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ProLatex Non Sterile Powder Free Single Chlorinated Latex Examination Gloves
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref LBACT1060
Identity
- Trade Name
- ProLatex Non Sterile Powder Free Single Chlorinated Latex Examination Gloves EUDAMED
- Device Name
- Non Sterile Powder Free Latex Examination Gloves EUDAMED
- Model / Reference
- LBACT1060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551012180941 EUDAMED
- Basic UDI-DI
- 955101218PFLATEXKJ EUDAMED
- EMDN Code
- T010201 LATEX 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
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
ProLatex Non Sterile Powder Free Single Chlorinated Latex Examination Gloves by Professional Latex Sdn Bhd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA…
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 | K173053 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 955101218PFLATEXKJ | Class I | Active |
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Manufacturer
- Manufacturer
- Professional Latex Sdn Bhd
- EUDAMED SRN
- MY-MF-000009415
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED b4e87c94-a538-4bad-8768-a2da478958ba 61 fields · synced Jun 19, 2026
- FDA 510(k) K173053 1 fields · synced May 18, 2026