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Zense Latex Powder Free Examination Gloves
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 5707Ref 5708
Identity
- Trade Name
- Zense Latex Powder Free Examination Gloves EUDAMED
- Device Name
- Latex Powdered Free Examination Gloves EUDAMED
- Model / Reference
- 5707 EUDAMED5708 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555123602385 EUDAMED09555123602392 EUDAMED
- Basic UDI-DI
- 955512360CISBPFLN7 EUDAMED
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Zense Latex Powder Free Examination Gloves by Cranberry International 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 | K935946 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 955512360CISBPFLN7 | Class I | Active |
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Manufacturer
- Manufacturer
- Cranberry International Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000004878
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED 1a5eb438-f5bc-4dc4-9391-db45b27366a5 61 fields · synced Jul 30, 2026
- EUDAMED bf33818b-fe55-425f-8e16-9e7020fe997d 61 fields · synced May 17, 2026
- FDA 510(k) K935946 1 fields · synced May 18, 2026