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Powder-Free Nitrile Examination Gloves
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
510(k) K041276Ref 7235
Identity
- Trade Name
- Powder- free Nitrile Examination Gloves EUDAMED
- Device Name
- Powder-free Nitrile Examination Glove EUDAMED
- Model / Reference
- 7235 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930518002644 EUDAMED
- Basic UDI-DI
- 69305180ANB200037C EUDAMED
- 510(k) Number
- K041276 FDA 510(k)
- FDA Product Code
- LZA FDA 510(k)
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMEDFDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6250 FDA 510(k)
- Regulation Number
- 880.6250 FDA 510(k)
- Market of Registration
- Norway EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
Powder-Free Nitrile Examination Gloves by Shanghai Motex Healthcare Co., Ltd. — Class I — MDR, FDA_510K — listed in FDA 510(k), EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K041276 | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Motex Healthcare Co., Ltd.
Sources (2)
- FDA 510(k) K041276 24 fields · synced Oct 6, 2026
- EUDAMED bf9676c4-7820-452e-80f2-6596f296f758 61 fields · synced Jul 14, 2026