MEDCHECK許可證索引
衛部醫器輸壹字
許可證編號020569
許可證編號020569
輸入器材
醫療器材許可證 ／ 輸入器材
"康德樂" 普特斯無粉手術用手套 (滅菌)
"Cardinal" Protexis Powder-Free Surgical Gloves (Sterile)
衛部醫器輸壹字第020569號
本站收錄狀態核准有效
有效日期2029 / 06 / 19
醫療器材級數第一等級
申請商為 埃默高有限公司，收錄 23 個 UDI 型號。 以下整理許可證、規格與製造廠資料，供核對產品身分使用。
許可證資料 依公開資料欄位整理
- 許可證字號
- 衛部醫器輸壹字第020569號
- 申請商
- 埃默高有限公司 （查看此申請商全部許可證）
- 統一編號
- 53770631
- 申請商地址
- 新北市新店區北新路3段221號10樓
- 發證日期
- 2019 / 06 / 19
- 有效日期
- 2029 / 06 / 19
- 限制項目
- 輸 入
- 資料異動日期
- 2024 / 02 / 23
這類器材是什麼 手術用手套，AI 輔助整理
手術用手套是動手術、做侵入性處置時戴的醫療手套，主要用來隔開病人和醫護人員的體液、血液。它屬於醫療器材，不是一般打掃用的家事手套。
和一般手套差在哪
最大的差別在「滅菌」和「無粉」這兩個標示。手術用手套直接接觸開放性傷口和無菌區域，出廠前必須經過滅菌處理；一般清潔用手套沒有這個要求。
- 滅菌：包裝上會標示，代表手套本身沒有活的微生物。
- 無粉：早期手套內側撲玉米澱粉方便穿脫，粉末可能刺激組織或影響傷口，現在手術用多為無粉。
- 單次使用：本站收錄的型號裡幾乎全部標示單次使用，用完就丟，不重複滅菌再用。
為什麼多數是乳膠
本站收錄的型號中約 75% 標示含乳膠。乳膠彈性好、貼手、阻隔性佳，是傳統材料。對乳膠過敏的人，醫護端會改用其他材質的手套，這部分由醫療院所依病人狀況選擇。
誰會用到它
- 外科醫師、護理師、助產人員等執行手術或侵入性處置的人員。
- 牙科、急診、檢驗等需要接觸體液的場合。
- 處理病人檢體、傷口換藥等作業。
- 一般人不需要自行購買這類手套，居家清潔用的一般手套就夠。
買的時候怎麼確認合法
包裝上要有醫療器材許可證字號，格式像「衛部醫器製字第○○○○○○號」或「衛部醫器輸字第○○○○○○號」，「製」是國內製造、「輸」是進口。本站收錄 43 張有效許可證，其中 40 張是進口，製造廠以馬來西亞、中國、泰國、美國為主。拿到字號可在本站查是否仍有效。
常見問題
手術用手套可以重複使用嗎？
不行。這類手套幾乎都標示單次使用，用過就丟。重複使用無法確保滅菌狀態，也可能在清洗過程中產生肉眼看不到的破損，失去阻隔效果。
手術用手套和檢查手套一樣嗎？
不完全一樣。兩者都用來隔離體液，但手術用手套的尺寸更貼合、要求更嚴，且一定滅菌；檢查手套有些未滅菌，用於一般檢查。實際用哪一種，由醫療院所依作業性質決定。
對乳膠過敏怎麼辦？
不一定只能用乳膠。乳膠過敏的人可改用其他材質的手套，醫療院所會依人員或病人的過敏史選用。若你已知對乳膠過敏，就醫或接受處置前先告知醫護人員。
哪裡買得到手術用手套？
一般不透過一般零售通路販售，主要由醫療器材商供應給醫療院所。若在網路上看到販售，先確認包裝有醫療器材許可證字號，並留意是否標示滅菌與單次使用。
本段由 AI 依官方分類輔助整理，僅供認識器材之用，不構成醫療建議。使用前請以醫師指示與產品仿單為準。
UDI 標示 依 UDI 資料彙整
- 單次使用是
- 滅菌包裝未填
- 天然橡膠（乳膠）含
- DEHP不含
- 批號有
- 序號無
- 製造日期有
- 有效期限有
- 健保特材未填
這張許可證底下有多個型號時，只要其中一款有標示，就顯示為「是」或「有」。
效能與規格
- 效能
- 限醫療器材分類分級管理辦法「手術用手套(I.4460)」第一等級鑑別範圍。
製造廠
- 製造商
- CARDINAL HEALTH 222 (THAILAND) LTD.
- 國別
- 泰國
- 廠址
- 7/111 MOO 4, HIGHWAY #331, MABYANGPORN, PLUAKDAENG, RAYONG 21140, THAILAND
- 製造許可登錄編號
- QSD8834
- 製造商
- Cardinal Health 200, LLC
- 國別
- 美國
- 廠址
- 3651 Birchwood Drive Waukegan, IL 60085 USA
UDI 型號 共 23 筆
| 基本 DI | 型號 | 產品描述 | 單次使用 | 乳膠 | DEHP |
|---|---|---|---|---|---|
| 10885380019272 | 2D72LU55 | Protexis™ Latex Blue with Neu-Thera™ • Distinct blue color aids in alerting wearers to perforations in the outerglove • Ideal underglove when double-gloving • Designed to be comfortable and reliable for a variety of surgical procedures | 是 | 是 | 否 |
| 10885380019289 | 2D72LU60 | Protexis™ Latex Blue with Neu-Thera™ • Distinct blue color aids in alerting wearers to perforations in the outerglove • Ideal underglove when double-gloving • Designed to be comfortable and reliable for a variety of surgical procedures | 是 | 是 | 否 |
| 10885380019296 | 2D72LU65 | Protexis™ Latex Blue with Neu-Thera™ • Distinct blue color aids in alerting wearers to perforations in the outerglove • Ideal underglove when double-gloving • Designed to be comfortable and reliable for a variety of surgical procedures | 是 | 是 | 否 |
| 10885380019302 | 2D72LU70 | Protexis™ Latex Blue with Neu-Thera™ • Distinct blue color aids in alerting wearers to perforations in the outerglove • Ideal underglove when double-gloving • Designed to be comfortable and reliable for a variety of surgical procedures | 是 | 是 | 否 |
| 10885380019319 | 2D72LU75 | Protexis™ Latex Blue with Neu-Thera™ • Distinct blue color aids in alerting wearers to perforations in the outerglove • Ideal underglove when double-gloving • Designed to be comfortable and reliable for a variety of surgical procedures | 是 | 是 | 否 |
| 10885380019326 | 2D72LU80 | Protexis™ Latex Blue with Neu-Thera™ • Distinct blue color aids in alerting wearers to perforations in the outerglove • Ideal underglove when double-gloving • Designed to be comfortable and reliable for a variety of surgical procedures | 是 | 是 | 否 |
| 10885380019333 | 2D72LU85 | Protexis™ Latex Blue with Neu-Thera™ • Distinct blue color aids in alerting wearers to perforations in the outerglove • Ideal underglove when double-gloving • Designed to be comfortable and reliable for a variety of surgical procedures | 是 | 是 | 否 |
| 10885380019340 | 2D72LU90 | Protexis™ Latex Blue with Neu-Thera™ • Distinct blue color aids in alerting wearers to perforations in the outerglove • Ideal underglove when double-gloving • Designed to be comfortable and reliable for a variety of surgical procedures | 是 | 是 | 否 |
| 10885380031830 | 2D72N60X | Protexis™ Latex Classic • Designed to protect in a broad range of cases • Ideal outer glove when double-gloving, or can be worn as a stand-alone glove • Exceptional protection, dexterity and an advanced grip | 是 | 是 | 否 |
| 10885380031847 | 2D72N65X | Protexis™ Latex Classic • Designed to protect in a broad range of cases • Ideal outer glove when double-gloving, or can be worn as a stand-alone glove • Exceptional protection, dexterity and an advanced grip | 是 | 是 | 否 |
| 10885380031854 | 2D72N70X | Protexis™ Latex Classic • Designed to protect in a broad range of cases • Ideal outer glove when double-gloving, or can be worn as a stand-alone glove • Exceptional protection, dexterity and an advanced grip | 是 | 是 | 否 |
| 10885380031861 | 2D72N75X | Protexis™ Latex Classic • Designed to protect in a broad range of cases • Ideal outer glove when double-gloving, or can be worn as a stand-alone glove • Exceptional protection, dexterity and an advanced grip | 是 | 是 | 否 |
| 10885380031878 | 2D72N80X | Protexis™ Latex Classic • Designed to protect in a broad range of cases • Ideal outer glove when double-gloving, or can be worn as a stand-alone glove • Exceptional protection, dexterity and an advanced grip | 是 | 是 | 否 |
| 10885380031885 | 2D72N85X | Protexis™ Latex Classic • Designed to protect in a broad range of cases • Ideal outer glove when double-gloving, or can be worn as a stand-alone glove • Exceptional protection, dexterity and an advanced grip | 是 | 是 | 否 |
| 10885380031892 | 2D72N90X | Protexis™ Latex Classic • Designed to protect in a broad range of cases • Ideal outer glove when double-gloving, or can be worn as a stand-alone glove • Exceptional protection, dexterity and an advanced grip | 是 | 是 | 否 |
| 10885380031915 | 2D72PT55X | Protexis™ PI • Designed to be comfortable and reliable for a variety of surgical procedures • Our most popular glove in the U.S. • Synthetic polyisoprene, not made with natural rubber latex | 是 | 否 | 否 |
| 10885380031922 | 2D72PT60X | Protexis™ PI • Designed to be comfortable and reliable for a variety of surgical procedures • Our most popular glove in the U.S. • Synthetic polyisoprene, not made with natural rubber latex | 是 | 否 | 否 |
| 10885380031939 | 2D72PT65X | Protexis™ PI • Designed to be comfortable and reliable for a variety of surgical procedures • Our most popular glove in the U.S. • Synthetic polyisoprene, not made with natural rubber latex | 是 | 否 | 否 |
| 10885380031946 | 2D72PT70X | Protexis™ PI • Designed to be comfortable and reliable for a variety of surgical procedures • Our most popular glove in the U.S. • Synthetic polyisoprene, not made with natural rubber latex | 是 | 否 | 否 |
| 10885380031953 | 2D72PT75X | Protexis™ PI • Designed to be comfortable and reliable for a variety of surgical procedures • Our most popular glove in the U.S. • Synthetic polyisoprene, not made with natural rubber latex | 是 | 否 | 否 |
| 10885380031960 | 2D72PT80X | Protexis™ PI • Designed to be comfortable and reliable for a variety of surgical procedures • Our most popular glove in the U.S. • Synthetic polyisoprene, not made with natural rubber latex | 是 | 否 | 否 |
| 10885380031977 | 2D72PT85X | Protexis™ PI • Designed to be comfortable and reliable for a variety of surgical procedures • Our most popular glove in the U.S. • Synthetic polyisoprene, not made with natural rubber latex | 是 | 否 | 否 |
| 10885380031984 | 2D72PT90X | Protexis™ PI • Designed to be comfortable and reliable for a variety of surgical procedures • Our most popular glove in the U.S. • Synthetic polyisoprene, not made with natural rubber latex | 是 | 否 | 否 |
找的不是這個型號？
可改用包裝上的完整型號或許可證字號查詢。