The Vasco® OP free is a polyisoprene surgical glove with a rolled cuff (AQL value 0.65). It is certified as a medical device of Class IIa according to MDD 93/42/EEC and bears the CE mark 0123, issued by TÜV Süd in Germany. The gloves meet the requirements of EN 455 1-4 as well as ISO standards 10282, 10993, and 11137. Additionally, they are classified as personal protective equipment of Category III according to 89/686/EEC (CE 0321, SATRA, UK). The gloves comply with additional standards such as EN 420, EN 374 1-3, EN 16523, and EN 388, and have been tested according to ASTM standards F1671, D6978, D3577, and D5712.