Prestige Nitrile Care
by Hartalega NGC Sdn. Bhd. 3 variants
Ref XL, L, XS, MModel Nitrile Powder Free Examination Gloves with Colloidal Oatmeal, Nitrile Powder Free Examination 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 | Number955100777HNGCTFMD007XJ | 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- Withdrawn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
- Trade Name
- Prestige Nitrile CarePrestige Nitrile
- Device Name
- Nitrile Powder Free Examination GlovesNitrile Examination Gloves
- Model / Reference
- Nitrile Powder Free Examination Gloves with Colloidal Oatmeal, XL, Nitrile Powder Free Examination Gloves, L, XS, M
- Primary DI / UDI-DI
- 19551025940690, 19551025940546, 19551025940553, 19551025940515, 19551025940676, 19551025940683
- Basic UDI-DI
- 955100777HNGCTFMD007XJ, 955100777HNGCTFMD005AQ8
- Unit of Use DI
- 09551025940549, 09551025940556, 09551025940518, 09551025940679
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- Market of Registration
- Norway
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