Orex Surgeon's Gown

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K944827 ↗

FDA Product Code

FYA

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Isolyser Orex Surgeon's Caps, Hoods, Bouffant Caps

  Class I

  FDA 510(k) K942200 Active Cleared 7 Aug 1995

• Orex(R) O.r Equipment Drapes

  Class II

  FDA 510(k) K945755 Active Cleared 25 May 1995

• Isolyser Sharps Management System Sms

  Class II

  FDA 510(k) K943626 Active Cleared 16 Jun 1995

• Orex (18X18 X-Ray Detectable)

  Class I

  FDA 510(k) K940766 Active Cleared 19 Dec 1994

• Orex Surgeon's Vest

  Class II

  FDA 510(k) K961083 Active Cleared 23 Aug 1996

• Isolyser

  Unclassified

  FDA 510(k) K940765 Active Cleared 19 Dec 1994

See all devices from Thantex Specialties, Inc. →

• What is the Orex Surgeon’s Gown designed for?

  The Orex Surgeon’s Gown is a protective garment specifically engineered to act as a barrier against bodily fluids during surgical procedures. Its primary purpose is to maintain sterility in the surgical field and minimize infection risks for both the patient and the surgical team by preventing contamination from fluids.

• Is the Orex Surgeon’s Gown intended for single-use or reuse?

  This gown is explicitly designed for single-use only. Its sterile packaging and intended use in surgical settings ensure that it remains uncontaminated and safe for one procedure, adhering to best practices for infection control and patient safety.

• How is the Orex Surgeon’s Gown supplied, and what does sterility mean in this context?

  The gown is supplied in sterile packaging, which means it undergoes processes to eliminate or reduce microorganisms to levels that ensure safety for surgical use. Sterility is critical in surgical settings to prevent postoperative infections, and the packaging maintains this sterility until the gown is opened for use.

• What regulatory approval does the Orex Surgeon’s Gown hold, and what does that mean?

  The Orex Surgeon’s Gown holds FDA 510(k) clearance, granted in 1995. This clearance indicates that the device has been reviewed by the FDA and deemed substantially equivalent to a legally marketed predicate device, meeting regulatory standards for safety and effectiveness as a surgical gown.

• What product code category does the Orex Surgeon’s Gown fall under?

  The gown is classified under FDA product code FYA, which categorizes it as a surgical gown. This classification helps regulators and healthcare providers identify its intended use and compliance requirements within the broader medical device framework.