Surgical Drape

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K931418 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Aperture

  Class II

  FDA 510(k) K895084 Active Cleared 27 Oct 1989

• Arthroscopic Leg Holder 434-21

  Class II

  FDA 510(k) K834076 Active Cleared 27 Dec 1983

• Surgical Drape and Gown Tray

  Class II

  FDA 510(k) K931456 Active Cleared 8 Jul 1994

• Various Sterile and Non-Sterile Surgical Drapes, (I.E., Disposables Minor Procedure Drapes, Large Aperture Drapes, Absor

  Class II

  FDA 510(k) K994199 Active Cleared 9 Jun 2000

• Enema Kit 'y' Design

  Class I

  FDA 510(k) K900847 Active Cleared 13 Apr 1990

• Enema Kit 'straight' Design

  Class I

  FDA 510(k) K900848 Active Cleared 13 Apr 1990

See all devices from Custom Medical Products, Ltd. →

• What types of surgical procedures is this drape intended to protect during surgery?

  This Surgical Drape is designed to maintain a sterile barrier in general and plastic surgery procedures. It isolates the surgical field to prevent contamination from external sources, ensuring a clean environment for the procedure. While it’s classified under product code KKX (surgical drapes), its intended use aligns with any surgery requiring a sterile field, not just specific procedures.

• Is this drape reusable, or is it meant to be used only once?

  This Surgical Drape is explicitly labeled as a single-use item. Reusing it could compromise sterility and integrity, potentially introducing contamination risks. Always follow sterile medical device protocols for storage and handling to ensure it remains uncontaminated before use.

• How should I store this drape to keep it sterile until surgery?

  Since it’s a sterile, disposable device, storage must adhere to standard sterile medical device protocols. Keep the drape in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposing it to moisture or physical damage, as this could compromise its sterility before use.

• What regulatory pathway was followed for this device’s approval?

  This Surgical Drape received FDA 510(k) clearance under the traditional review pathway (K-number K931418). The submission was classified as substantially equivalent to a predicate device and reviewed by the Surgical and Urological Devices (SU) Advisory Committee. The decision was made in 1994, confirming its compliance with U.S. regulatory standards for surgical drapes.