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ARsoft ® Powder Free Nitrile Examination Gloves, Blue, size XXL
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref NGPF-01BModel NGPF
Identity
- Trade Name
- ARsoft ® Powder Free Nitrile Examination Gloves, Blue, size XXL EUDAMEDARsoft FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Powder Free Nitrile Examination Gloves EUDAMED4mils Powder Free Blue Nitrile Exam/Disposable Glove, Size XXL FDA UDI
- Model / Reference
- NGPF EUDAMEDNGPF-01B EUDAMEDNGPF-01 FDA UDI
- Description
- 4mils Powder Free Blue Nitrile Exam/Disposable Glove, Size XXL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09555867100239 EUDAMEDFDA UDI
- Basic UDI-DI
- 955586710NGPFR8 EUDAMED
- Unit of Use DI
- 29555867100233 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
- 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ARsoft ® Powder Free Nitrile Examination Gloves, Blue, size XXL by Alliance Rubber Products 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 | K983146 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 955586710NGPFR8 | 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 725f8206-e772-409f-9f93-417590ac16d4 61 fields · synced Oct 6, 2026
- FDA UDI 8e40edce-d36b-4bf6-ba54-2743f6f2a506 34 fields · synced May 30, 2026
- FDA 510(k) K983146 1 fields · synced May 18, 2026