Provision Surgical Helmet System

• 3 recalls, same reason

  • Terminated Z-1043-03 FDA Unclassified (pre-2012) ·initiated 27 Jun 2003
  • Terminated Z-1040-03 FDA Unclassified (pre-2012) ·initiated 27 Jun 2003
  • Terminated Z-1041-03 FDA Unclassified (pre-2012) ·initiated 27 Jun 2003

  Lack of assurance of sterility, due to the possibility of an incomplete package seal.

510(k) Number

K972832 ↗

FDA Product Code

FYA

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Depuy, Inc. →

• What type of procedures is the Provision Surgical Helmet System intended for?

  It is designed for use in general and plastic surgery operating rooms, where maintaining a sterile field for the surgical team is critical. The helmet acts as a barrier to reduce airborne contamination during these procedures.

• How is the helmet supplied and is it intended for single‑use or reuse?

  The device is supplied as a complete helmet system, meaning all components needed for use are packaged together. It is a reusable piece of equipment that can be cleaned and re‑sterilized according to the manufacturer’s instructions, rather than being discarded after one case.

• What regulatory pathway was used for market clearance?

  The system received clearance through a traditional 510(k) submission (K972832) on 21 October 1997, indicating it was found substantially equivalent to a legally marketed predicate device under the FDA’s Class II surgical gown category.

• Are there any size options or model variations for the helmet?

  The available data only reference a single model, the Provision Surgical Helmet System, without specifying multiple sizes or variants. Users should verify with the supplier whether different head sizes are accommodated within the single model.

• What storage conditions are recommended for the helmet system?

  While the description does not detail storage requirements, standard practice for reusable surgical headgear is to keep it in a clean, dry environment protected from dust and moisture until it is cleaned and sterilized for the next use.