Surgical Gown (FYA)
by Wuhan DYMEX Healthcare Co., Ltd
510(k) K211809
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211809 | Date18 Oct 2021 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Surgical Gown
- 510(k) Number
- FDA Product Code
- FYA
- FDA applicant
- Wuhan Dymex Healthcare 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, 1 Oct 2026
This device is a surgical gown, classified under the FDA product code FYA. It is a protective garment designed to shield healthcare personnel and patients from contamination during surgical and medical procedures. Constructed from fluid-resistant materials, it provides a barrier against blood, bodily fluids, and microorganisms, adhering to standards for sterile or clean environments. Its design ensures compliance with infection control protocols in operating rooms and clinical settings.
The gown is supplied as a single-use, disposable item, intended for use in sterile or clean environments such as operating rooms, surgical suites, and procedural areas. It is regulated under FDA 510(k) clearance (K211809) and classified as substantially equivalent to predicate devices. No specific MRI safety or reusable specifications are noted; storage should follow manufacturer guidelines for dry, clean conditions to maintain integrity. The product adheres to FDA and international standards for surgical attire.
Other devices from Wuhan DYMEX Healthcare Co., Ltd
Questions
AI-generated answers, 1 Oct 2026
What is the Dymex Surgical Gown designed for?
The Dymex Surgical Gown is a protective garment engineered to shield healthcare workers and patients from contamination during surgical and medical procedures. Its fluid-resistant material creates a barrier against blood, bodily fluids, and microorganisms, ensuring compliance with infection control protocols in operating rooms, surgical suites, and procedural areas. This design is critical for maintaining sterile environments where contamination risks are high.
Is the Dymex Surgical Gown reusable or single-use?
The Dymex Surgical Gown is explicitly designed as a single-use, disposable item. This classification aligns with best practices for infection control, as reuse could compromise sterility and integrity, potentially exposing patients and staff to contamination risks. Single-use gowns are also more hygienic and cost-effective for high-volume clinical settings.
How should the Dymex Surgical Gown be stored?
To preserve the gown’s protective properties, storage must follow manufacturer guidelines for dry and clean conditions. Exposure to moisture, heat, or direct sunlight can degrade the fluid-resistant materials, compromising its ability to shield against contamination. Proper storage ensures the gown remains effective for its intended use in sterile environments.
What regulatory clearance does the Dymex Surgical Gown hold?
The Dymex Surgical Gown holds FDA 510(k) clearance under the reference number K211809. This clearance confirms it is classified as substantially equivalent to predicate devices under FDA product code FYA, meeting regulatory standards for surgical attire. The clearance process ensures the gown adheres to safety and performance requirements for use in healthcare settings.
Can this gown be used in non-sterile areas like clinics?
While the Dymex Surgical Gown is primarily intended for sterile environments like operating rooms and surgical suites, its fluid-resistant design may offer limited protection in clean, non-sterile areas such as clinics or procedural rooms where contamination risks are lower. However, for optimal infection control, it is best suited for settings where sterility is critical, as specified by the manufacturer’s guidelines.