it falls under Class II medical devices (Product Code FYC, Regulation Number 878.4040). Multiple registration numbers (e.g., 3009750712) are associated with its distribution, ensuring traceability and adherence to global regulatory requirements.
Frequently asked questions
What types of procedures is this gown intended to protect against contamination during?
This Disposable Surgical Isolation Gown is specifically designed to prevent contamination from blood, body fluids, and infectious agents during surgical and medical procedures in controlled clinical environments like operating rooms and surgical suites. Its barrier properties help protect both healthcare workers and patients from cross-infection, making it suitable for high-risk procedures where sterility and contamination control are critical.
Is this gown reusable, or is it meant for single-use only?
The gown is explicitly labeled as a single-use item. It is supplied sterile and intended for one-time use to ensure maximum protection and prevent cross-contamination between patients or procedures. Reuse is not recommended or supported by the manufacturer.
How should I store this gown to maintain its sterility before use?
Since the gown is sterile upon packaging, it should be stored in its original sealed packaging in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. Avoid opening or handling the gown until immediately before use to preserve sterility. Follow manufacturer guidelines for shelf-life and storage conditions if additional details are provided.
Are there multiple sizes or models available for this gown?
The provided data does not specify exact sizes or models, but the Disposable Surgical Isolation Gown is categorized under FDA Product Code FYC (Surgical Gowns) and includes multiple registration numbers, indicating it may be available in various configurations to accommodate different clinical needs. For precise sizing options, refer to the manufacturer’s product documentation or contact Crown Name Disposable Hygiene Products directly.
What regulatory pathways does this gown follow, and how does that affect its use?
This gown is authorized under FDA 510(k) clearance (K212422) and MDR compliance, classifying it as a Class II medical device under Regulation Number 878.4040. These pathways ensure it meets U.S. and EU safety and performance standards for surgical isolation attire. The clearance does not dictate clinical indications but confirms its suitability for controlled environments like operating rooms, where infection control is prioritized.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Disposable Surgical Isolation Gown (K212422) — FDA 510 (k) | Innolitics, Buy Disposable Isolation Gown - Crown Name, K212422 - Disposable Surgical Isolation Gown | FDA 510 (k), Disposable Surgical Isolation Gown — FDA K212422
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212422 | Class II | Active |
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Manufacturer
- Manufacturer
- Crown Name Disposable Hygiene Products Fty. Ltd.
- FDA Applicant
- Crown Name Disposable Hygiene Products Fty., Ltd.
Sources (4)
- FDA 510(k) K212422 24 fields · synced Sep 18, 2026
- EUDAMED 7f82427f-d152-4ae9-ab11-67bb3a5f46b7 61 fields · synced Jul 9, 2026
- EUDAMED 3eda84ac-4475-443a-9acc-9bc3135adfe4 61 fields · synced Aug 2, 2026
- EUDAMED 71886920-d903-45db-88f0-c43179458d0b 61 fields · synced Aug 3, 2026