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Nitril Plus 300S
EUDAMEDFDA UDIClass I (EU MDR)
Ref SNPF 1005Model XS, S, M, L, XL
Identity
- Trade Name
- Nitril Plus 300S EUDAMEDHongray FDA UDI
- Generic Name
- Vinyl examination/treatment glove, non-powdered FDA UDI
- Device Name
- Sterile Nitrile Examination Gloves EUDAMEDPowder Free Vinyl Patient Examination Glove, Clear, 2X-Large – 100/box FDA UDI
- Model / Reference
- XS, S, M, L, XL EUDAMEDSNPF 1005 EUDAMEDXXL FDA UDI
- Description
- Powder Free Vinyl Patient Examination Glove, Clear, 2X-Large – 100/box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973951581185 EUDAMEDFDA UDI
- Basic UDI-DI
- 697395158NEUS100XKA EUDAMED
- FDA Product Code
- LYZ FDA UDI
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
- GMDN Term
- Vinyl examination/treatment glove, non-powdered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Nitril Plus 300S by Grand Work Plastic Products Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 697395158NEUS100XKA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Grand Work Plastic Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000023986
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED cd229b65-7a3f-4b88-a7ca-453746962b21 61 fields · synced Jun 18, 2026
- FDA UDI 711c6806-814c-466c-bc17-55ef79dded47 34 fields · synced May 22, 2026