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SPECIFICATION (ASTM D6319 & EN 455)
| Dimension | Standard specification | Typical | |
|---|---|---|---|
| Cuff | Min. 0.09 mm | 0.10 mm | 3.9 mil |
| Palm | Min. 0.11 mm | 0.13 mm | 5.1 mil |
| Finger | Min. 0.14 mm | 0.16 mm | 6.3 mil |
| Length | Min. 240 mm | 240 – 245 | |
| Physical properties (Unaged) | Standard specification | Typical |
|---|---|---|
| Tensile strengths | Min. 18 MPa | 22 – 26 |
| Elongation | Min. 650% | 700 – 740 |
| Force at break | Min. 6.0 N | 8.0 – 8.5 |
| Physical properties (Aged) | Standard specification | Typical |
|---|---|---|
| Tensile strengths | Min. 14 MPa | 18 – 22 |
| Elongation | Min. 500% | 620 – 660 |
| Force at break | Min. 6.0 N | 8.0 – 8.5 |
REGULATIONS STANDARD & COMPLIANCE
| AS/NZS 4011 | ISO 45001 |
| ISO 11193-1 | MDSAP (US, Canada, Australia) |
| ISO 13485 | MDR (EU) 2017/745 |
| ISO 9001 | U.S. FDA 510(k) |
| ISO 14001 | |