Gloveon Victor Outer Glove (Amabilia Medical Ab)
by Hartalega NGC Sdn. Bhd. 4 variants
Ref SPI2860, SPI2885, SPI2870, SPI2865, SPI2875Model Polyisoprene Powder Free Surgical Outergloves
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955100777HNGCTFMD010X7 | Date23 Dec 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Polyisoprene Surgical Gloves
- Model / Reference
- Polyisoprene Powder Free Surgical Outergloves, SPI2860, SPI2885, SPI2870, SPI2865, SPI2875
- Primary DI / UDI-DI
- 09551025944332, 09551025944387, 09551025944356, 09551025944349, 09551025944363
- Basic UDI-DI
- 955100777HNGCTFMD010X7
- EMDN Code
- T01010203 Polyisopren surgical gloves
- Device Class
- Class IIa
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- MY-MF-000010459
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Hartalega Ngc Sdn. Bhd.
Properties
Other properties (12)
- 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