{
  "code": "LYY",
  "deviceName": "Latex Patient Examination Glove",
  "deviceClass": "I",
  "regulationNumber": "880.6250",
  "panel": "General Hospital",
  "definition": "A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 1954,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 8,
    "last12Months": 1
  },
  "reviewDays": {
    "median": 79,
    "sampleSize": 1954
  },
  "recalls": {
    "total": 6,
    "recent": [
      {
        "resNumber": "Z-0051-2021",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Ansell Healthcare Products LLC",
        "firmAsPublished": "Ansell Healthcare Products LLC",
        "reason": "Examination gloves were shipped inadvertently, without to verify barrier integrity.",
        "initiated": "2020-08-19"
      },
      {
        "resNumber": "Z-0712-2012",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Adenna Inc",
        "firmAsPublished": "Adenna Inc",
        "reason": "The recall was initiated because Adenna Inc.  distributed latex gloves that have been FDA refused.",
        "initiated": "2011-12-22"
      },
      {
        "resNumber": "Z-0909-06",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Gulf South Medical Supply Inc",
        "firmAsPublished": "Gulf South Medical Supply Inc",
        "reason": "FDA's laboratory analysis found holes in the gloves that exceeded the allowable limit. Gloves with holes compromise the integrity of the latex barrier and have the potential to allow hazardous substances to come into contact with the user's skin.",
        "initiated": "2006-04-10"
      },
      {
        "resNumber": "Z-1045-03",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Henry Schein, Inc.",
        "firmAsPublished": "Henry Schein, Inc.",
        "reason": "FDA's analysis revealed defects (holes) in the latex gloves.",
        "initiated": "2003-06-27"
      },
      {
        "resNumber": "Z-1046-03",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Henry Schein, Inc.",
        "firmAsPublished": "Henry Schein, Inc.",
        "reason": "FDA's analysis revealed defects (holes) in the latex gloves.",
        "initiated": "2003-06-27"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K250069",
      "deviceName": "Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein",
      "applicant": "Comfort Rubber Gloves Industries Sdn. Bhd.",
      "company": "Comfort Rubber Gloves Industries Sdn. Bhd.",
      "decisionDate": "2025-04-29",
      "dateReceived": "2025-01-10"
    },
    {
      "kNumber": "K240266",
      "deviceName": "Latex Examination Glove Powder Free (Ocean Blue and Natural White)",
      "applicant": "Sri Trang Gloves (Thailand) Public Company Limited",
      "company": "SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED.",
      "decisionDate": "2024-09-09",
      "dateReceived": "2024-01-31"
    },
    {
      "kNumber": "K230573",
      "deviceName": "Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)",
      "applicant": "Kossan International Sdn Bhd",
      "company": "Kossan International Sdn Bhd",
      "decisionDate": "2023-06-13",
      "dateReceived": "2023-03-01"
    },
    {
      "kNumber": "K223298",
      "deviceName": "Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)",
      "applicant": "Shandong Intco Medical Products Co, Ltd.",
      "company": "Shandong Intco Medical Products Co, Ltd.",
      "decisionDate": "2023-02-22",
      "dateReceived": "2022-10-27"
    },
    {
      "kNumber": "K222612",
      "deviceName": "Powder-Free Latex examination gloves",
      "applicant": "Guangdong Kingfa Sci. & Tech.Co., Ltd.",
      "company": "Guangdong Kingfa Sci. & Tech.Co., Ltd.",
      "decisionDate": "2022-11-25",
      "dateReceived": "2022-08-30"
    },
    {
      "kNumber": "K221667",
      "deviceName": "Non Sterile Powder Free Latex Examination Glove",
      "applicant": "New Era Medicare Sdn. Bhd.",
      "company": "New Era Medicare Sdn. Bhd.",
      "decisionDate": "2022-10-28",
      "dateReceived": "2022-06-08"
    },
    {
      "kNumber": "K222348",
      "deviceName": "JR MEDIC",
      "applicant": "Jr Engineering & Medical Technologies (M) Sdn. Bhd.",
      "company": "Jr Engineering & Medical Technologies (M) Sdn. Bhd.",
      "decisionDate": "2022-10-27",
      "dateReceived": "2022-08-03"
    },
    {
      "kNumber": "K221374",
      "deviceName": "Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)",
      "applicant": "Hebei Titans Hongsen Medical Technology Co., Ltd.",
      "company": "Hebei Titans Hongsen Medical Technology Co., Ltd.",
      "decisionDate": "2022-10-26",
      "dateReceived": "2022-05-12"
    },
    {
      "kNumber": "K222693",
      "deviceName": "Single-use medical latex examination gloves (LG100)",
      "applicant": "Fitone Latex Products Co., Ltd. Guangdong",
      "company": "Fitone Latex Products Co., Ltd. Guangdong",
      "decisionDate": "2022-09-24",
      "dateReceived": "2022-09-06"
    },
    {
      "kNumber": "K221648",
      "deviceName": "Iconic Latex Glove",
      "applicant": "Iconic Medicare Sdn Bhd",
      "company": "Iconic Medicare Sdn Bhd",
      "decisionDate": "2022-08-25",
      "dateReceived": "2022-06-07"
    }
  ],
  "topApplicants": [
    {
      "name": "Wembley Rubber Products (M) Sdn Bhd",
      "count": 37
    },
    {
      "name": "Sgmp Co., Ltd.",
      "count": 25
    },
    {
      "name": "Hartalega Sdn Bhd",
      "count": 19
    },
    {
      "name": "Siam Sempermed Corp., Ltd.",
      "count": 19
    },
    {
      "name": "Perusahaan Getah Asas Sdn. Bhd.",
      "count": 16
    }
  ],
  "topCompanies": [
    {
      "name": "Wembley Rubber Products (M) Sdn Bhd",
      "count": 37,
      "spellings": 1
    },
    {
      "name": "Sgmp Co., Ltd.",
      "count": 25,
      "spellings": 1
    },
    {
      "name": "Hartalega Sdn Bhd",
      "count": 19,
      "spellings": 1
    },
    {
      "name": "Siam Sempermed Corp., Ltd.",
      "count": 19,
      "spellings": 1
    },
    {
      "name": "Perusahaan Getah Asas Sdn. Bhd.",
      "count": 16,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2024-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "LYY (Latex Patient Examination Glove): nothing changed in the six FDA sources we watch.",
    "severity": 1,
    "factors": [],
    "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%3ALYY"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALYY"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALYY"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALYY"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALYY"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALYY"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALYY"
    }
  ],
  "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": "2026-08-11T13:51:45.741Z"
}