← Back to catalogue
Vinyl examination gloves
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref KG-3101E(L)Model KG-3101E(S)
Identity
- Device Name
- Vinyl examination gloves EUDAMED
- Model / Reference
- KG-3101E(S) EUDAMEDKG-3101E(L) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976739562113 EUDAMED
- Basic UDI-DI
- 697673956KG-3101NM EUDAMED
- EMDN Code
- T01020201 VINYL EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Vinyl examination gloves by Guangdong Kingfa Sci. & Tech. Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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 | K230046 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697673956KG-3101NM | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guangdong Kingfa Sci. & Tech. Co., Ltd.
- EUDAMED SRN
- CN-MF-000009520
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED f4395576-0478-4f4e-8523-9f898db10347 61 fields · synced Jun 18, 2026
- FDA 510(k) K230046 1 fields · synced May 18, 2026