Contamination Containment Drape
by Engineering Controls For Medicine
510(k) K954212
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954212 | Date23 Oct 1995 | 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- Withdrawn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 Contamination Containment Drape is a surgical drape and drape accessory, classified under 21 CFR 878.4370. It is designed as a protective patient covering to isolate surgical incision sites from microbial and other forms of contamination, ensuring a sterile field during procedures. Constructed from natural or synthetic materials, this device helps maintain aseptic conditions by preventing contamination from external sources. Its primary function aligns with maintaining surgical site integrity and reducing infection risks during operations.
This device is supplied as a single-use item, intended for use in surgical settings where contamination control is critical. It is regulated under FDA 510(k) clearance (K954212) and falls under the product code KKX, designated for general and plastic surgery applications. The drape is not specified as MRI-safe, reusable, or requiring specific sterility beyond standard surgical drape practices. Storage should follow manufacturer guidelines for sterile barrier integrity, and its use is governed by the regulatory framework established for surgical drapes and accessories.
Questions
AI-generated answers, 1 Oct 2026
What is the Contamination Containment Drape used for?
The Contamination Containment Drape is designed to create a sterile barrier over surgical incision sites. Its primary purpose is to isolate the surgical area from microbial and other external contaminants, helping maintain aseptic conditions during procedures. This reduces the risk of surgical site infections, which is critical in maintaining patient safety and procedural integrity.
Is the Contamination Containment Drape reusable or single-use?
This drape is explicitly intended for single-use only. Its design and regulatory classification under 21 CFR 878.4370 as a surgical drape accessory emphasize its disposable nature to ensure sterility and prevent cross-contamination between patients or procedures. Reuse could compromise its protective properties and violate infection control standards.
What materials is the Contamination Containment Drape made from?
The drape is constructed from either natural or synthetic materials, though the exact composition isn’t specified beyond this general description. The choice of materials is intended to provide a reliable barrier against contamination while maintaining flexibility and ease of use during surgical procedures. This aligns with standard practices for surgical drapes to balance durability and sterility.
How should the Contamination Containment Drape be stored?
Storage must adhere to manufacturer guidelines to preserve the sterile barrier integrity of the drape. This typically involves keeping it in its original, sealed packaging until use and avoiding exposure to moisture, heat, or physical damage. Proper storage ensures the drape remains effective in preventing contamination during surgical procedures.
Is the Contamination Containment Drape approved for MRI use?
The device is not specified as MRI-safe in the available documentation. If MRI compatibility is required for a procedure, additional verification or a different drape may be necessary. Always confirm device specifications with the manufacturer or clinical guidelines before use in MRI environments.