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Disposable Nitrile Gloves
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref XC101510(k) K213851
by Guangdong Xingcan Brothers Medical Technology Co., Limited
Identity
- Device Name
- Disposable Nitrile Gloves EUDAMED
- Model / Reference
- XC101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973847120016 EUDAMED
- Basic UDI-DI
- 697384712DNG01K9 EUDAMED
- EMDN Code
- T010299 EXAMINATION / TREATMENT GLOVES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Gloves by Guangdong Xingcan Brothers Medical Technology Co., Limited — 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 | K213851 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697384712DNG01K9 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000043488
- FDA Applicant
- Guangdong Xingcan Brothers Medical Technology Co.,Ltd
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED dc09a975-323d-457e-ac28-814bb0f6fc33 85 fields · synced Jun 19, 2026
- FDA 510(k) K213851 1 fields · synced May 18, 2026