Surgical Isolation Gown
by Wuhan Zonsen Medical Products Co., Ltd
510(k) K212357
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK212357 | Date20 Jan 2022 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- FYC
- FDA applicant
- Wuhan Zonsen Medical Products Co., Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4040
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Surgical Isolation Gown is a protective barrier designed to isolate the wearer from potential contamination during surgical procedures. Classified as a Class II medical device, it provides fluid resistance and barrier protection against splashes, sprays, and droplets, ensuring patient and healthcare worker safety in sterile environments.
This gown is intended for single-use in operating rooms, surgical suites, and other controlled clinical settings. Supplied in sterile packaging, it adheres to FDA 510(k) and MDR regulatory standards, with multiple registration numbers (e.g., 3009750712) for compliance tracking. Sizes and variants are listed under product codes such as FYC, ensuring compatibility with standard surgical protocols.
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Questions
AI-generated answers, 18 Sep 2026
What types of clinical settings is this gown intended for, and how does it protect against contamination?
This Surgical Isolation Gown is designed for single-use in controlled environments like operating rooms and surgical suites. It acts as a protective barrier against fluid exposure, offering resistance to splashes, sprays, and droplets to safeguard both the wearer and patients during procedures. Its fluid-resistant properties align with standards for sterile environments.
Is this gown sterile when packaged, and how should it be stored to maintain sterility?
Yes, the Surgical Isolation Gown is supplied in sterile packaging to ensure cleanliness before use. To preserve sterility, it should be stored in its original, unopened packaging in a clean, dry area away from direct sunlight, extreme temperatures, or contaminants. Avoid placing it on surfaces or shelves where it could be exposed to dust or moisture.
Are there multiple sizes or variants available, and how do I determine the correct fit?
The gown is available in multiple sizes and variants, categorized under product codes like FYC, which align with standard surgical protocols. Sizing typically follows common medical gown dimensions, but exact fit may vary by manufacturer. Check the packaging or manufacturer’s sizing guide for compatibility with the wearer’s height and build, ensuring proper coverage and mobility during procedures.
How do I verify the regulatory compliance of this gown for my facility?
This gown complies with both FDA 510(k) and MDR (Medical Device Regulation) standards, with multiple registration numbers (e.g., 3009750712) for traceability. For your facility, confirm the specific registration number matches your procurement records or check the manufacturer’s documentation. The product code (FYC) and regulatory route (Class II, substantially equivalent) are also key identifiers for compliance verification.