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U.S. FDA Medical Device Examination Gown Requirements

FDA Medical Device Definition: An examination gown is a device intended for medical purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination.

Registrar Corp assists Examination Gown companies with:

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