nitrile gloves
by Anhui Intco Medical Products Co., Ltd 8 variants
Ref 393060, 393059, LM-GDNIT-AZ-DLSP, BNXL11, INTNBE10016, CU-GDNIT-AZ-XLSP, 393061, 393056, 393058, 393062, INTNBE10018, INTNBE10013, INTNBE10015, 393057, BNXS07
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 | Number697306977NitrileFR | Date25 Nov 2022 | 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- Withdrawn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
- Trade Name
- nitrile glovesNitrile Gloves Powder Free
- Device Name
- Disposable Nitrile Examination Gloves, Powder Free
- Model / Reference
- 393060, 393059, LM-GDNIT-AZ-DLSP, BNXL11, INTNBE10016, CU-GDNIT-AZ-XLSP, 393061, 393056, 393058, 393062, INTNBE10018, INTNBE10013, INTNBE10015, 393057, BNXS07
- Primary DI / UDI-DI
- 06932400707224, 06932400707156, 06932400710637, 06932400712150, 06932400713706, 06932400707217, 06932400710606, 06932400707293, 06932400707026, 06932400707149, 06932400707170, 06932400707347, 06932400707231, 06932400713720, 06932400713676, 06932400713690, 06932400707071, 06932400712112, 06932400707286, 06932400707279, 06932400707323, 06932400707194, 06932400707125, 06932400707248, 06932400707309, 06932400707064, 06932400707101
- Basic UDI-DI
- 697306977NitrileFR
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- EU market of registration
- AustriaSpain
Manufacturer details
- EUDAMED SRN
- CN-MF-000002356
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Anhui Intco Medical Products Co., Ltd
See all devices from Anhui 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