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 Large FDA UDI
- Model / Reference
- 5701943 EUDAMEDFDA UDITF-253 (HS) EUDAMED
- Description
- Criterion CL2 PF Latex Glove Large FDA UDI
Identifiers
- Catalog Number
- 5701943 FDA UDI
- Primary DI / UDI-DI
- 10304040131647 EUDAMEDFDA UDI
- Basic UDI-DI
- 03040425301C9 EUDAMED
- Unit of Use DI
- 00304040131640 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
Yes
Reprocessed
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Criterion CL2 by Henry Schein, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Henry Schein, Inc.
Sources (2)
- FDA UDI 1e912ea2-50dd-4aa8-9938-dbf69d65d3bd 35 fields · synced Oct 6, 2026
- EUDAMED 41c84235-2270-4c17-bf10-3f0f947076f5 61 fields · synced Oct 6, 2026