Surgeon's Gown

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

510(k) Number

K920404 ↗

FDA Product Code

FYC

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Amsco Sterile Recoveries Absorbent Towels

  Class II

  FDA 510(k) K931143 Active Cleared 8 Sep 1994

• Surgical Drapes, Modification

  Class II

  FDA 510(k) K931146 Active Cleared 13 Jun 1994

• Surgical Drape

  Class II

  FDA 510(k) K921049 Active Cleared 1 Oct 1992

• Sterile Surgeon's Gown

  Class II

  FDA 510(k) K920405 Active Cleared 18 Aug 1992

• Recoveries Autoclavable Resuable Wrap -- Fac. Use

  Class II

  FDA 510(k) K931874 Active Cleared 10 Jun 1994

• Reusable Liquidproof Bootie

  Class I

  FDA 510(k) K925815 Active Cleared 9 Jul 1993

See all devices from Amsco Sterile Recoveries, Inc. →

• What is the primary purpose of the Surgeon's Gown?

  The Surgeon's Gown is designed to function as a protective barrier for both the patient and the surgical staff during clinical procedures.

• Is this device regulated by the FDA?

  Yes, this device is regulated under FDA 510(k) clearance K920404 and is classified as a Class 2 medical device under regulation number 878.4040.

• What is the regulatory classification of this surgical gown?

  The Surgeon's Gown is classified as a Class 2 medical device, which is a designation for devices that require more than general controls to ensure safety and effectiveness, as indicated by its regulation number 878.4040.