{
  "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",
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      "third_party_flag": "N",
      "city": "Hong Kong",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "# 138 Shatin Rural Committee Rd., Shatin, N.T.",
      "address_2": "Unit 1706, Tower 2, Grand Central Plz.",
      "statement_or_summary": "Summary",
      "product_code": "QPC",
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        "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",
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      "applicant": "Bam Corporation Limited",
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      "country_code": "CN",
      "device_name": "Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns",
      "advisory_committee": "SU",
      "contact": "MARY  MEJAES",
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      "k_number": "K160337",
      "state": "",
      "date_received": "2016-02-08",
      "review_advisory_committee": "HO",
      "postal_code": "",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}