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U.S. FDA Medical Device Operating-Room Shoe Cover 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 Operating-Room Shoe Cover companies with:

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