Trilaminate Drapes/Tiburon

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K023419 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Nitrile Powder-Free Examination Gloves

  Class I

  FDA 510(k) K022765 Active Cleared 11 Oct 2002

• Powder Free Sterile Latex Examination Gloves

  Class I

  FDA 510(k) K001141 Active Cleared 9 May 2000

• Sterile Nitrile Powder-Free Examination Gloves

  Class I

  FDA 510(k) K010211 Active Cleared 15 Feb 2001

• Ultraderm Sterile Latex Powdered Surgical Sloves with Protein Content Labeling Claim (50 Micrograms or Less)

  Class I

  FDA 510(k) K991205 Active Cleared 13 Oct 1999

• Convertors Drape Material

  Class II

  FDA 510(k) K964125 Active Cleared 23 Dec 1996

• Convertors Impervious Shoe Covers

  Class I

  FDA 510(k) K970815 Active Cleared 27 Mar 1997

See all devices from Allegiance Healthcare Corp. →

• What is the Trilaminate Tiburon drape designed for?

  The Trilaminate Tiburon drape is a sterile barrier drape engineered to isolate patients during surgical procedures, particularly in general and plastic surgery. Its trilaminate construction provides superior fluid resistance and contamination control, reducing the risk of microbial penetration while ensuring patient comfort and procedural efficiency.

• How are these drapes supplied and intended for use?

  The Trilaminate Tiburon drapes are supplied as single-use, sterile devices exclusively for intraoperative use in operating rooms. They are not designed for reuse or MRI environments, and their sterile packaging must remain intact until use.

• What storage conditions are required to maintain sterility?

  To preserve sterility, these drapes must be stored in a clean, dry environment away from direct sunlight or extreme temperatures. The sterile barrier packaging should not be opened until immediately before use, and any exposed drapes should be discarded.

• Are there different sizes or models available?

  The Trilaminate Tiburon drapes are available in standard sizes, though specific dimensions are not detailed in the regulatory submission. For precise sizing requirements, refer to the manufacturer’s product documentation or consult Allegiance Healthcare’s technical support.

• How does the trilaminate material improve performance compared to standard drapes?

  The trilaminate design combines multiple layers to create a stronger barrier against fluids and microbial penetration, reducing the risk of contamination during surgery. This enhances procedural safety while maintaining flexibility and patient comfort—critical for complex surgeries like those in plastic surgery.