{
  "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": "2026-05-25",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Waukegan",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "3651 Birchwood Dr.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "QPC",
      "openfda": {
        "registration_number": [
          "1417592",
          "3013502418",
          "3015499242",
          "",
          "1043644",
          "3007339875",
          "3011547453",
          "1423537",
          "3038356900",
          "1423205",
          "1921846",
          "3013557562",
          "3015960676",
          "3015820879",
          "3013410562",
          "3042129477",
          "3004513970",
          "3008959420"
        ],
        "fei_number": [
          "1417592",
          "3013502418",
          "3015499242",
          "",
          "1043644",
          "3001236905",
          "3011547453",
          "3007339875",
          "3001239227",
          "3038356900",
          "1921846",
          "3013557562",
          "3015960676",
          "3015820879",
          "3013410562",
          "3042129477",
          "3004513970",
          "3008959420"
        ],
        "device_name": "Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4040",
        "device_class": "2"
      },
      "zip_code": "60085",
      "applicant": "Cardinal Health200, LLC",
      "decision_date": "2019-04-26",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Cardinal HealthTM Poly-Coated Open-Back Protective Gown",
      "advisory_committee": "SU",
      "contact": "Caroline  Miceli",
      "expedited_review_flag": "",
      "k_number": "K182830",
      "state": "IL",
      "date_received": "2018-10-05",
      "review_advisory_committee": "HO",
      "postal_code": "60085",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}