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Safari Nitrile Examination Gloves Powder Free Ivory
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref SFR 88586-N-PFModel Nitrile Examination Powder Free GloveRef SFR 88588-N-PFRef SFR 88585-N-PFRef SFR 88587-N-PF
Identity
- Trade Name
- SAFARI NITRILE EXAMINATION GLOVES POWDER FREE IVORY EUDAMED
- Model / Reference
- Nitrile Examination Powder Free Glove EUDAMEDSFR 88586-N-PF EUDAMEDSFR 88588-N-PF EUDAMEDSFR 88585-N-PF EUDAMEDSFR 88587-N-PF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00723860885869 EUDAMED00723860885883 EUDAMED00723860885852 EUDAMED00723860885876 EUDAMED
- Basic UDI-DI
- 0723860562869H EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Safari Nitrile Examination Gloves Powder Free Ivory by Mexpo International, Inc. — 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 | K213681 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0723860562869H | Class I | Active |
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Manufacturer
- Manufacturer
- Mexpo International, Inc.
- EUDAMED SRN
- US-MF-000032548
- Authorised Representative
- Blossom Europe, S.L. ES-AR-000019689
Sources (5)
- EUDAMED 32dfc2f0-ff46-42d6-b6c8-c02cd4924cfe 61 fields · synced Oct 6, 2026
- EUDAMED 00b96bcf-c706-4483-9fac-2379f57fbd42 61 fields · synced May 17, 2026
- EUDAMED a688b209-1c80-42ab-b94c-17c07314d0e4 61 fields · synced May 18, 2026
- EUDAMED f966dbde-a452-40f7-a86b-2db3ed1c6356 61 fields · synced May 18, 2026
- FDA 510(k) K213681 1 fields · synced May 18, 2026