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U.S. FDA Medical Device Non-Surgical Isolation Gown 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 Non-Surgical Isolation Gown companies with:

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