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U.S. FDA Medical Device Surgical Helmet Requirements

FDA Medical Device Definition: Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Registrar Corp assists Surgical Helmet companies with:

  • FDA Surgical Helmet Establishment Registration
  • FDA Surgical Helmet Listing
  • FDA Surgical Helmet Label Requirements and Exceptions
  • FDA Surgical Helmet Import Information
  • FDA Surgical Helmet Detentions (Surgical Helmet Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Surgical Helmet Manufacturers (Surgical Helmet Suppliers)
       - Surgical Helmet Distributors
       - Surgical Helmet Processors
       - Surgical Helmet Repackers
       - Surgical Helmet Relabelers
       - Surgical Helmet Exporters
       - Surgical Helmet Importers
For more information about Surgical Helmet Medical Devices, simply click below:

U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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