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SPECIFICATION (ASTM D6319 & EN 455)
| Dimension | Standard specification | Typical | |
|---|---|---|---|
| Cuff | Min. 0.08 mm | 0.09 mm | 3.5 mil |
| Palm | Min. 0.10 mm | 0.11 mm | 4.3 mil |
| Finger | Min. 0.12 mm | 0.15 mm | 5.9 mil |
| Length | Min. 240 mm | 240 – 245 | |
| Physical properties (Unaged) | Standard specification | Typical |
|---|---|---|
| Tensile strengths | Min. 18 MPa | 24 – 28 |
| Elongation | Min. 500% | 520 – 580 |
| Force at break | Min. 6.0 N | 8.0 – 9.0 |
| Physical properties (Aged) | Standard specification | Typical |
|---|---|---|
| Tensile strengths | Min. 14 MPa | 26 – 30 |
| Elongation | Min. 400% | 520 – 580 |
| Force at break | Min. 6.0 N | 8.0 – 9.0 |
REGULATIONS STANDARD & COMPLIANCE
| ISO 13485 | MDSAP (US, Canada, Australia) |
| ISO 9001 | MDR (EU) 2017/745 |
| ISO 14001 | PPER (EU) 2016/425 |
| ISO 45001 | U.S FDA 510(k) |