GentleSafe Nitrile Extra
by DACH Schutzbekleidung GmbH & Co. KG
Ref 873/XL, 883/BK/L, 883/B/M, 883/BK/S, 873/S, 883/B/S, 883/BK/M, 873/M, 873/LModel Medical Gloves
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 | Number4049825GLOVESYE | Date28 Feb 2024 | 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- Withdrawn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
- GentleSafe Nitrile ExtraGentleSafe Nitrile
- Model / Reference
- Medical Gloves, 873/XL, 883/BK/L, 883/B/M, 883/BK/S, 873/S, 883/B/S, 883/BK/M, 873/M, 873/L
- Primary DI / UDI-DI
- 04049825002109, 04049825007715, 04049825007623, 04049825007692, 04049825002079, 04049825007616, 04049825007708, 04049825002086, 04049825002093
- Basic UDI-DI
- 4049825GLOVESYE
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000014734
Other devices from DACH Schutzbekleidung GmbH & Co. KG
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