{
  "code": "FYA",
  "deviceName": "Gown, Surgical",
  "deviceClass": "II",
  "regulationNumber": "878.4040",
  "panel": "General, Plastic Surgery",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 296,
    "last12Months": 8
  },
  "adverseEvents": {
    "total": 52,
    "last12Months": 8
  },
  "reviewDays": {
    "median": 128,
    "sampleSize": 296
  },
  "recalls": {
    "total": 129,
    "recent": [
      {
        "resNumber": "Z-1563-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.",
        "initiated": "2026-01-28"
      },
      {
        "resNumber": "Z-1424-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.",
        "initiated": "2026-01-07"
      },
      {
        "resNumber": "Z-2129-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.",
        "initiated": "2026-01-07"
      },
      {
        "resNumber": "Z-2130-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.",
        "initiated": "2026-01-07"
      },
      {
        "resNumber": "Z-0897-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Cardinal Health 200, LLC",
        "firmAsPublished": "Cardinal Health 200, LLC",
        "reason": "Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.",
        "initiated": "2025-11-12"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261949",
      "deviceName": "NYES Tuff Cuff L3 Disposable Gowns",
      "applicant": "New York Embroidery Studio",
      "company": "New York Embroidery Studio",
      "decisionDate": "2026-07-10",
      "dateReceived": "2026-06-11"
    },
    {
      "kNumber": "K252575",
      "deviceName": "Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)",
      "applicant": "New York Embroidery Studio (NYES)",
      "company": "New York Embroidery Studio (NYES)",
      "decisionDate": "2026-06-04",
      "dateReceived": "2025-08-14"
    },
    {
      "kNumber": "K260725",
      "deviceName": "BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)",
      "applicant": "Hindernis DE Mexico, S.A.P.I. DE C.V.",
      "company": "Hindernis DE Mexico, S.A.P.I. DE C.V.",
      "decisionDate": "2026-05-12",
      "dateReceived": "2026-03-05"
    },
    {
      "kNumber": "K253243",
      "deviceName": "Cardinal Health™ Poly Reinforced Surgical Gown",
      "applicant": "Cardinal Health 200, LLC",
      "company": "Cardinal Health 200, LLC",
      "decisionDate": "2026-04-28",
      "dateReceived": "2025-09-29"
    },
    {
      "kNumber": "K253003",
      "deviceName": "Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)",
      "applicant": "Hubei Xinxin Non-Woven Co., Ltd.",
      "company": "Hubei Xinxin Non-Woven Co., Ltd.",
      "decisionDate": "2026-04-20",
      "dateReceived": "2025-09-19"
    },
    {
      "kNumber": "K251860",
      "deviceName": "Copioumed AAMI 3 Surgical Gown",
      "applicant": "Copioumed International, Inc.",
      "company": "Copioumed International, Inc.",
      "decisionDate": "2026-02-26",
      "dateReceived": "2025-06-17"
    },
    {
      "kNumber": "K252301",
      "deviceName": "Henan Yadu Level 4 Surgical Gowns (Reinforced)",
      "applicant": "Yadu Medical (Henan) Co., Ltd.",
      "company": "Yadu Medical (Henan) Co., Ltd.",
      "decisionDate": "2026-02-04",
      "dateReceived": "2025-07-24"
    },
    {
      "kNumber": "K250564",
      "deviceName": "Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)",
      "applicant": "Yadu Medical (Henan) Co., Ltd.",
      "company": "Yadu Medical (Henan) Co., Ltd.",
      "decisionDate": "2025-12-03",
      "dateReceived": "2025-02-26"
    },
    {
      "kNumber": "K243522",
      "deviceName": "ViVi® Toga Premium",
      "applicant": "Thi Total Healthcare Innovation GmbH",
      "company": "Thi Total Healthcare Innovation GmbH",
      "decisionDate": "2025-05-30",
      "dateReceived": "2024-11-14"
    },
    {
      "kNumber": "K242937",
      "deviceName": "Dream Medi Sterile Surgical Gown (SurgicalGownUL)",
      "applicant": "Dae Myung Chemical Co., Ltd. (Vietnam)",
      "company": "Dae Myung Chemical Co., Ltd. (Vietnam)",
      "decisionDate": "2025-05-05",
      "dateReceived": "2024-09-25"
    }
  ],
  "topApplicants": [
    {
      "name": "Standard Textile Co., Inc.",
      "count": 14
    },
    {
      "name": "Medline Industries, Inc.",
      "count": 13
    },
    {
      "name": "Kimberly-Clark Corp.",
      "count": 11
    },
    {
      "name": "Allegiance Healthcare Corp.",
      "count": 8
    },
    {
      "name": "The Sewing Source, Inc.",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Medline Industries, LP",
      "count": 16,
      "spellings": 2
    },
    {
      "name": "Standard Textile Co., Inc.",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "Kimberly-Clark Corporation",
      "count": 12,
      "spellings": 2
    },
    {
      "name": "Allegiance Healthcare Corp.",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "The Sewing Source, Inc.",
      "count": 8,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "New York Embroidery Studio",
      "since": "2026-07-10",
      "kNumber": "K261949"
    },
    {
      "name": "New York Embroidery Studio (NYES)",
      "since": "2026-06-04",
      "kNumber": "K252575"
    },
    {
      "name": "Hindernis DE Mexico, S.A.P.I. DE C.V.",
      "since": "2026-05-12",
      "kNumber": "K260725"
    },
    {
      "name": "Hubei Xinxin Non-Woven Co., Ltd.",
      "since": "2026-04-20",
      "kNumber": "K253003"
    },
    {
      "name": "Copioumed International, Inc.",
      "since": "2026-02-26",
      "kNumber": "K251860"
    },
    {
      "name": "Yadu Medical (Henan) Co., Ltd.",
      "since": "2025-12-03",
      "kNumber": "K250564"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "FYA (Gown, Surgical) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1563-2026, Z-1424-2026, Z-2129-2026, Z-2130-2026, Z-0897-2026). 6 first-time filers in the last 12 months, including New York Embroidery Studio and New York Embroidery Studio (NYES) (K261949, K252575, K260725, K253003, K251860). The code is crowded, scoring 94 of 100 — 169 companies hold a clearance here and 8 arrived in the last 12 months (FYA:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1563-2026",
          "Z-1424-2026",
          "Z-2129-2026",
          "Z-2130-2026",
          "Z-0897-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "6 first-time filers in the last 12 months, including New York Embroidery Studio and New York Embroidery Studio (NYES)",
        "recordIds": [
          "K261949",
          "K252575",
          "K260725",
          "K253003",
          "K251860"
        ],
        "severity": 46
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 94 of 100 — 169 companies hold a clearance here and 8 arrived in the last 12 months",
        "recordIds": [
          "FYA:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AFYA"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFYA"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFYA"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AFYA"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AFYA"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AFYA"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AFYA"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.700Z"
}