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SPECIFICATION (ASTM D6319 & EN 455)
| Dimension | Standard specification | Typical | |
|---|---|---|---|
| Cuff | Min. 0.05 mm | 0.06 mm | 2.0 mil |
| Palm | Min. 0.06 mm | 0.08 mm | 2.4 mil |
| Finger | Min. 0.08 mm | 0.10 mm | 3.9 mil |
| Length | Min. 295 mm | 295 – 300 | |
| Physical properties (Unaged) | Standard specification | Typical |
|---|---|---|
| Tensile strengths | Min. 18 MPa | 28 – 32 |
| Elongation | Min. 500% | 520 – 560 |
| Force at break | Min. 6.0 N | 7.0 – 8.0 |
| Physical properties (Aged) | Standard specification | Typical |
|---|---|---|
| Tensile strengths | Min. 14 MPa | 29 – 33 |
| Elongation | Min. 400% | 520 – 560 |
| Force at break | Min. 6.0 N | 7.5 – 8.5 |
REGULATIONS STANDARD & COMPLIANCE
| GB 4806.11-2016 | MDSAP (US, Canada, Australia) |
| ISO 13485 | MDR (EU) 2017/745 |
| ISO 9001 | PPER (EU) 2016/425 |
| ISO 14001 | U.S FDA 510(k) |
| ISO 45001 |