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Sterile Nitrile Examination Gloves
EUDAMEDFDA UDIClass I (EU MDR)
Ref SNPF 1002Model XS, S, M, L, XLRef GUA 155
Identity
- Trade Name
- Sterile Nitrile Examination Gloves EUDAMEDNitrile Examination Gloves EUDAMEDHongray FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Sterile Nitrile Examination Gloves EUDAMEDSterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue), Small – 2/pouch FDA UDI
- Model / Reference
- XS, S, M, L, XL EUDAMEDSNPF 1002 EUDAMEDGUA 155 EUDAMEDS FDA UDI
- Description
- Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue), Small – 2/pouch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973951580027 EUDAMEDFDA UDI06973951581987 EUDAMED
- Basic UDI-DI
- 697395158NEUS100XKA EUDAMED
- FDA Product Code
- LZA FDA UDILZC FDA UDIQDO 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
- Ireland EUDAMEDItaly 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
Sterile Nitrile Examination Gloves by Grand Work Plastic Products Co., Ltd. — 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 | 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 (3)
- EUDAMED da725c79-2740-4f1e-abc1-5fb1f905a250 61 fields · synced Jul 13, 2026
- FDA UDI 9eda982d-0f17-4018-8201-14a013d47344 33 fields · synced May 29, 2026
- EUDAMED dfdf91d7-27fc-4d1d-9fc2-0afa7bfde6e3 61 fields · synced Jul 13, 2026