{
  "code": "KGO",
  "deviceName": "Surgeon'S Gloves",
  "deviceClass": "I",
  "regulationNumber": "878.4460",
  "panel": "General, Plastic Surgery",
  "definition": "A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 559,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 81,
    "last12Months": 29
  },
  "reviewDays": {
    "median": 98,
    "sampleSize": 559
  },
  "recalls": {
    "total": 44,
    "recent": [
      {
        "resNumber": "Z-1725-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.",
        "initiated": "2026-02-27"
      },
      {
        "resNumber": "Z-0096-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Ansell Healthcare Products LLC",
        "firmAsPublished": "Ansell Healthcare Products LLC",
        "reason": "Some surgical glove sterile pouches were not completely sealed.",
        "initiated": "2023-08-03"
      },
      {
        "resNumber": "Z-0097-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Ansell Healthcare Products LLC",
        "firmAsPublished": "Ansell Healthcare Products LLC",
        "reason": "Some surgical glove sterile pouches were not completely sealed.",
        "initiated": "2023-08-03"
      },
      {
        "resNumber": "Z-0902-2022",
        "status": "Completed",
        "recallClass": "Class II",
        "firm": "Cardinal Health 200, LLC",
        "firmAsPublished": "Cardinal Health 200, LLC",
        "reason": "Product was distributed without being sterilized.",
        "initiated": "2022-03-15"
      },
      {
        "resNumber": "Z-0838-2022",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Ansell Healthcare Products LLC",
        "firmAsPublished": "Ansell Healthcare Products LLC",
        "reason": "Transport company failed to stop at the border for required FDA inspection.",
        "initiated": "2022-02-19"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253060",
      "deviceName": "Sterile Latex Powder Free Surgical Gloves",
      "applicant": "Protect Gloves Company Limited",
      "company": "Protect Gloves Company Limited",
      "decisionDate": "2026-05-22",
      "dateReceived": "2025-09-22"
    },
    {
      "kNumber": "K250313",
      "deviceName": "Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid",
      "applicant": "Harps Europe Manufacturing GmbH",
      "company": "Harps Europe Manufacturing GmbH",
      "decisionDate": "2025-08-19",
      "dateReceived": "2025-02-03"
    },
    {
      "kNumber": "K240790",
      "deviceName": "Polyisoprene Surgical gloves",
      "applicant": "Suzhou Colour-Way New Material Co., Ltd.",
      "company": "Suzhou Colour-way New Material Co., Ltd.",
      "decisionDate": "2024-08-23",
      "dateReceived": "2024-03-22"
    },
    {
      "kNumber": "K232079",
      "deviceName": "Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl",
      "applicant": "Wrp Asia Pacific Sdn. Bhd.",
      "company": "WRP Asia Pacific Sdn Bhd",
      "decisionDate": "2024-03-28",
      "dateReceived": "2023-07-13"
    },
    {
      "kNumber": "K232444",
      "deviceName": "Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs",
      "applicant": "Grand Work Plastic Products Co., Ltd.",
      "company": "Grand Work Plastic Products Co., Ltd.",
      "decisionDate": "2023-12-20",
      "dateReceived": "2023-08-14"
    },
    {
      "kNumber": "K231902",
      "deviceName": "GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)",
      "applicant": "Ansell Healthcare",
      "company": "Ansell Healthcare, Inc.",
      "decisionDate": "2023-10-12",
      "dateReceived": "2023-06-28"
    },
    {
      "kNumber": "K231973",
      "deviceName": "PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove",
      "applicant": "Ineo Tech Sdn Bhd",
      "company": "Ineo Tech Sdn Bhd",
      "decisionDate": "2023-09-29",
      "dateReceived": "2023-07-03"
    },
    {
      "kNumber": "K231446",
      "deviceName": "Single-Use Latex Sterile Surgical Gloves (SG100)",
      "applicant": "Fitone Latex Products Co., Ltd. Guangdong",
      "company": "Fitone Latex Products Co., Ltd. Guangdong",
      "decisionDate": "2023-09-22",
      "dateReceived": "2023-05-18"
    },
    {
      "kNumber": "K230578",
      "deviceName": "Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl",
      "applicant": "Wrp Asia Pacific Sdn. Bhd.",
      "company": "WRP Asia Pacific Sdn Bhd",
      "decisionDate": "2023-08-31",
      "dateReceived": "2023-03-01"
    },
    {
      "kNumber": "K230079",
      "deviceName": "Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential",
      "applicant": "Ansell Healthcare Products, LLC",
      "company": "Ansell Healthcare Products LLC",
      "decisionDate": "2023-08-23",
      "dateReceived": "2023-01-10"
    }
  ],
  "topApplicants": [
    {
      "name": "Wrp Asia Pacific Sdn. Bhd.",
      "count": 20
    },
    {
      "name": "Molnlycke Health Care Us, LLC",
      "count": 16
    },
    {
      "name": "Ansell Perry",
      "count": 15
    },
    {
      "name": "Terang Nusa Sdn Bhd",
      "count": 15
    },
    {
      "name": "Wembley Rubber Products (M) Sdn Bhd",
      "count": 15
    }
  ],
  "topCompanies": [
    {
      "name": "WRP Asia Pacific Sdn Bhd",
      "count": 20,
      "spellings": 1
    },
    {
      "name": "Ansell Healthcare Products LLC",
      "count": 16,
      "spellings": 2
    },
    {
      "name": "Molnlycke Health Care Us, LLC",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "Ansell Perry",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Terang Nusa Sdn Bhd",
      "count": 15,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Protect Gloves Company Limited",
      "since": "2026-05-22",
      "kNumber": "K253060"
    },
    {
      "name": "Harps Europe Manufacturing GmbH",
      "since": "2025-08-19",
      "kNumber": "K250313"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 1,
        "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": "2025-08-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "KGO (Surgeon'S Gloves) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class I) (Z-1725-2026). 2 first-time filers in the last 12 months, Protect Gloves Company Limited and Harps Europe Manufacturing GmbH (K253060, K250313). The code is crowded, scoring 79 of 100 — 260 companies hold a clearance here and 2 arrived in the last 12 months (KGO:crowding).",
    "severity": 85,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class I)",
        "recordIds": [
          "Z-1725-2026"
        ],
        "severity": 85
      },
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, Protect Gloves Company Limited and Harps Europe Manufacturing GmbH",
        "recordIds": [
          "K253060",
          "K250313"
        ],
        "severity": 42
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 79 of 100 — 260 companies hold a clearance here and 2 arrived in the last 12 months",
        "recordIds": [
          "KGO: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%3AKGO"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKGO"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKGO"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKGO"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKGO"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKGO"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKGO"
    }
  ],
  "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": "2026-08-11T13:51:45.730Z"
}