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The Sea Nitrile Powder Free Textured Black Examination Gloves
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref TS 22159-B-N-PFModel Nitrile Examination Powder Free GloveRef TS 22158-B-N-PF
Identity
- Trade Name
- THE SEA NITRILE POWDER FREE TEXTURED BLACK EXAMINATION GLOVES EUDAMED
- Model / Reference
- Nitrile Examination Powder Free Glove EUDAMEDTS 22159-B-N-PF EUDAMEDTS 22158-B-N-PF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00723860221599 EUDAMED00723860221582 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
The Sea Nitrile Powder Free Textured Black Examination Gloves 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 | K172867 | 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 (3)
- EUDAMED 0ae52007-d06d-4c19-8978-561fb9a77c63 61 fields · synced Oct 6, 2026
- EUDAMED f9e901a5-41e6-47fd-8b8b-8179f7ee5725 61 fields · synced May 18, 2026
- FDA 510(k) K172867 1 fields · synced May 18, 2026