{
  "code": "LZA",
  "deviceName": "Polymer Patient Examination Glove",
  "deviceClass": "I",
  "regulationNumber": "880.6250",
  "panel": "General Hospital",
  "definition": "A  nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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": 1175,
    "last12Months": 15
  },
  "adverseEvents": {
    "total": 191,
    "last12Months": 56
  },
  "reviewDays": {
    "median": 94,
    "sampleSize": 1175
  },
  "recalls": {
    "total": 7,
    "recent": [
      {
        "resNumber": "Z-1381-2021",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "HUBO INTERNATIONAL INC",
        "firmAsPublished": "HUBO INTERNATIONAL INC",
        "reason": "Package labeled as nitrile gloves, contains latex gloves.",
        "initiated": "2020-10-23"
      },
      {
        "resNumber": "Z-1283-2019",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Cardinal Health 200, LLC",
        "firmAsPublished": "Cardinal Health 200, LLC",
        "reason": "Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap",
        "initiated": "2019-03-22"
      },
      {
        "resNumber": "Z-1284-2019",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Cardinal Health 200, LLC",
        "firmAsPublished": "Cardinal Health 200, LLC",
        "reason": "Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap",
        "initiated": "2019-03-22"
      },
      {
        "resNumber": "Z-1285-2019",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Cardinal Health 200, LLC",
        "firmAsPublished": "Cardinal Health 200, LLC",
        "reason": "Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap",
        "initiated": "2019-03-22"
      },
      {
        "resNumber": "Z-1286-2019",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Cardinal Health 200, LLC",
        "firmAsPublished": "Cardinal Health 200, LLC",
        "reason": "Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap",
        "initiated": "2019-03-22"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K262014",
      "deviceName": "PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves",
      "applicant": "O&M Halyard, Inc.",
      "company": "O&M Halyard, Inc.",
      "decisionDate": "2026-07-21",
      "dateReceived": "2026-06-15"
    },
    {
      "kNumber": "K254285",
      "deviceName": "Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue",
      "applicant": "Hartalega NGC Sdn. Bhd.",
      "company": "Hartalega NGC Sdn. Bhd.",
      "decisionDate": "2026-07-20",
      "dateReceived": "2025-12-31"
    },
    {
      "kNumber": "K252117",
      "deviceName": "Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution",
      "applicant": "Sw Technologies, Inc.",
      "company": "Sw Technologies, Inc.",
      "decisionDate": "2026-06-24",
      "dateReceived": "2025-07-07"
    },
    {
      "kNumber": "K253824",
      "deviceName": "Powder Free Nitrile Examination Gloves Non-Sterile Black",
      "applicant": "Kanglongda Vietnam Protection Technology Company Limited",
      "company": "Kanglongda Vietnam Protection Technology Company Limited",
      "decisionDate": "2026-06-18",
      "dateReceived": "2025-12-01"
    },
    {
      "kNumber": "K260867",
      "deviceName": "Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)",
      "applicant": "Hartalega NGC Sdn. Bhd.",
      "company": "Hartalega NGC Sdn. Bhd.",
      "decisionDate": "2026-06-17",
      "dateReceived": "2026-03-17"
    },
    {
      "kNumber": "K260806",
      "deviceName": "Nitrile Disposable Examination Gloves",
      "applicant": "Vista Industries,, LLC",
      "company": "Vista Industries,, LLC",
      "decisionDate": "2026-06-03",
      "dateReceived": "2026-03-12"
    },
    {
      "kNumber": "K260703",
      "deviceName": "Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl",
      "applicant": "S&S Glove Corporation",
      "company": "S&S Glove Corporation",
      "decisionDate": "2026-06-03",
      "dateReceived": "2026-03-04"
    },
    {
      "kNumber": "K253160",
      "deviceName": "Syntex Exam Gloves",
      "applicant": "Basic Medical Technology, Inc.",
      "company": "Basic Medical Technology, Inc.",
      "decisionDate": "2026-01-23",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K252549",
      "deviceName": "Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid",
      "applicant": "Kossan International Sdn Bhd",
      "company": "Kossan International Sdn Bhd",
      "decisionDate": "2026-01-13",
      "dateReceived": "2025-08-13"
    },
    {
      "kNumber": "K251141",
      "deviceName": "Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate",
      "applicant": "Mercator Medical (Thailand), Ltd.",
      "company": "Mercator Medical (Thailand), Ltd.",
      "decisionDate": "2025-11-17",
      "dateReceived": "2025-04-14"
    }
  ],
  "topApplicants": [
    {
      "name": "Hartalega Sdn Bhd",
      "count": 33
    },
    {
      "name": "Hartalega NGC Sdn. Bhd.",
      "count": 24
    },
    {
      "name": "Shen Wei (Usa), Inc.",
      "count": 19
    },
    {
      "name": "Siam Sempermed Corp., Ltd.",
      "count": 17
    },
    {
      "name": "Smart Glove Corp. Sdn Bhd",
      "count": 16
    }
  ],
  "topCompanies": [
    {
      "name": "Shen Wei (Usa), Inc.",
      "count": 34,
      "spellings": 2
    },
    {
      "name": "Hartalega Sdn Bhd",
      "count": 33,
      "spellings": 1
    },
    {
      "name": "Hartalega NGC Sdn. Bhd.",
      "count": 24,
      "spellings": 1
    },
    {
      "name": "Smart Glove Corporation Sdn. Bhd.",
      "count": 19,
      "spellings": 2
    },
    {
      "name": "Siam Sempermed Corp., Ltd.",
      "count": 17,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Sw Technologies, Inc.",
      "since": "2026-06-24",
      "kNumber": "K252117"
    },
    {
      "name": "Vista Industries,, LLC",
      "since": "2026-06-03",
      "kNumber": "K260806"
    },
    {
      "name": "Program Insite, LLC",
      "since": "2025-10-17",
      "kNumber": "K252075"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 8,
        "expectedLow": 0,
        "expectedHigh": 16.74068099504425,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 10,
        "expectedLow": 0,
        "expectedHigh": 18.685838023364738,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 2,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "LZA (Polymer Patient Examination Glove) has three findings, most consequential first. 3 first-time filers in the last 12 months, including Sw Technologies, Inc. and Vista Industries,, LLC (K252117, K260806, K252075). Clearances are running 27% slower — a median 119 days over the last 12 months against 94 days all-time (elapsed calendar days, not FDA review days) (LZA:review_time:12m). The code is crowded, scoring 94 of 100 — 488 companies hold a clearance here and 15 arrived in the last 12 months (LZA:crowding).",
    "severity": 43,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Sw Technologies, Inc. and Vista Industries,, LLC",
        "recordIds": [
          "K252117",
          "K260806",
          "K252075"
        ],
        "severity": 43
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 27% slower — a median 119 days over the last 12 months against 94 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "LZA:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 94 of 100 — 488 companies hold a clearance here and 15 arrived in the last 12 months",
        "recordIds": [
          "LZA: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%3ALZA"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALZA"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALZA"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALZA"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALZA"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALZA"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALZA"
    }
  ],
  "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": "2026-08-11T13:51:45.742Z"
}