FDA UDI
In Commercial Distribution
🇺🇸 United States
GLOVE LINER
DI: 00860011003014
·
Model: 71211
·
George Glove Company, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- GLOVE LINER
- Primary DI
- 00860011003014
- Version / Model
- 71211
- Company Name
- George Glove Company, Inc.
- Labeler DUNS
- 012033346
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2023-10-26
- Public Version
- 1
- Public Version Date
- 2023-11-03
- Public Version Status
- New
- Public Device Record Key
- 599d249d-dc00-4c12-b52b-adcde0f57103
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LYU | ACCESSORY, SURGICAL APPAREL | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18039 | Glove liner | A cloth glove intended to be worn as a liner underneath rubber, plastic, or latex gloves (examination or surgical) to minimize the risk of allergic reactions, rashes, and other skin irritations, or to reduce the risk of sharps injuries. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00860011003052 | GS1 | ||||
| Primary | 00860011003014 | GS1 |