SuperGuard ( Black Nitrile )
by Maxwell Glove Manufacturing Berhad 4 variants
Ref S, L, XS, M, XL
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 | Number955558600248LK | Date20 Jan 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- Withdrawn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
- SuperGuard ( Black Nitrile )Maxwell
- Device Name
- Powder Free Nitrile Examination GlovesPowder Free Latex Examination Gloves
- Model / Reference
- S, L, XS, M, XL
- Primary DI / UDI-DI
- 09555586002678, 09555586002692, 09555586001671, 09555586002265, 09555586000827, 09555586001619, 09555586002593, 09555586000803, 09555586002289, 09555586000841, 09555586001664, 09555586002562, 09555586002586, 09555586001640, 09555586002302, 09555586002401, 09555586000834, 09555586002579, 09555586000810, 09555586002395
- Basic UDI-DI
- 955558600248LK, 955558600247LH
- EMDN Code
- T01020204, T010201
- Device Class
- Class I
- EU market of registration
- IrelandGreeceLithuaniaSpain
Manufacturer details
- EUDAMED SRN
- MY-MF-000016723
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Maxwell Glove Manufacturing Berhad
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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