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SPECIFICATION (ASTM D6319 & EN 455)
| Dimension | Standard specification | Typical | |
|---|---|---|---|
| Cuff | Min. 0.09 mm | 0.12 mm | 4.7 mil |
| Palm | Min. 0.14 mm | 0.18 mm | 7.1 mil |
| Finger | Min. 0.19 mm | 0.23 mm | 9.1 mil |
| Length | Min. 295 mm | 295 – 300 | |
| Physical properties (Unaged) | Standard specification | Typical |
|---|---|---|
| Tensile strengths | Min. 18 MPa | 24 – 28 |
| Elongation | Min. 500% | 540 – 580 |
| Force at break | Min. 6.0 N | 14 – 16 |
| Physical properties (Aged) | Standard specification | Typical |
|---|---|---|
| Tensile strengths | Min. 14 MPa | 26 – 30 |
| Elongation | Min. 400% | 520 – 560 |
| Force at break | Min. 6.0 N | 15 – 17 |
REGULATIONS STANDARD & COMPLIANCE
| AS/NZS 4011 | ISO 45001 |
| GB 4806.11-2016 | MDSAP (US, Canada, Australia) |
| ISO 11193-1 | MDR (EU) 2017/745 |
| ISO 13485 | PPER (EU) 2016/425 |
| ISO 9001 | U.S FDA 510(k) |
| ISO 14001 |