{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "has_donation_id_number": "false",
      "mri_safety": "Labeling does not contain MRI Safety Information",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "false",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "KP Protective Face Mask is a single-use, disposable surgical face mask intended to be worn by healthcare professionals to protect both the patient and the wearer from the transfer of microorganisms, body fluids, and particulate material. The mask covers the nose and mouth and is secured with ear loops. It is intended for use in medical and surgical settings. The mask is non-sterile and for single use only.",
      "public_device_record_key": "f1d02201-17f3-4e66-b9f3-d3417b6dd64a",
      "has_serial_number": "false",
      "public_version_date": "2026-02-27",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "1",
      "labeler_duns_number": "695645209",
      "is_labeled_as_no_nrl": "true",
      "identifiers": [
        {
          "id": "08809755250164",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "08809755250171",
          "quantity_per_package": "50",
          "package_status": "In Commercial Distribution",
          "package_type": "Box"
        },
        {
          "id": "08809755250171",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "true",
      "version_or_model_number": "Large-White",
      "has_manufacturing_date": "false",
      "brand_name": "KP Protective Face Mask",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "FXX",
          "name": "Mask, Surgical",
          "openfda": {
            "device_name": "Mask, Surgical",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4040",
            "device_class": "2"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "K243342",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "+0314951042",
          "email": "Jihyekwon@kptrading.co.kr"
        }
      ],
      "company_name": "KP trading Co., Ltd.",
      "public_version_status": "New",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "66199",
          "name": "Surgical/medical face mask, non-antimicrobial, single-use",
          "definition": "A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2026-02-19"
    }
  ]
}