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Disposable Nitrile Medical Examination Glove
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref XS510(k) K223281
Identity
- Device Name
- DISPOSABLE NITRILE MEDICAL EXAMINATION GLOVE EUDAMED
- Model / Reference
- XS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972880629906 EUDAMED
- Basic UDI-DI
- 697288062NMEGRD EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Disposable Nitrile Medical Examination Glove by Anhui Kindguard Medical Supplies Technology Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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 | K223281 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697288062NMEGRD | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000033762
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 22489d7c-869d-4a7f-b29d-2caf0ab754f3 85 fields · synced Jun 18, 2026
- FDA 510(k) K223281 1 fields · synced May 18, 2026