Identity
- Trade Name
- HUAYUAN EUDAMEDFDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Nitrile Examination Gloves EUDAMEDNitrile examination gloves,blue,M FDA UDI
- Model / Reference
- nitrile,blue,M EUDAMEDNitrile FDA UDI
- Description
- Nitrile examination gloves,blue,M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973082130115 EUDAMEDFDA UDI
- Basic UDI-DI
- 697308213NBR-HY-01AA EUDAMED
- 510(k) Number
- K131823 FDA UDI
- 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
- Finland 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
Yes
FDA UDI
Huayuan by Dongtai City Huayi Gloves 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 | 697308213NBR-HY-01AA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dongtai City Huayi Gloves Co., Ltd.
- EUDAMED SRN
- CN-MF-000019047
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED bb6e0030-2625-4a2b-9e99-f2eeb22baac6 61 fields · synced May 30, 2026
- FDA UDI f568c2cf-d489-4f8d-b82e-a0cb9b5cc888 35 fields · synced May 30, 2026