Identity
- Trade Name
- REFLECTION LATEX PF EXAM BL MD FDA UDI
- Generic Name
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- GLV REFLECTION LATEX PF EXAM BL MED*100 FDA UDI
- Model / Reference
- 43214 FDA UDI
- Description
- GLV REFLECTION LATEX PF EXAM BL MED*100 FDA UDI
Identifiers
- Catalog Number
- 43214 FDA UDI
- Primary DI / UDI-DI
- D766432141 FDA UDI
- FDA Product Code
- LYY FDA UDI
- GMDN Term
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Reflection Latex Pf Exam Bl Md by Smart Health Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Smart Health Llc
Sources (1)
- FDA UDI ae37fe1e-fade-4e29-bb48-c0c3aa1e334b 37 fields · synced Jun 1, 2026