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Powder-free Nitrile Examination Gloves
EUDAMEDFDA UDIClass I (EU MDR)
Ref 7235Model 7235 /7236
Identity
- Trade Name
- Powder-free Nitrile Examination Gloves EUDAMEDMocareHealth FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Powder -free Nitrile Examination Gloves EUDAMEDSingle-Use Nitrile Examination Gloves FDA UDI
- Model / Reference
- 7235 /7236 EUDAMED7235 EUDAMED7235M FDA UDI
- Description
- Single-Use Nitrile Examination Gloves FDA UDI
Identifiers
- Primary DI / UDI-DI
- 26971384150033 EUDAMEDFDA UDI
- Basic UDI-DI
- 697138415ANB20003HA EUDAMED
- 510(k) Number
- K030207 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
- Germany 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
Yes
EUDAMEDFDA UDI
Reprocessed
Yes
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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Powder-free Nitrile Examination Gloves by Motex Healthcare (anhui) Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 697138415ANB20003HA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Motex Healthcare (anhui) Co., Ltd.
- EUDAMED SRN
- CN-MF-000014097
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 9d032eda-6e6e-430c-91d4-9e03d1b90d27 61 fields · synced Jun 8, 2026
- FDA UDI b9a2e2ab-bcdd-482a-9e23-982daa92b867 34 fields · synced May 27, 2026