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U.S. FDA Medical Device Surgical Cap 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 Cap companies with:

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