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ARsafe ® Powdered Nitrile Examination Gloves, Blue, size XS
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref NG-01BModel NG
Identity
- Trade Name
- ARsafe ® Powdered Nitrile Examination Gloves, Blue, size XS EUDAMED
- Device Name
- Powdered Nitrile Examination Gloves EUDAMED
- Model / Reference
- NG EUDAMEDNG-01B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555867102608 EUDAMED
- Basic UDI-DI
- 955586710NG4J EUDAMED
- Unit of Use DI
- 29555867102602 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ARsafe ® Powdered Nitrile Examination Gloves, Blue, size XS by Alliance Rubber Products Sdn. Bhd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K980589 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 955586710NG4J | Class I | Active |
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Manufacturer
- Manufacturer
- Alliance Rubber Products Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000008415
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 1e30a36f-eb51-4200-b3e3-232d92aa8179 61 fields · synced Jul 10, 2026
- FDA 510(k) K980589 1 fields · synced May 18, 2026