{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Bien Hoa City",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "Rd. 2, Bien Hoa Industrial Zone 1",
      "address_2": "An Binh Ward",
      "statement_or_summary": "Summary",
      "product_code": "QPC",
      "openfda": {
        "registration_number": [
          "3044026004",
          "3042129477",
          "3013410562",
          "3015960676",
          "3011547453",
          "1043644",
          "3015820879",
          "3038356900",
          "3007339875",
          "3015499242",
          "3013502418",
          "1417592",
          "3008959420",
          "3004513970",
          "1423537",
          "1921846",
          "3013557562",
          "1423205"
        ],
        "fei_number": [
          "3044026004",
          "3042129477",
          "3013410562",
          "3015960676",
          "3011547453",
          "3001236905",
          "3015820879",
          "3038356900",
          "3001239227",
          "3007339875",
          "3015499242",
          "3013502418",
          "1417592",
          "3008959420",
          "3004513970",
          "1043644",
          "1921846",
          "3013557562"
        ],
        "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": "810000",
      "applicant": "Dong Nai Garment Corporation (Donagamex)",
      "decision_date": "2021-12-17",
      "decision_code": "SESE",
      "country_code": "VN",
      "device_name": "Donagamex Blue Performance Protective Gown",
      "advisory_committee": "SU",
      "contact": "Bui The Kich",
      "expedited_review_flag": "",
      "k_number": "K203821",
      "state": "",
      "date_received": "2020-12-29",
      "review_advisory_committee": "HO",
      "postal_code": "810000",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}