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Gold Fingers ® Powder Free Latex Examination Gloves, size XL
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref LGPF-02Model LGPF
Identity
- Trade Name
- Gold Fingers ® Powder Free Latex Examination Gloves, size XL EUDAMEDGold Fingers FDA UDI
- Generic Name
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Powder Fee Latex Examination Gloves EUDAMEDPowder Free Chlorinated Latex Exam/Disposable Glove, Size XL FDA UDI
- Model / Reference
- LGPF EUDAMEDLGPF-02 EUDAMEDFDA UDI
- Description
- Powder Free Chlorinated Latex Exam/Disposable Glove, Size XL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09555867100123 EUDAMEDFDA UDI
- Basic UDI-DI
- 955586710LGPFQS EUDAMED
- Unit of Use DI
- 29555867100127 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
- Northern Ireland 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
Gold Fingers ® Powder Free Latex Examination Gloves, size XL by Alliance Rubber Products Sdn. Bhd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID…
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 | K971183 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 955586710LGPFQS | Class I | Active |
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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 (3)
- EUDAMED 2bd7eeb9-1785-4965-8134-248378bd16fc 61 fields · synced Oct 6, 2026
- FDA UDI 41cf045c-f751-44c5-af67-341a605aacf7 34 fields · synced May 30, 2026
- FDA 510(k) K971183 1 fields · synced May 18, 2026