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Safeplus® Powder Free Latex Examination Gloves, size L
EUDAMEDFDA UDIClass I (EU MDR)
Ref LGPF-04Model LGPF
Identity
- Trade Name
- Safeplus® Powder Free Latex Examination Gloves, size L EUDAMEDSafe Plus FDA UDI
- Generic Name
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Powder Fee Latex Examination Gloves EUDAMEDPowder Free Polymer Coated Latex Exam/Disposable Glove, Size L FDA UDI
- Model / Reference
- LGPF EUDAMEDLGPF-04 EUDAMEDFDA UDI
- Description
- Powder Free Polymer Coated Latex Exam/Disposable Glove, Size L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09555867100161 EUDAMEDFDA UDI
- Basic UDI-DI
- 955586710LGPFQS EUDAMED
- Unit of Use DI
- 29555867100165 EUDAMED
- FDA Product Code
- LYY FDA UDI
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
- GMDN Term
- Hevea-latex 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
- Austria 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Safeplus® Powder Free Latex Examination Gloves, size L by Alliance Rubber Products Sdn. Bhd. — 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 | 955586710LGPFQS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Alliance Rubber Products Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000008415
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED a7d1da3f-9583-4369-b32a-b91f8ef4acf7 61 fields · synced Jun 19, 2026
- FDA UDI 56ccf243-2de9-4255-ab3f-3b63d123c415 34 fields · synced May 30, 2026