Surgical Garments

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

510(k) Number

K880484 ↗

FDA Product Code

FYC

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Cone Masks, Various Types of Surgical Cone Masks

  Class II

  FDA 510(k) K883828 Active Cleared 3 Oct 1988

• Dispos. & Sponge Forceps Pean Artery

  Class I

  FDA 510(k) K843074 Active Cleared 17 Aug 1984

• Masks, Various Types of Surgical Masks

  Class II

  FDA 510(k) K883827 Active Cleared 17 Nov 1988

• Utility Scissors Disposable Items

  Class I

  FDA 510(k) K843075 Active Cleared 5 Sep 1984

• Fixed Vol. Dispensers, Adjust Vol-Hunpip

  Class I

  FDA 510(k) K843073 Active Cleared 24 Aug 1984

• Various Tyes of Surgical Garments

  Class I

  FDA 510(k) K870617 Active Cleared 9 Mar 1987

See all devices from Greene International Corp. →

• What are surgical garments used for?

  Surgical garments are medical devices designed for use in surgical procedures to provide protection and maintain a sterile environment during operations.

• Are surgical garments single-use or reusable?

  Surgical garments are supplied as single-use items, meaning they are intended for one-time use only to ensure sterility and prevent cross-contamination between patients.

• What sizes and models of surgical garments are available?

  Surgical garments are available in various sizes to accommodate different clinical needs, though specific model details are not provided in the available information.

• How are surgical garments regulated?

  Surgical garments are regulated under FDA 510K clearance, which means they have been determined to be substantially equivalent to other legally marketed devices.