Surgical Gown (FYA)
by Xianning Marveldas Protective Articles Co., Ltd. China EUDAMED510(k)
510(k) K212812 Product code FYA
Overview
This device is a surgical gown (product code FYA), a protective garment designed to maintain sterile barriers during surgical procedures. It is classified under the General, Plastic Surgery advisory committee category and is intended to shield healthcare personnel and patients from contamination by fluids and pathogens during invasive procedures.
The gown is supplied as a single-use item, adhering to FDA 510(k) clearance under the Traditional pathway (K212812) and EU MDR compliance. It is manufactured by Xianning Marveldas Protective Articles Co., Ltd., and must be stored in a clean, dry environment to preserve integrity before use. No MRI safety or reusable specifications are indicated in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK212812 | Date16 Nov 2022 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Full name
- Surgical Gown
- 510(k) Number
- FDA Product Code
- FYA
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4040
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
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Questions
What is the primary purpose of this surgical gown, and how does it protect during procedures?
This surgical gown is designed as a protective barrier to shield both healthcare personnel and patients from contamination by fluids and pathogens during invasive surgical procedures. Its construction maintains sterility, reducing the risk of cross-contamination in sterile fields.
Is this gown intended for reuse, or is it meant to be used only once?
This gown is explicitly labeled as a single-use item, meaning it should only be used once before disposal. Reuse is not recommended or supported by the manufacturer.
How should I store this gown before use to ensure it remains effective?
The gown must be stored in a clean, dry environment to preserve its integrity before use. Proper storage prevents degradation and ensures it remains ready for sterile surgical procedures.
What regulatory pathways does this gown follow, and how does it meet compliance standards?
This gown is cleared under the FDA’s 510(k) Traditional pathway (K212812) and complies with EU MDR (Medical Device Regulation). It is classified under product code FYA and falls under the General, Plastic Surgery advisory committee category.
Does this gown have any special considerations for use in MRI environments?
The provided data does not mention any MRI safety specifications for this gown, so its compatibility or restrictions in MRI environments are not indicated. Always verify compatibility with your facility’s MRI protocols if needed.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K212812
- EUDAMED