Sterile Surgeon's Gown, Modification

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

510(k) Number

K931144 ↗

FDA Product Code

FYA

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 Sterile Surgeon’s Gown, Modification primarily used for in a clinical setting?

  This gown is designed as a protective barrier to maintain aseptic conditions during surgical procedures. It helps prevent contamination of the surgical field, patient, and healthcare personnel by acting as a shield against pathogens and debris in sterile environments like operating rooms.

• Is this gown intended for single-use or can it be reused after sterilization?

  The Sterile Surgeon’s Gown, Modification is explicitly supplied in a sterile package for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and protective integrity.

• How is the gown packaged and stored to ensure sterility?

  The gown comes in a sterile package, meaning it is pre-sterilized and sealed to maintain sterility until use. Storage should follow manufacturer guidelines to preserve the sterile barrier—typically in a clean, dry environment away from direct sunlight or extreme temperatures until opened.

• What regulatory pathway was followed for FDA clearance of this gown?

  This device received FDA 510(k) clearance (K931144) under product code FYA, classified as substantially equivalent to a predicate device. The submission was reviewed by the Orthopedic and Rehabilitation Devices Panel (SU) and determined to be substantially equivalent (SESE) under a traditional review process.