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Apron, Leaded（EAJ）
鉛防護用エプロン この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。
25 件
直近 2019.08.07
6 件
0 件
114 件
分類情報
| Product Code | EAJ |
|---|---|
| デバイス名 | Apron, Leaded 鉛防護用エプロン この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。 |
| デバイスクラス | クラス I |
| 21 CFR 規制番号 | 892.6500 |
| 審査区分 | 届出免除（510(k) Exempt） |
| 医療専門分野 | 放射線科 |
| 定義 | － |
| フラグ | 該当なし |
| AI分析 | 本品は、放射線診療時に医療従事者や患者の身体を放射線被曝から保護するために使用される鉛入りのエプロンです。米国ではクラスIに分類され、市販前届出（510(k)）が免除される医療機器として扱われており、市販前に安全性・有効性を個別審査されることなく流通が認められています。 米国市場での動向 510(k)は累計約6件で、参入企業は5社、直近5年の届出は確認されていません（最新判定は1993年6月です）。PMAの実績はありません。不具合報告は累計約110件で、その大半がMalfunction（不具合）であり、死亡1件、傷害約8件が含まれています。主な問題として汚染／除染の問題（Contamination/Decontamination Problem）、機器または機器部品の脱落（Detachment of Device or Device Component）、意図しない動き（Unintended Movement）が挙げられています。回収は累計25件でいずれもクラスIIに区分され、クラスIおよびクラスIIIは確認されておらず、直近5年の回収はなく最新の回収開始は2019年6月です。 この分析は公開データ（openFDA・JMDN 対応情報）をもとに AI が生成した参考情報です。市場データは2026年8月時点の集計に基づきます。 |
関連 product code
同じ 21 CFR 892.6500 に分類される product code（10 件）
| No. | product code | 機器名 | クラス | 専門分野 | 510(k) | PMA | 不具合 | 回収 |
|---|---|---|---|---|---|---|---|---|
| 1 | KPY | Shield, Protective, Personnel 個人用防護シールド | I | 放射線科 | 25 | — | 62 | 2 件 |
| 2 | EAK | Screen, Leaded, Operator Radiation Protector 術者用鉛防護スクリーン | I | 放射線科 | 7 | — | 10 | — |
| 3 | IWS | Shield, Eye, Radiological 放射線用眼遮蔽具 | I | 放射線科 | 6 | — | 4 | — |
| 4 | IWP | Radiographic Protective Glove 放射線防護用手袋 | I | 放射線科 | 5 | — | 6 | — |
| 5 | IWR | Holder, Syringe, Lead 注射器・鉛遮蔽ホルダー | I | 放射線科 | 4 | — | 1 | — |
| 6 | IWQ | Curtain, Protective, Radiographic 放射線防護用カーテン | I | 放射線科 | 3 | — | 11 | — |
| 7 | IWX | Barrier, Control Panel, X-Ray, Movable 移動型X線操作卓用防護バリア | I | 放射線科 | 3 | — | 1 | 1 件 |
| 8 | IWT | Shield, Gonadal 性腺遮蔽具 | I | 放射線科 | 2 | — | — | — |
| 9 | IWO | Apron, Protective 防護用エプロン | I | 放射線科 | 1 | — | 4 | 13 件 |
| 10 | IWW | Shield, Vial バイアル用防護シールド | I | 放射線科 | 1 | — | 2 | — |
機器名の日本語訳は AI により自動生成したものです。正確には英語原文をご確認ください。
FDA のデバイスクラスは 3 段階（クラス I〜III）、日本の医療機器は 4 段階（クラス I〜IV）で分類されており、 1 対 1 では対応しません。 リスク区分の考え方が異なるため、参考情報としてご利用ください。
米国での回収・承認・不具合報告
米国回収
全 25 件| 回収番号 | クラス | 回収開始日 | 企業 | 理由 | ステータス |
|---|---|---|---|---|---|
| Z-2130-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2129-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2128-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2127-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2126-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2125-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2124-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2123-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2122-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2121-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2120-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2119-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2118-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2117-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2116-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2115-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2114-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2113-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2112-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
| Z-2111-2019 EAJ | クラス II | 2019.06.07 | Burlington Medical, LLC | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions. | 終了 |
510(k)（市販前届出）
全 6 件| No. | 番号 | 機器名 | 申請者 | 決定日 | 種別 | 概要 |
|---|---|---|---|---|---|---|
| 1 | K931269 | LEAD APRON | Bt Medical Co., Inc. | 1993.06.02 | 通常（Traditional） | － |
| 2 | K913621 | RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR | Rinn Dental Products | 1991.09.27 | 通常（Traditional） | － |
| 3 | K870563 | X-RAY APRON | X-Tech, Ltd. | 1987.02.19 | 通常（Traditional） | － |
| 4 | K870103 | LEAD APRON CADDY | Orthopedic Systems, Inc. | 1987.01.21 | 通常（Traditional） | － |
| 5 | K832602 | THYROID PROTECTIVE COLLAR | E.M. Adams | 1983.09.29 | 通常（Traditional） | － |
| 6 | K832601 | LEADED X-RAY APRON | E.M. Adams | 1983.09.29 | 通常（Traditional） | － |
出典の openFDA は各 510(k) の主要（primary）product code のみを収録しているため、副次コードを含む FDA 公式データベースの検索結果とは件数が異なる場合があります。 FDA 510(k) データベースで確認
PMA（市販前承認）
この product code の PMA 情報はありません。
不具合報告（MAUDE）トレンド
米国不具合報告検索で詳しく見る出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
報告の存在は、機器と事象の因果関係を意味しません。報告件数を機器間の不具合発生率の比較に用いることはできません。
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。
出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
取得日: 2026.09.28
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。