Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Le…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230610 FDA 510(k)
- FDA Product Code
- FYA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4040 FDA 510(k)
- Regulation Number
- 878.4040 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Disposable Surgical Gown classified under Level 3 and Level 4 protection standards, designed to provide barrier protection during surgical procedures. It is intended to shield both surgical personnel and patients from contamination by microorganisms, body fluids, and particulate matter, ensuring sterile field integrity during invasive procedures.
The gowns are supplied as single-use, sterile items and are regulated under FDA 510(k) clearance (K230610) and MDR compliance. They are available in three series—MF2103, MF2104 (Level 3), and MF2105 (Level 4)—with no specified MRI safety restrictions. Storage requires dry conditions, and they are intended for use in operating rooms and sterile environments.
Frequently asked questions
What are the key differences between the Level 3 and Level 4 surgical gowns in this series, and which one should I choose for high-risk procedures?
The Level 3 gowns (MF2103 and MF2104 series) and Level 4 gown (MF2105 series) differ primarily in their barrier protection standards, with Level 4 offering enhanced resistance to contamination. Level 3 gowns are suitable for standard surgical procedures where moderate protection is required, while Level 4 gowns are designed for high-risk or invasive procedures where maximum barrier protection against microorganisms, body fluids, and particulate matter is critical. Choose Level 4 for procedures involving high fluid exposure or prolonged contact with contaminated areas.
Are these gowns reusable, or do they need to be discarded after a single use, and why?
These gowns are explicitly labeled as single-use and supplied in sterile packaging. They are designed for one-time use only to maintain sterility and prevent cross-contamination between patients or procedures. Reusing them could compromise barrier integrity and introduce infection risks, which is why they are not intended for reuse.
How should I store these gowns to ensure they remain sterile and effective until use?
The gowns must be stored in dry conditions to preserve their sterility and structural integrity. Avoid exposure to moisture, heat, or direct sunlight, as these can degrade the material or compromise the sterile barrier. Keep them in their original packaging until ready for use, and ensure the storage area is clean and free from contaminants.
What regulatory pathways have these gowns undergone, and how does that affect their use in clinical settings?
These gowns are regulated under FDA 510(k) clearance (K230610) and comply with MDR (Medical Device Regulation) standards. The FDA clearance confirms they meet U.S. safety and performance requirements for surgical gowns, while MDR compliance ensures they align with European Union standards. Clinicians can rely on these approvals to confirm the gowns are suitable for use in operating rooms and sterile environments as intended.
Do these gowns have any restrictions on use in MRI environments, and if so, what should I be aware of?
The product description explicitly states there are no specified MRI safety restrictions for these gowns. However, since they are made of typical surgical fabric materials, clinicians should still verify compatibility with their facility’s MRI protocols, particularly if metallic components or conductive materials are present in the gown design. Always follow local MRI safety guidelines regardless of the manufacturer’s general statement.
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 Gown (Level 3, MF2103 Series), Disposable Surgical ..., Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical ..., K230610 - Disposable Surgical Gown (Level 3, MF2103 Seri...
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 | K230610 | Class II | Active |
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Manufacturer
- Manufacturer
- Dongguan Shin Yi Healthcare Products Factory
Sources (2)
- FDA 510(k) K230610 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026