nitrile gloves
by Shandong Intco Medical Products Co., Ltd. 9 variants
Ref MV-GDNIT-NE-DLSP, SI-NITRILO-ST-M, KR-GDNIT-NE-50SP, QSCHNCZL005, SI-NITRILO-T-NE-M, KR-GDNIT-AZ-50SP, QSCHNCZS007, QSCHNNXL003, MV-GDNIT-AZ-DLSP, KR-GDNIT-AZ-DLSP, SI-NITRILO-ST, QSCHNCZM006
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 | Number697024575Nitrile7G | Date23 Aug 2023 | StatusActive |
Certificates
No certifier 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- Withdrawn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 Nitrile Examination Gloves, Powder Free
- Model / Reference
- MV-GDNIT-NE-DLSP, SI-NITRILO-ST-M, KR-GDNIT-NE-50SP, QSCHNCZL005, SI-NITRILO-T-NE-M, KR-GDNIT-AZ-50SP, QSCHNCZS007, QSCHNNXL003, MV-GDNIT-AZ-DLSP, KR-GDNIT-AZ-DLSP, SI-NITRILO-ST, QSCHNCZM006
- Primary DI / UDI-DI
- 06978719510308, 06978719510803, 06978719510650, 06970245750463, 06978719510841, 06978719510780, 06978719510629, 06978719510766, 06978719510797, 06978719510612, 06978719510810, 06970245750449, 06970245750432, 06978719510278, 06978719510230, 06978719510551, 06978719511107, 06978719510865, 06978719510667, 06978719510858, 06978719510636, 06970245750456, 06978719510575, 06978719511169, 06978719510315, 06978719511114, 06978719510322, 06978719510544, 06978719510285, 06978719510834, 06978719510599, 06978719511121, 06978719510292, 06978719510520, 06978719511152, 06978719510223, 06978719510339, 06978719510681, 06978719510872, 06978719510582, 06978719510605, 06978719510827, 06978719510773
- Basic UDI-DI
- 697024575Nitrile7G
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000002100
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Shandong Intco Medical Products Co., Ltd.
See all devices from Shandong Intco Medical Products Co., Ltd. →
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