FDA UDI
In Commercial Distribution
🇺🇸 United States
Next Generation Stretch Vinyl Exam Gloves
DI: 00709553682427
·
Model: 6824
·
DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Next Generation Stretch Vinyl Exam Gloves
- Primary DI
- 00709553682427
- Version / Model
- 6824
- Company Name
- DYNAREX CORPORATION
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2021-05-21
- Public Version
- 2
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- 91f72608-3c0f-4921-ac7e-94cc59eb9b78
Device Description
Next Generation Stretch Vinyl Exam Gloves, Powder-Free, Large
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
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59821 | Ethylene vinyl acetate examination/treatment glove, non-powdered | A device made of ethylene vinyl acetate (EVA) copolymer intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00709553682434 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00709553682427 | GS1 | ||||
| Unit of Use | 00709553682410 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100486 | 000 |