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The Sea Nitrile Powder Free Textured Dark Blue Examination Glove
EUDAMEDFDA UDIClass I (EU MDR)
Ref TS 22216-DB-N-PFModel Nitrile Examination Powder Free Glove
Identity
- Trade Name
- THE SEA NITRILE POWDER FREE TEXTURED DARK BLUE EXAMINATION GLOVE EUDAMEDTHE SEA FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- NITRILE POWDER FREE TEXTURED DARK BLUE EXAMINATION GLOVE- SHARK (SMALL) FDA UDI
- Model / Reference
- Nitrile Examination Powder Free Glove EUDAMEDTS 22216-DB-N-PF EUDAMEDFDA UDI
- Description
- NITRILE POWDER FREE TEXTURED DARK BLUE EXAMINATION GLOVE- SHARK (SMALL) FDA UDI
Identifiers
- Catalog Number
- TS 22216-DB-N-PF FDA UDI
- Primary DI / UDI-DI
- 00723860222169 EUDAMEDFDA UDI
- Basic UDI-DI
- 0723860562869H EUDAMED
- FDA Product Code
- LZA FDA UDI
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
- GMDN Term
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
The Sea Nitrile Powder Free Textured Dark Blue Examination Glove by Mexpo International, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0723860562869H | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mexpo International, Inc.
- EUDAMED SRN
- US-MF-000032548
- Authorised Representative
- Blossom Europe, S.L. ES-AR-000019689
Sources (2)
- EUDAMED 179abc2c-b245-452d-9db8-b46e71fa4362 61 fields · synced Jun 18, 2026
- FDA UDI aa5ae45f-b49c-4106-8b15-389ac9376dab 34 fields · synced May 30, 2026