市售醫用手套之品質監測   全文下載

Investigation of Watertightness and Residual Powder of Medical Gloves in Taiwan

為了解市售醫用手套之品質，本計畫委請地方政府衛生局於107年1月至6月間，至醫療器材行、醫療院所、藥局及大賣場等地進行抽樣，共計抽得第1等級手套27件及第2等級含粉手術用手套3件，總計30件，依手套材質分類，則有聚氯乙烯16件、乳膠10件、丁腈橡膠3件及聚乙烯1件；而依手套用途則有26件為病患檢查用手套，4件為手術用手套。檢體分別參考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、原廠規格及ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves等進行水密性試驗及殘粉試驗之安全效能評估。檢測結果30件檢體在水密性試驗部分，有29件符合廠規要求。而殘粉試驗的背景值調查結果，21件無粉醫用手套，檢測結果皆符合ASTM規範。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。

To ensure the quality of medical gloves available on the market, a survey focused on the watertightness performance and the residual powder of the medical gloves was conducted in 2018. From January to June, 30 samples were collected from hospitals, authorized dealers and drug stores by the local health authorities. Among them, 27 are class I medical gloves and the other 3 are class II. The materials include rubber, polyvinyl chloride, and polyethylene. The watertightness test was carried out in accordance with ASTM D3577, ASTM D3578 and ASTM D5250. The residual powders in the medical gloves were tested under ASTM D6124. The results showed that 29 samples met the watertightness requirement and all the 21 samples of powder-free medical gloves tested for their residual powder fulfilled the ASTM requirement (below 2.0 mg/glove). These results will be forwarded to the competent authorities as regulatory references.