{
  "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": 3
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3038187455",
        "fei_number": "3038187455",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "PT K-TECH INDUSTRIES",
        "address_line_1": "Jalan Surfaktan Kavling D19, KEK Sei Mangkei, Desa/Kelurahan Sei Mangkei, Kec. Bosar Maligas, Kab.",
        "address_line_2": "",
        "city": "Simalungun Sumatera Utara",
        "state_code": "",
        "iso_country_code": "ID",
        "zip_code": "",
        "postal_code": "21183",
        "us_agent": {
          "name": "Max Lee",
          "business_name": "",
          "bus_phone_area_code": "909",
          "bus_phone_num": "9801678",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "maxli@basicmedical.com",
          "address_line_1": "805 Barrington Ave",
          "address_line_2": "",
          "city": "Ontario",
          "state_code": "CA",
          "iso_country_code": "US",
          "zip_code": "91764",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "PT K-Tech Industries",
          "owner_operator_number": "10093197",
          "official_correspondent": {
            "first_name": "Aditya",
            "middle_initial": "",
            "last_name": "Pratama",
            "subaccount_company_name": "",
            "phone_number": "62-812-7620683-x"
          },
          "contact_address": {
            "address_1": "Jalan Surfaktan Kavling D19, KEK Sei Mangkei, Desa/Kelurahan Sei Mangkei, Kec. Bosar Maligas, Kab.",
            "address_2": "",
            "city": "Simalungun",
            "state_code": "ID-SU",
            "state_province": "Sumatera Utara",
            "iso_country_code": "ID",
            "postal_code": "21183"
          }
        }
      },
      "pma_number": "",
      "k_number": "K243792",
      "products": [
        {
          "product_code": "LZC",
          "created_date": "2025-04-13",
          "owner_operator_number": "10093197",
          "exempt": "",
          "openfda": {
            "device_name": "Medical Glove, Specialty",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.6250",
            "device_class": "1"
          }
        },
        {
          "product_code": "QDO",
          "created_date": "2025-04-13",
          "owner_operator_number": "10093197",
          "exempt": "",
          "openfda": {
            "device_name": "Fentanyl And Other Opioid  Protection Glove",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.6250",
            "device_class": "1"
          }
        },
        {
          "product_code": "OPJ",
          "created_date": "2025-04-13",
          "owner_operator_number": "10093197",
          "exempt": "",
          "openfda": {
            "device_name": "Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.6250",
            "device_class": "1"
          }
        },
        {
          "product_code": "LZA",
          "created_date": "2025-04-13",
          "owner_operator_number": "10093197",
          "exempt": "",
          "openfda": {
            "device_name": "Polymer Patient Examination Glove",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.6250",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}