Identity
- Trade Name
- FlexGard FDA UDI
- Generic Name
- Glove liner FDA UDI
- Device Name
- Cut resistant glove liners, sterile, size 3X-large. (Packaged 10 pair/box. Invoiced by pair.) FDA UDI
- Model / Reference
- CRG-S3XL-MTF FDA UDI
- Description
- Cut resistant glove liners, sterile, size 3X-large. (Packaged 10 pair/box. Invoiced by pair.) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010353257 FDA UDI
- 510(k) Number
- K190782 FDA UDI
- FDA Product Code
- KGO FDA UDI
- GMDN Term
- Glove liner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4460 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glove liner
FlexGard by LDI Solutions, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glove liner.
- LIFE LINER — DEPUY ORTHOPAEDICS, INC. · Class I
- GLOVE LINER — George Glove Company, Inc. · Class I
- LIFE LINER — DEPUY ORTHOPAEDICS, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- REPEL — DEPUY ORTHOPAEDICS, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- GLOVE LINER — George Glove Company, Inc. · Class I
- REPEL — DEPUY ORTHOPAEDICS, INC. · Class I
Cleared under the same submission
K190782 also covers:
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
- LDI Solutions, LLC
Sources (1)
- FDA UDI c4541e89-ce3a-4d3c-8cca-e6b4234769ff 34 fields · synced May 30, 2026