Various Utility/Surgical Drape, Sterile, Disposabl

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K920346 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Disposable Skin Staple Remover

  Class I

  FDA 510(k) K920283 Active Cleared 22 May 1992

• Minor Laceration Tray W/ Instrument, Sterile, Disp

  Class II

  FDA 510(k) K920517 Active Cleared 11 May 1992

• Sterile Water

  Class II

  FDA 510(k) K933526 Active Cleared 10 Mar 1994

• Tracheostomy Care Kit

  Class II

  FDA 510(k) K921281 Active Cleared 27 Aug 1992

• Mono-Lex System: Infectious Mononucleosis Latex

  Class II

  FDA 510(k) K902541 Active Cleared 28 Jun 1990

• Continuous Epidural Anesthesia Tray

  Class II

  FDA 510(k) K945671 Active Cleared 16 Feb 1995

See all devices from Trinity Laboratories, Inc. →

• Are these drapes reusable or intended for single-use only, and why does that matter in a surgical setting?

  These drapes are explicitly designed for single-use only, as stated in the description. This is critical in surgical settings because reusing disposable medical devices can introduce contamination risks, compromise sterility, and violate infection control protocols. The FDA’s classification under product code KKX and the manufacturer’s emphasis on sterility packaging reinforce that each drape is meant for one procedure, ensuring patient safety and compliance with sterile field requirements.

• What sizes and configurations are available, and how do I know which one to choose for a specific procedure?

  The drapes come in various sizes and configurations, including fenestrated (with cutouts for surgical access) and universal (adaptable to different body parts) options. The choice depends on the procedure: fenestrated drapes are ideal for surgeries requiring precise access (e.g., abdominal or orthopedic procedures), while universal drapes offer flexibility for general use. The manufacturer’s packaging should indicate the specific size or type, but clinicians should match the drape to the patient’s anatomy and the surgical approach to maintain an effective sterile field.

• Do I need to sterilize these drapes before use, or are they ready to apply immediately after opening?

  No additional sterilization is required—the drapes are packaged sterile by the manufacturer and cleared for immediate use in sterile surgical settings. This is explicitly stated in the description, ensuring they meet FDA standards for single-use medical devices without further processing. Always verify the package integrity (e.g., seals, expiration dates) before use to confirm sterility.

• How do these drapes help prevent contamination during surgery, and what materials are they designed to absorb?

  These drapes create and maintain a sterile field by acting as a barrier against microbial transmission from the patient’s skin, instruments, and the environment. They are engineered to absorb fluids (e.g., blood, bodily fluids) to prevent leakage and contamination of the operative site. While the specific materials aren’t detailed here, the FDA’s classification under KKX and the manufacturer’s focus on fluid absorption imply they’re designed to minimize spill risks while adhering to surgical standards for sterility and durability.

• What should I do if the drape packaging is damaged or the expiration date has passed?

  If the drape packaging is compromised (e.g., torn seals, punctures) or the expiration date has passed, do not use it. Damaged packaging or expired sterile drapes cannot guarantee sterility, increasing infection risks. Follow your facility’s protocols for disposing of compromised sterile items and obtain a new, intact drape from a fresh package. Always check the packaging before opening to ensure it meets manufacturer specifications for sterility.