Vasco Nitril Semilong White
by Hartalega Sdn. Bhd. EUDAMED510(k)
Active
Ref 9205945Model Nitrile Powder Free Examination Gloves
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number955524480HSBTFMD002A5A | Date1 Dec 2022 | StatusActive |
| United States | FDA 510(k) 510(k) | NumberK110758 | Date12 Aug 2011 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- United States
- European Union
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 23 Oct 2026.
Specification
- Device Name
- Nitrile Examination Gloves
- Model / Reference
- Nitrile Powder Free Examination Gloves, 9205945
- Primary DI / UDI-DI
- 04046955059164
- Basic UDI-DI
- 955524480HSBTFMD002A5A
- Unit of Use DI
- 04046955145669
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- MY-MF-000010461
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Hartalega 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