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Sterile Surgical gloves1610
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1610Model 2721, 2729, 2821, 2829, 2921, 2929, 2721F, 2721S, 2729F, 2729S, 2821S, 2829F, 2921S
Identity
- Trade Name
- Sterile Surgical gloves1610 EUDAMEDMocareHealth FDA UDI
- Generic Name
- Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Sterile Surgical gloves EUDAMEDSingle-use sterile rubber surgical gloves FDA UDI
- Model / Reference
- 2721, 2729, 2821, 2829, 2921, 2929, 2721F, 2721S, 2729F, 2729S, 2821S, 2829F, 2921S EUDAMED1610 EUDAMED1610/7 FDA UDI
- Description
- Single-use sterile rubber surgical gloves FDA UDI
Identifiers
- Primary DI / UDI-DI
- 26971384150880 EUDAMEDFDA UDI
- Basic UDI-DI
- 697138415CNR20002QW EUDAMED
- 510(k) Number
- K063757 FDA UDI
- FDA Product Code
- KGO FDA UDI
- EMDN Code
- T01010102 NON-POWDERED LATEX SURGICAL GLOVES EUDAMED
- GMDN Term
- Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4460 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
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
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
Radiation Sterilization FDA UDI
Sterile Surgical gloves1610 by Motex Healthcare (anhui) Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 697138415CNR20002QW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 489162be-6431-4ffc-9b1f-a102c3d30f9d 61 fields · synced Jun 19, 2026
- FDA UDI 15a00842-e95e-4593-8cb5-caa5c7d40cc9 34 fields · synced May 30, 2026