Qualtex Surgical Drape Modification
510(k) K913486
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913486 | Date5 Feb 1992 | 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- Withdrawn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
- 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 Qualtex Surgical Drape Modification is a protective patient covering classified as a surgical drape and drape accessory (Product Code KKX). It is designed from natural or synthetic materials to isolate a surgical incision site from microbial and other contaminants, ensuring a sterile field during procedures. This modification includes a plastic wound protector that adheres to the skin or is placed within a wound to cover exposed edges, reducing the risk of infection and maintaining surgical site integrity. The device is intended for use in sterile surgical environments where contamination control is critical.
This device is supplied as a single-use item and is regulated under FDA 510(k) clearance (K913486), granted in February 1992 following a review by the Surgical and Urological Devices Subcommittee (SU). It is intended for use in operating rooms or sterile surgical settings, where it must be stored in a clean, dry environment to preserve sterility. The device adheres to FDA’s traditional clearance pathway and is not labeled for MRI compatibility or reusable applications. No additional regulatory markings or third-party certifications are referenced in the submission data.
Other devices from Deroyal Industries, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Qualtex Surgical Drape Modification designed to do?
The Qualtex Surgical Drape Modification is a protective patient covering designed to isolate a surgical incision site from microbial and other contaminants. It includes a plastic wound protector that either adheres to the skin or is placed within a wound to cover exposed edges, helping to maintain a sterile field and reduce the risk of infection during surgical procedures.
Is this device intended for single-use or reuse?
This device is explicitly intended for single-use only. It is not labeled or approved for reuse, as repeated use could compromise sterility and increase infection risks. Always follow the manufacturer’s guidelines to ensure proper use and disposal.
How should the Qualtex Surgical Drape Modification be stored?
To preserve sterility, the device must be stored in a clean, dry environment, away from direct sunlight or moisture. Ensure packaging remains intact until immediate use in a sterile surgical setting, such as an operating room.
Does this device have any special regulatory markings or certifications?
The Qualtex Surgical Drape Modification is regulated under the FDA’s 510(k) clearance pathway (K913486) and is not labeled for MRI compatibility or reusable applications. No third-party certifications are referenced in the submission data.
What type of materials is the Qualtex Surgical Drape Modification made from?
The device is constructed from natural or synthetic materials, chosen to provide a protective barrier against contaminants while maintaining flexibility and adherence to the surgical site. The plastic wound protector is integrated to enhance isolation of the incision.