Boundary Reinforced OR Gown

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

510(k) Number

K811958 ↗

FDA Product Code

FYA

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Boundary Surgical Drape

  Class II

  FDA 510(k) K812962 Active Cleared 20 Nov 1981

• Contain X-Ray Detectable Lap Sponge

  Class I

  FDA 510(k) K801768 Active Cleared 20 Aug 1980

• Boundary Single-Use Craniotomy Sheet

  Class II

  FDA 510(k) K820758 Active Cleared 29 Apr 1982

• Boundary Single-Use Drapes

  Class II

  FDA 510(k) K813450 Active Cleared 22 Jan 1982

• Boundary Process Change

  Class II

  FDA 510(k) K821564 Active Cleared 2 Jul 1982

• Boundary

  Class II

  FDA 510(k) K820116 Active Cleared 23 Feb 1982

See all devices from The Buckeye Cellulose Corp. →

• What is the BOUNDARY REINFORCED OR GOWN used for?

  The BOUNDARY REINFORCED OR GOWN is a surgical gown intended for use in the operating room to provide a barrier against fluids and microorganisms during surgical procedures, specifically in general and plastic surgery settings.

• Is the BOUNDARY REINFORCED OR GOWN sterile or non-sterile when supplied?

  The BOUNDARY REINFORCED OR GOWN is supplied non-sterile, meaning it requires sterilization by the user before use in a surgical procedure, as indicated in the device description.

• Is the BOUNDARY REINFORCED OR GOWN intended for single-use or reuse?

  The BOUNDARY REINFORCED OR GOWN is a single-use device is explicitly described as single-use, meaning it is intended to be used once and then discarded after a single procedure to maintain barrier integrity and prevent cross-contamination.

• What regulatory pathway was used for the BOUNDARY REINFORCED OR GOWN?

  The BOUNDARY REINFORCED OR GOWN was cleared through the FDA 510(k) process under submission K811958, demonstrating substantial equivalence to a legally marketed predicate device.

• Who manufactures the BOUNDARY REINFORCED OR GOWN and where is it made?

  The BOUNDARY REINFORCED OR GOWN is manufactured by The Buckeye Cellulose Corp., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States.