{
  "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": "2026-09-07",
    "results": {
      "skip": 0,
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    }
  },
  "results": [
    {
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        "Disposable Medical Face Mask (S663BE, S663BEF, S663BT, S663BTF)",
        "Disposable Medical Face Mask (S643BE, S643BEF, S643BT, S643BTF)",
        "Disposable Medical Face Mask (M643BEF, M643BT, M643BTF)",
        "Disposable Medical Face Mask (M653BE, M653KE, M653BEF, M653KEF, M653BT, M653BTF)",
        "Disposable Medical Face Mask (M663BEF, M663BTF)",
        "Disposable Medical Face Mask (S653BE, S653KE, S653BEF, S653KEF, S653BT, S653BTF)"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "9614598",
        "fei_number": "3003191210",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Dongguan Sure On Plastic and Fiber Product Co., Ltd.",
        "address_line_1": "BLDG. 2, CHU FO LING",
        "address_line_2": "168 INDUSTRIAL AREA, TANG XIA",
        "city": "DONG GUAN CITY Guangdong",
        "state_code": "",
        "iso_country_code": "CN",
        "zip_code": "",
        "postal_code": "--",
        "us_agent": {
          "name": "Legrand Lindor",
          "business_name": "Makrite North America",
          "bus_phone_area_code": "855",
          "bus_phone_num": "5648398",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "Legrand@makritenorthamerica.com",
          "address_line_1": "12 Breck St",
          "address_line_2": "",
          "city": "Milton",
          "state_code": "MA",
          "iso_country_code": "US",
          "zip_code": "02186",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Makrite Industries Inc.",
          "owner_operator_number": "8043227",
          "official_correspondent": {
            "first_name": "Cynthia",
            "middle_initial": "",
            "last_name": "Shih",
            "subaccount_company_name": "",
            "phone_number": "886-2-26982419-x"
          },
          "contact_address": {
            "address_1": "11F-5., No.79, Sec.1, Xintai 5th Rd., Xizhi Dist.,",
            "address_2": "",
            "city": "New Taipei City",
            "state_code": "TW-NWT",
            "state_province": "",
            "iso_country_code": "TW",
            "postal_code": "221"
          }
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      },
      "pma_number": "",
      "k_number": "K252650",
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          "product_code": "FXX",
          "created_date": "2026-06-26",
          "owner_operator_number": "8043227",
          "exempt": "",
          "openfda": {
            "device_name": "Mask, Surgical",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4040",
            "device_class": "2"
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}