{
  "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": "2026-11-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "Y",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "OPH",
      "openfda": {
        "registration_number": [
          "3010220595",
          "3007048057",
          "3027157158"
        ],
        "fei_number": [
          "3010220595",
          "3007048057",
          "3027157158"
        ]
      },
      "review_panel": "HO",
      "medical_specialty": "HO",
      "device_name": "Radiation Attenuating Medical Glove",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "General Hospital",
      "device_class": "1",
      "definition": "Radiations attenuating medical gloves are medical gloves that are used during medical or surgical procedures involving radiation to shield the hands of the wearer from scattered radiation exposure. The gloves offer some degree of protection to the hand from radiation exposure as well as protection from transmission of infectious agents.  The use of these gloves includes procedures that require the use of fluoroscopy or radiography.  In addition to meeting the requirements for examination or surgeon¿s gloves, manufacturers should have technical data to show that their attenuation claims meet the energy range of x-rays normally used in medical procedures.",
      "regulation_number": "880.6250",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}