Identity
- Trade Name
- VR FDA UDI
- Generic Name
- Surgical/examination garment kit FDA UDI
- Device Name
- Sleeve Gloves 15 Mil Extra Small Green Lined - Case 100 Ct. FDA UDI
- Model / Reference
- 41280 FDA UDI
- Description
- Sleeve Gloves 15 Mil Extra Small Green Lined - Case 100 Ct. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10855956008122 FDA UDI
- FDA Product Code
- LZB FDA UDI
- GMDN Term
- Surgical/examination garment kit 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical/examination garment kitUtility glove
Vr by Polyconversions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Utility glove.
- Latex Free Donning Gloves — SIGVARIS, INC. · Class I
- Textile Donning Gloves — SIGVARIS, INC. · Class I
- Textile Donning Gloves — SIGVARIS, INC. · Class I
- Latex Free Donning Gloves — SIGVARIS, INC. · Class I
- VIVE — VIVE HEALTH LLC · Class I
- Knobby Donning Gloves — SIGVARIS, INC. · Class I
- Specfit — Vallen Distribution, Inc. · Class I
- Latex Free Donning Gloves — SIGVARIS, INC. · 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
- Polyconversions, Inc.
Sources (1)
- FDA UDI fd1090f7-a0b9-471d-9292-1aa4aa475922 33 fields · synced Jun 8, 2026