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U.S. FDA Medical Device Radiographic Protective Glove Requirements


FDA Medical Device Definition: A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.

Registrar Corp assists Radiographic Protective Glove companies with:

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