Identity
- Trade Name
- Henry Schein EUDAMEDCriterion CL2 FDA UDI
- Generic Name
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Latex Examination glovesGloves EUDAMEDCriterion CL2 PF Latex Glove X-Large FDA UDI
- Model / Reference
- TF-253 (HS) EUDAMED5701944 EUDAMEDFDA UDI
- Description
- Criterion CL2 PF Latex Glove X-Large FDA UDI
Identifiers
- Catalog Number
- 5701944 FDA UDI
- Primary DI / UDI-DI
- 10304040131678 EUDAMEDFDA UDI
- Basic UDI-DI
- 03040425301C9 EUDAMED
- Unit of Use DI
- 00304040131671 EUDAMED
- FDA Product Code
- LYY FDA UDI
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
- GMDN Term
- Hevea-latex 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Henry Schein by Henry Schein, Inc. — Class I — 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 | 03040425301C9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Henry Schein Inc.
- EUDAMED SRN
- US-MF-000021683
- Authorised Representative
- Henry Schein Services GmbH DE-AR-000008001
Sources (2)
- EUDAMED 3edc60a4-e4a0-4485-9afb-ebd89ea16760 61 fields · synced Jul 18, 2026
- FDA UDI ebe9b25c-cdcc-40db-9069-31bf77b85d41 35 fields · synced May 30, 2026