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U.S. FDA Medical Device Surgical Apparel Accessories 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 Surgical Apparel Accessories companies with:

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