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

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