{
  "code": "LYZ",
  "deviceName": "Vinyl Patient Examination Glove",
  "deviceClass": "I",
  "regulationNumber": "880.6250",
  "panel": "General Hospital",
  "definition": "A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) 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": 799,
    "last12Months": 3
  },
  "adverseEvents": {
    "total": 3,
    "last12Months": 0
  },
  "reviewDays": {
    "median": 70,
    "sampleSize": 799
  },
  "recalls": {
    "total": 7,
    "recent": [
      {
        "resNumber": "Z-2828-2018",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Cypress Medical Products, Ltd.",
        "firmAsPublished": "Cypress Medical Products LLC",
        "reason": "The firm is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because a sample of product from that lot did not meet certain release specifications. It is possible that certain gloves from this lot may not be of medical exam quality and, therefore, may not provide an effective barrier to infectious material.",
        "initiated": "2018-07-02"
      },
      {
        "resNumber": "Z-0741-2017",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Cypress Medical Products, Ltd.",
        "firmAsPublished": "CYPRESS MEDICAL PRODUCTS",
        "reason": "A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.",
        "initiated": "2016-10-12"
      },
      {
        "resNumber": "Z-0295-2013",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Gulf South Medical Supply Inc",
        "firmAsPublished": "Gulf South Medical Supply Inc",
        "reason": "Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale.",
        "initiated": "2012-06-20"
      },
      {
        "resNumber": "Z-0679-2012",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Cypress Medical Products, Ltd.",
        "firmAsPublished": "Cypress Medical Products LLC",
        "reason": "The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.",
        "initiated": "2011-11-15"
      },
      {
        "resNumber": "Z-0680-2012",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Cypress Medical Products, Ltd.",
        "firmAsPublished": "Cypress Medical Products LLC",
        "reason": "The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.",
        "initiated": "2011-11-15"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260860",
      "deviceName": "Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)",
      "applicant": "Basic Medical Technology, Inc.",
      "company": "Basic Medical Technology, Inc.",
      "decisionDate": "2026-04-07",
      "dateReceived": "2026-03-16"
    },
    {
      "kNumber": "K252467",
      "deviceName": "Disposable Vinyl Examination Gloves",
      "applicant": "Viet Phu Trade and Import Export Co., Ltd.",
      "company": "Viet Phu Trade and Import Export Co., Ltd.",
      "decisionDate": "2025-10-27",
      "dateReceived": "2025-08-06"
    },
    {
      "kNumber": "K252505",
      "deviceName": "Powder-Free Vinyl Exam Gloves, clear",
      "applicant": "Basic Medical Technology, Inc.",
      "company": "Basic Medical Technology, Inc.",
      "decisionDate": "2025-08-28",
      "dateReceived": "2025-08-08"
    },
    {
      "kNumber": "K241252",
      "deviceName": "Disposable Vinyl Examination Gloves",
      "applicant": "Anqing Pukang Medical Technology Co., Ltd.",
      "company": "Anqing Pukang Medical Technology Co., Ltd.",
      "decisionDate": "2024-05-20",
      "dateReceived": "2024-05-03"
    },
    {
      "kNumber": "K230046",
      "deviceName": "Vinyl examination gloves",
      "applicant": "Guangdong Kingfa Sci. & Tech.Co., Ltd.",
      "company": "Guangdong Kingfa Sci. & Tech.Co., Ltd.",
      "decisionDate": "2023-03-25",
      "dateReceived": "2023-01-06"
    },
    {
      "kNumber": "K221980",
      "deviceName": "Disposable Powder Free Vinyl Examination Gloves, Beige/Clear",
      "applicant": "Ever Global (Vietnam) Enterprise Corporation",
      "company": "Ever Global (Vietnam) Enterprise Corporation",
      "decisionDate": "2023-02-06",
      "dateReceived": "2022-07-05"
    },
    {
      "kNumber": "K220992",
      "deviceName": "Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple",
      "applicant": "Ever Global (Vietnam) Enterprise Corporation",
      "company": "Ever Global (Vietnam) Enterprise Corporation",
      "decisionDate": "2022-10-19",
      "dateReceived": "2022-04-04"
    },
    {
      "kNumber": "K223008",
      "deviceName": "Disposable Vinyl Examination Gloves",
      "applicant": "Jiangxi Handspro Products Solutions Co., Ltd.",
      "company": "Jiangxi Handspro Products Solutions Co., Ltd.",
      "decisionDate": "2022-10-08",
      "dateReceived": "2022-09-29"
    },
    {
      "kNumber": "K222442",
      "deviceName": "DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)",
      "applicant": "Anhui Bytech Medical Supplies Co., Ltd.",
      "company": "Anhui Bytech Medical Supplies Co., Ltd.",
      "decisionDate": "2022-09-28",
      "dateReceived": "2022-08-12"
    },
    {
      "kNumber": "K220055",
      "deviceName": "Disposable, vinyl examination gloves, Yellow",
      "applicant": "Dezhou Hengchang Medical Technology Co., Ltd.",
      "company": "Dezhou Hengchang Medical Technology Co., Ltd.",
      "decisionDate": "2022-08-25",
      "dateReceived": "2022-01-06"
    }
  ],
  "topApplicants": [
    {
      "name": "Shanghai Antares Industries, Inc.",
      "count": 14
    },
    {
      "name": "Bd Becton Dickinson Vacutainer Systems Preanalytic",
      "count": 13
    },
    {
      "name": "Ever Light Plastic Products Co., Ltd.",
      "count": 11
    },
    {
      "name": "Grand Work Plastic Products Co., Ltd.",
      "count": 11
    },
    {
      "name": "Shanghai Palomar Mountain Industries, Inc.",
      "count": 10
    }
  ],
  "topCompanies": [
    {
      "name": "Shanghai Antares Industries, Inc.",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "Bd Becton Dickinson Vacutainer Systems Preanalytic",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Ever Light Plastic Products Co., Ltd.",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Grand Work Plastic Products Co., Ltd.",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Shanghai Palomar Mountain Industries, Inc.",
      "count": 10,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Viet Phu Trade and Import Export Co., Ltd.",
      "since": "2025-10-27",
      "kNumber": "K252467"
    },
    {
      "name": "Basic Medical Technology, Inc.",
      "since": "2025-08-28",
      "kNumber": "K252505"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2024-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "LYZ (Vinyl Patient Examination Glove) has two findings, most consequential first. 2 first-time filers in the last 12 months, Viet Phu Trade and Import Export Co., Ltd. and Basic Medical Technology, Inc (K252467, K252505). The code is crowded, scoring 81 of 100 — 413 companies hold a clearance here and 3 arrived in the last 12 months (LYZ:crowding).",
    "severity": 42,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, Viet Phu Trade and Import Export Co., Ltd. and Basic Medical Technology, Inc.",
        "recordIds": [
          "K252467",
          "K252505"
        ],
        "severity": 42
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 81 of 100 — 413 companies hold a clearance here and 3 arrived in the last 12 months",
        "recordIds": [
          "LYZ: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%3ALYZ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALYZ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALYZ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALYZ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALYZ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALYZ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALYZ"
    }
  ],
  "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"
}