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U.S. FDA Medical Device Conductive Shoe & 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 Conductive Shoe & Shoe Cover companies with:

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