Surgical Apparel
510(k) K954549
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954549 | Date18 Apr 1996 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- FYC
- 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 an Isolation, Surgical Gown, classified under FDA regulation 878.4040. It is designed as a protective barrier to prevent contamination during surgical procedures, adhering to standards for surgical apparel in general and plastic surgery settings. The gowns are intended to maintain sterile field integrity while minimizing the risk of cross-contamination between patient and healthcare provider.
The Surgical Apparel is supplied as a single-use, non-sterile product (unless packaged in a sterilized pouch) and is regulated under FDA 510(k) clearance K954549, classified as a Class II device. It is intended for use in surgical environments, including operating rooms and procedural suites, where barrier protection is required. Multiple reference codes (e.g., FYC) and FEI numbers identify specific variants, though exact sizes or configurations are not detailed in the regulatory submission. Compliance with FDA standards ensures its suitability for sterile procedures, though MRI safety or reusable variants are not indicated.
Other devices from Global Healthcare, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Global Surgical Isolation Gown designed for?
The Global Surgical Isolation Gown is designed as a protective barrier to prevent contamination during surgical procedures. It helps maintain sterile field integrity while minimizing the risk of cross-contamination between patients and healthcare providers. This makes it particularly suitable for use in operating rooms and procedural suites, including settings for general and plastic surgery.
Is the Global Surgical Isolation Gown sterile?
The gown is supplied as a non-sterile product by default. However, it can be provided in a sterilized pouch, allowing for sterile use when required for specific procedures. Always check the packaging details to confirm sterility status before use.
How is the Global Surgical Isolation Gown classified and regulated?
This gown is classified under FDA regulation 878.4040 and is designated as a Class II medical device. It holds FDA 510(k) clearance with the reference number K954549, indicating it is deemed substantially equivalent to a legally marketed predicate device. Compliance with FDA standards ensures its suitability for sterile surgical environments.
Are there different models or sizes available for the Global Surgical Isolation Gown?
The device data lists multiple FEI numbers (e.g., 3009750712, 3006400329) and a product code (FYC), which typically represent different variants or configurations. However, specific details regarding exact sizes or configurations are not provided in the regulatory submission. Contact Global Healthcare, Inc. for precise sizing or variant information.
Can the Global Surgical Isolation Gown be reused?
No, the Global Surgical Isolation Gown is intended for single-use only. Reusing this gown could compromise its protective barrier properties and increase the risk of contamination. Always adhere to single-use guidelines to maintain patient and clinician safety.