Identity
- Trade Name
- REFLECTION POLYCHLOR PF EXAM GRN FDA UDI
- Generic Name
- Polychloroprene examination/treatment glove, non-powdered FDA UDI
- Model / Reference
- 433061 FDA UDI
Identifiers
- Catalog Number
- 433061 FDA UDI
- Primary DI / UDI-DI
- D7664330611 FDA UDI
- FDA Product Code
- LZA FDA UDI
- GMDN Term
- Polychloroprene examination/treatment glove, non-powdered 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
No
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: Polychloroprene examination/treatment glove, non-powdered
Reflection Polychlor Pf Exam Grn by Smart Health Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polychloroprene examination/treatment glove, non-powdered.
- Dental City — ICP, INC. · Class I
- The Orthodontic Store — Young Innovations, Inc. · Class I
- BLOSSOM — Mexpo International, Inc. · Class I
- Criterion CR Chloroprene Glove — HENRY SCHEIN, INC. · Class I
- Cranberry — ASCEND EAGLE INCORPORATED · Class I
- The Orthodontic Store — Young Innovations, Inc. · Class I
- Peridot — TRANZONIC ACQUISITION CORP. · Class I
- Pulse® CR Aqua — INNOVATIVE HEALTHCARE CORPORATION · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smart Health Llc
Sources (1)
- FDA UDI d7d5b7d6-248d-4ad8-90f5-92940ec0c3b3 33 fields · synced Jun 8, 2026