市售醫用手套之品質監測   全文下載

Investigation of Watertightness and Aqueous Extractable Protein Content of Medical Gloves in Taiwan

為瞭解市售醫用手套之品質，本計畫委請地方政府衛生局於105年1至6月間，至醫療器材行、醫療院所及許可證持有藥商等地進行抽樣，共計抽得第1等級醫用手套16件及第2等級醫用手套4件，總計20件，依醫用手套材質分類，則有橡膠9件、polyvinylchloride10件及Polyethylene1件。分別參考99年9月30日署授食字第0991612765號公告之「含粉手術用手套」醫療器材臨床前測試基準、ASTMD5250、ASTMD3577、ASTMD3578等公認標準進行水密性試驗，另參考ASTMD5712針對橡膠材質手套進行水溶性蛋白試驗。檢測結果20件市售檢體在水密性試驗部分，有17件符合標準要求。9件橡膠材質醫用手套其水溶性蛋白含量皆未超過標準上限。本次調查結果，可供行政管理單位作為產品管理之參考依據。

In order to assure the quality of medical gloves available on the market, a survey focused on the watertightness performance and the aqueous extractable protein content of the medical gloves was conducted in 2016. From January to June, 20 samples were collected by the local health authorities from hospitals, authorized dealers and drug stores. Among them, 16 are class I medical gloves and the others are class II. The materials range from rubber, polyvinyl chloride to polyethylene. The watertightness test was carried out in accordance with ASTM D3577, ASTM D3578 and ASTM D5250. The aqueous extractable proteins in the rubber gloves were tested and content levels were determined in accordance to ASTM D5712. The results showed that 17 samples met the watertightness requirement while all the 9 rubber medical gloves tested for their aqueous extractable proteins fulfilled the regulatory requirement (below 200 μg/dm2). These results will be forwarded to the competent authorities as regulatory references.