Disposable surgical gloves
by Shandong Ruyue Medical Technology Co., Ltd.
Ref latex-5.0Model latex-5.0, latex-5.5, latex-6, latex-6.5, latex-7, latex-7.5, latex-8, latex-8.5, latex-9, latex-9.5, nitrile-5.0, nitrile-5.5, nitrile-6, nitrile-6.5, nitrile-7, nitrile-7.5, nitrile-8, nitrile-8.5, nitrile-9, etc
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697357642DSG001LE | Date18 Jun 2024 | StatusActive |
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable surgical gloves
- Model / Reference
- latex-5.0, latex-5.5, latex-6, latex-6.5, latex-7, latex-7.5, latex-8, latex-8.5, latex-9, latex-9.5, nitrile-5.0, nitrile-5.5, nitrile-6, nitrile-6.5, nitrile-7, nitrile-7.5, nitrile-8, nitrile-8.5, nitrile-9, etc
- Primary DI / UDI-DI
- 06973576423006
- Basic UDI-DI
- 697357642DSG001LE
- EMDN Code
- T010299 Examination / treatment gloves - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000041139
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shandong Ruyue Medical Technology Co., Ltd
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No