Envirotex Reusable OR Wrapper and Custom Surgical Drape
510(k) K960045
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK960045 | Date5 Jun 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- Withdrawn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
- Full name
- Envirotex Reusable O.R. Wrapper and Custom Surgical Drape
- 510(k) Number
- FDA Product Code
- KKX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4370
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Envirotex Reusable OR Wrapper and Custom Surgical Drape is a reusable surgical drape designed to protect patients and surgical sites from microbial and environmental contamination during operative procedures. Classified under product code KKX as a Surgical Drape, it serves as a barrier to isolate incision sites while maintaining a sterile field in the operating room environment. Constructed for repeated use, it is intended to enhance procedural efficiency and reduce cross-contamination risks in surgical settings.
This device is supplied as a reusable item, requiring cleaning and reprocessing between uses to maintain sterility and functionality. It is intended for use in operating rooms and is regulated under FDA 510(k) clearance (K960045), classified as a Class II device under Special Controls. The drape is designed to accommodate custom surgical configurations, ensuring adaptability to various procedural needs. Storage and handling must comply with reprocessing guidelines to ensure safety and performance.
Other devices from The Sewing Source, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Envirotex Reusable OR Wrapper and Custom Surgical Drape used for?
The Envirotex Reusable OR Wrapper and Custom Surgical Drape is designed to act as a protective barrier during surgical procedures. It isolates incision sites from microbial and environmental contamination, helping maintain a sterile field in the operating room. This ensures patient safety and procedural efficiency by reducing the risk of cross-contamination.
How is the Envirotex Reusable OR Wrapper and Custom Surgical Drape supplied and prepared for use?
This device is supplied as a reusable item, meaning it must be cleaned and reprocessed between uses to ensure sterility and functionality. Proper reprocessing is essential to maintain its performance and safety for subsequent surgical procedures. Follow manufacturer guidelines for cleaning and handling to comply with regulatory standards.
Is the Envirotex Reusable OR Wrapper and Custom Surgical Drape single-use or reusable?
The Envirotex Reusable OR Wrapper and Custom Surgical Drape is explicitly designed for repeated use. Unlike single-use drapes, it requires thorough cleaning and reprocessing after each procedure to maintain its integrity and prevent contamination. This design supports procedural efficiency in high-volume surgical settings.
Can this drape accommodate different surgical configurations?
Yes, the Envirotex Reusable OR Wrapper and Custom Surgical Drape is engineered for adaptability. It is designed to fit custom surgical configurations, allowing it to be tailored to various procedural needs. This flexibility ensures it can be effectively used across a wide range of surgical applications while maintaining its protective function.
What storage and handling guidelines should be followed for this device?
Storage and handling of the Envirotex Reusable OR Wrapper and Custom Surgical Drape must adhere to reprocessing guidelines to preserve its sterility and functionality. After use, it should be cleaned according to manufacturer instructions and stored in a clean, dry environment until the next procedure. Proper storage prevents degradation and ensures the drape remains effective for future uses.