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

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