Oats Gloves
by Hartalega NGC Sdn. Bhd. 5 variants
Ref RNBOXLModel Nitrile Powder Free Examination Gloves with Colloidal Oatmeal
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 | Number955100777HNGCTFMD007XJ 09551017620190 | Date18 Feb 2025 | 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- Withdrawn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
- Nitrile Powder Free Examination Gloves
- Model / Reference
- Nitrile Powder Free Examination Gloves with Colloidal Oatmeal, RNBOXL
- Primary DI / UDI-DI
- 09551017620190
- Basic UDI-DI
- 955100777HNGCTFMD007XJ
- Unit of Use DI
- 09551017620268
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- MY-MF-000010459
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Hartalega Ngc Sdn. Bhd.
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