{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 27
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Dynarex PowderFree Vinyl Gloves - S, M, L, XL"
      ],
      "establishment_type": [
        "Export Device to the United States But Perform No Other Operation on Device"
      ],
      "registration": {
        "registration_number": "3010363542",
        "fei_number": "3010363542",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "EIKON DEVICE INC.",
        "address_line_1": "689 Innovation Drive",
        "address_line_2": "",
        "city": "Kingston Ontario",
        "state_code": "",
        "iso_country_code": "CA",
        "zip_code": "",
        "postal_code": "K7K 7E6",
        "us_agent": {
          "name": "FDAIMPORTS.COM LLC",
          "business_name": "",
          "bus_phone_area_code": "410",
          "bus_phone_num": "2202800",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "registration@fdaimports.com",
          "address_line_1": "2631 Housley Road, #1211",
          "address_line_2": "",
          "city": "Annapolis",
          "state_code": "MD",
          "iso_country_code": "US",
          "zip_code": "21401",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Eikon Device Inc.",
          "owner_operator_number": "10044469",
          "official_correspondent": {
            "first_name": "Dean",
            "middle_initial": "",
            "last_name": "Byrnes",
            "subaccount_company_name": "",
            "phone_number": "1-613-6342713-x"
          },
          "contact_address": {
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            "address_2": "",
            "city": "Kingston",
            "state_code": "CA-ON",
            "state_province": "Ontario",
            "iso_country_code": "CA",
            "postal_code": "K7K7E6"
          }
        }
      },
      "pma_number": "",
      "k_number": "K022091",
      "products": [
        {
          "product_code": "LYZ",
          "created_date": "2013-06-17",
          "owner_operator_number": "10044469",
          "exempt": "",
          "openfda": {
            "device_name": "Vinyl Patient Examination Glove",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.6250",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}