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Disposable Nitrile Examination Gloves 4.0g Powder-free Blue M
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref Nitrile EM seriesModel EM0102
Identity
- Trade Name
- Disposable Nitrile Examination Gloves 4.0g Powder-free Blue M EUDAMED
- Device Name
- Disposable Nitrile Examination Gloves, Powder Free EUDAMED
- Model / Reference
- EM0102 EUDAMEDNitrile EM series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933265512978 EUDAMED
- Basic UDI-DI
- 69332655EM01021562864B EUDAMED
- Direct Marketing DI
- 06933265512978 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Disposable Nitrile Examination Gloves 4.0g Powder-free Blue M by Blue Sail Medical Co., Ltd — 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 | K163126 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69332655EM01021562864B | Class I | Active |
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Manufacturer
- Manufacturer
- Blue Sail Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000001139
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED e953cfdc-3d2f-4417-9839-08c7069b997a 61 fields · synced Oct 6, 2026
- FDA 510(k) K163126 1 fields · synced Jun 9, 2026